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Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors (F2TMind)

Primary Purpose

Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Core Intervention
E-Coach
Buddy
General Mindfulness Training
MVPA-Specific Mindfulness Training
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, e-health, physical activity, mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: For BCS Female, age 18 years or older Stage I-III breast cancer diagnosis within the past 5 years Diagnosis of cancer between 18-39 years and within the past 5 years ≥3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies Self-report engagement in <60 min/week of MVPA Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willingness to obtain medical clearance from a primary care physician or oncologist Internet access and smartphone ownership Fluency in spoken and written English Willingness to find a buddy (someone who knows about their cancer and participation in this study and who is willing to participate by supporting them during the 24-week study), if assigned to that condition For "Buddies" Friend, co-worker, caregiver or family member of a participating BCS Age 18 years or older Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willing to obtain medical clearance from a primary care physician Internet access and smartphone ownership Fluency in spoken and written English Willingness to share their Fitbit data with the study team Exclusion Criteria: Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery Currently pregnant or plans to become pregnant Plans to move out of the United States in next 18 months Current enrollment in another dietary or physical activity trial Inability to provide informed consent Prisoners or other detained individuals

Sites / Locations

  • Northwestern University

Arms of the Study

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Arm Type

Experimental

Active Comparator

Active Comparator

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Active Comparator

Arm Label

Exp Condition 1

Exp Condition 2

Exp Condition 3

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Arm Description

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training

Research participant receives the Core Intervention + E-Coach + Buddy

Research participant receives the Core Intervention + E-Coach

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy

Research participant receives the Core Intervention + E-Coach + General Mindfulness Training

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy

Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training

Research participant receives the Core Intervention + General Mindfulness Training + Buddy

Research participant receives the Core Intervention + General Mindfulness Training

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy

Research participant receives the Core Intervention + MVPA Specific Mindfulness Training

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy

Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training

Research participant receives the Core Intervention + Buddy

Research participant receives the Core Intervention

Outcomes

Primary Outcome Measures

Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors
Physical activity will be measured at baseline, 24 and 48 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). Minutes of moderate and vigorous physical activity will be used to assess change.

Secondary Outcome Measures

Anxiety in breast cancer survivors
Symptom burden of anxiety will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a.
Depression in breast cancer survivors
Symptom burden of depression will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a.
Fatigue in breast cancer survivors
Symptom burden of fatigue will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Fatigue - Short Form 8a.
Physical Function in breast cancer survivors
Physical function will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v. 1.0 - Physical Function - Short Form 20a.
Sleep Disturbance in breast cancer survivors
Symptom burden of sleep disturbance will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Sleep Disturbance - Short Form 8a.
Sleep Impairment in breast cancer survivors
Symptom burden of sleep disturbance will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a.
Applied Cognition Abilities in breast cancer survivors
Symptom burden on applied cognitive abilities will be measured at baseline, 24 and 48 weeks using the PROMIS v1.0-Applied Cognition-Abilities-Short Form 8a.
Emotional Support in breast cancer survivors
Symptom burden on emotional support will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v2.0 - Emotional Support.
Self-Esteem in breast cancer survivors
Symptom burden on self-esteem will be measured at baseline, 24 and 48 weeks using the Rosenberg Self-Esteem Scale. This scale assesses global self-esteem and consists of 10-items asking participants to indicate their level of agreement/disagreement with each statement. Sample items include: "I feel that I'm a person of worth, at least on an equal basis with others;" and "I am able to things as well as most people." Participants respond on a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The minimum value one can score is 10, and the maximum is 50. Higher scores indicate a better outcome.
Social support for exercise in breast cancer survivors
Social support for exercise will be measured at baseline, 24 and 48 weeks using the Social Support for Exercise Scale. This scale assesses support for physical activity received from the following categories: family, friends, and other cancer survivors. Statements are scored on a Likert scale of 1 (never) to 5 (very often) for each of the three categories, with higher scores representing better outcome. The minimum value one can score for each category is 10, and the maximum is 50. The minimum value of the total measure is 30, and the maximum is 150. An additional "does not apply" response option is provided on the measure.
Physical self-perception in breast cancer survivors
Physical Self-Perception will be measured at baseline, 24 and 48 weeks using the Physical Self-Perception Profile-Physical Self-worth Subscale. This instrument used to assess self-esteem relative to several domains of physical functioning in a hierarchical, multidimensional fashion. The instrument contains a general physical self-worth scale (PSW) which subsumes four more specific scales of perceived sport competence (SPORT), physical condition (COND), attractive body (BODY), and strength (STRENGTH), with six items per scale. Participants indicated on a four-point scale the degree to which each item is characteristic or true of them. Responses range from 1 (not at all true) to 4 (completely true), with higher scores representing better outcome. The minimum value one can score is 6, and the maximum is 24.
Enjoyment of Physical Activity in young adult cancer survivors
Enjoyment of Physical Activity will be measured at baseline, 24 and 48 weeks using the Physical Activity Enjoyment Scale. This 18-item scale assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7 point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). Eleven items are negatively worded and seven items are positively worded. After reverse scoring the 11 negatively worded items, an overall enjoyment for physical activity score is determined by summing the items, with a value range of 18-126 being possible. Higher scores indicate higher enjoyment, better outcome.
Leisure Time Physical Activity in breast cancer survivors
Leisure time physical activity will be measured at baseline, 24 and 48 weeks using the Godin Leisure Time Exercise Questionnaire Physical Activity. This is a measure of self-reported physical activity participation. Participants report "times per week" they participate in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and the "average duration each time you exercised (in minutes)" for each of the three activity categories. Weekly minutes of total, light, moderate, and vigorous activity are calculated by multiplying the frequency and time of each activity. This value is divided by 7 to obtain daily averages. The minimum value one can score is 0, and the maximum depends on the number of self-reported minutes of physical activity. Higher scores indicate better outcome.
Confidence in ability to be regularly active in breast cancer survivors
Confidence in ability to be regularly active will be measured at baseline, 24 and 48 weeks using the Exercise Self-Efficacy (EXSE). This short form assesses the participants' beliefs in their ability to be regularly active "for the next 12 weeks" on a scale from 0% (not at all confident) to 100% (completely confident), with higher scores representing better outcome.
Confidence in ability to be regularly active despite common barriers in breast cancer survivors
Confidence in ability to be regularly active despite common barriers will be measured at baseline, 24 and 48 weeks using the Barries Self-Efficacy (BARSE). This scale assesses the beliefs in ability to be regularly active despite common barriers "for the next 12 weeks" on a scale from 0% (not at all confident) to 100% (completely confident), with higher scores representing better outcome.
Exercise goal setting in breast cancer survivors
Exercise goal setting in breast cancer survivors will be measured at baseline, 24 and 48 weeks using the Exercise Goal Setting Scale. This scale assesses exercise goal setting behaviors on a scale from 1 (does not describe) to 5 (describes completely), with higher scores representing better outcome.
Sitting time in breast cancer survivors
Sitting time in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Sitting Time Questionnaire. This questionnaire assesses the amount of hours and minutes spent sitting during weekdays and weekends, with lower scores representing better outcome.
Outcome expectations for exercise in breast cancer survivors
Outcome expectations for exercise in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Outcome Expectations for Exercise_MOEES. This scale assesses the beliefs and expectations about the benefits of regular exercise and physical activity on a scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores representing better outcome.
Mindful Awareness in breast cancer survivors
Mindful awareness of distressing thoughts and images will be measured at baseline, 24 and 48 weeks using the Southampton Mindfulness Questionnaire (SMQ). This 16-item scale measures mindful awareness during distressing thoughts and images. Using a 7-point Likert scale (0=strongly disagree to 6=strongly agree), items reflect the following subscales: mindful observation (4 items), letting go (4 items), non- aversion (4 items), and non-judgment (4 items). The minimum value one can score on any of the subscales is 0, and the maximum is 24. The minimum value of the total measure is 0, and the maximum is 96. The higher scores represent better outcome.
Mindful self-compassion in breast cancer survivors
Mindful self-compassion will be measured at baseline, 24 and 48 weeks using the Self-Compassion Short Form. This short form is a 12-item scale measuring items related to self-kindness, self-judgment, and common humanity. Statements on the Self-Compassion Scale are scored on a Likert scale of 1 (almost never) to 5(almost always). To calculate an overall compassion score - Items representing uncompassionate responses to inadequacy or suffering (the self-judgment, isolation, and over-identification subscales) are reverse-coded only when calculating the overall compassion score. In this way, higher scores represent a lower frequency of these responses.
Post-traumatic growth in breast cancer survivors
Post-traumatic growth will be measured at baseline, 24 and 48 weeks using the Post-traumatic Growth Inventory. This 21-item self-report scale assesses growth or benefits after a specific traumatic life event. The Post Traumatic Growth Inventory (PTGI) is scored by adding all the responses, with higher scores representing better outcome.
Implementation feasibility measured by enrollment rate
This indicator of implementation feasibility for the interventions delivered is defined by the overall enrollment rate being >/= 70% (e.g., total number of individuals enrolled/total number approached). Enrollment rate will be tracked continuously during the 48 week study.
Implementation feasibility measured by retention rate
This indicator of implementation feasibility for the interventions delivered is defined by the retention rate being >/= 70% (e.g., total number of participants who drop out/ total number randomized). Retention rate will be tracked continuously during the 48 weeks of the study and significant differences between the study interventions in the number of participant withdrawals will be tracked.
Adherence to the study app + Fitbit by breast cancer survivors
Adherence to the study app + Fitbit will be monitored and usage tracked continuously during the 48 week study. Objective data include Fitbit wear time, number of times app is opened each week, time spent in app each time it is opened, and for participants who receive each component, usage of general and moderate to vigorous intensity physical activity specific mindfulness videos (i.e. whether clicked, how many times and for how long), number of e-coaching exchanges, number of buddy training webinars attended, and number of buddy interactions in the app.
Acceptability of the technology supported physical activity interventions as measured by a post-intervention evaluation survey
Acceptability will be measured using a brief, Likert-type survey assessing participant enjoyment, satisfaction, perceived benefit, and ease of use. Acceptability is defined as >/= 70% of survey responses in affirmation of this.
Change in body mass index in breast cancer survivors
Change in body mass index in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Health History Questionnaire, a local questionnaire developed by the study researchers. Participants will report on the following: height and most recent weight. BMI will be calculated. Significant change will be indicated by p<.05 on reported health behaviors between baseline and follow up time points between study interventions.
Change in health behaviors in breast cancer survivors
Change in health behaviors in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Health History Questionnaire, a local questionnaire developed by the study researchers. Participants will report on the following: weekly leisure-time physical activities; weekly consumption of fruits, vegetables, fast food/snacks, caffeine, carbonated beverages; cigarette and alcohol use. Unhealthy behaviors will be reverse scored. Higher scores represent better outcome. Significant change will be indicated by p<.05 on reported health behaviors between baseline and follow up time points between study interventions.

Full Information

First Posted
May 24, 2023
Last Updated
July 6, 2023
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05931874
Brief Title
Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
Acronym
F2TMind
Official Title
Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 5, 2023 (Anticipated)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration. Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks. Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality. Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.
Detailed Description
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration. Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks. Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality. Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA. Research participants will be identified and recruited at Robert H. Lurie Cancer Center (RHLCC) at Northwestern University (NU). All BCS and Buddies will complete an initial 10-15 minute eligibility screening online, over the phone, or in-person. The study RA will obtain informed consent and HIPAA authorization from eligible participants according to IRB approved procedures. Assessments. After informed consent completion, the NU study team will send participants an email with an individual, secure link to study questionnaires and notification that an ActiGraph accelerometer packet has been mailed. Participants will be asked to complete the questionnaire within 1 week of receipt. BCS will be provided with detailed written instructions for how to wear the ActiGraph. Randomization and Study Orientation. After completing baseline assessments, BCS will be randomized to each group using computer-generated randomly permuted blocks. After randomization, the NU study team will send the participant an intervention packet which will include the Fitbit, Fitbit instructions, instructions and a QR code to download the study app, and instructions specific to each condition to which they are assigned. The participant will also be scheduled for an orientation phone or web call with study staff to go over the contents of the intervention packet and expectations of participation for each component in greater detail. Intervention Components Core Intervention (Fitbit + Study App). All participants will receive a low-resource self-monitoring intervention consisting of the Fitbit AltaHR (or similar) and the study self-monitoring app. Participants will be asked to download the Fitbit app and wear the Fitbit 24/7 throughout the 48-week study period. The core study app will support BCS to increase their MVPA. Participants will be provided with a weekly MVPA goal to build efficacy and ensure safe progression towards the overall goal of 150 minutes per week. Participants will be instructed to self-monitor progress towards these goals via feedback on Fitbit Alta HR and the daily, weekly and monthly progress information provided in the study app. Buddy. Participants assigned to this condition will select a buddy of their choice (i.e. friend, co-worker, caregiver or family member) that is ≥ 18 years of age and willing to share their Fitbit data with the study team. The study team will reach out to the buddy via an email containing a description of the expectations of the buddy and a link to complete online screening. The buddy will be mailed a Fitbit, share their Fitbit data with the study team, and be provided with access to, and instructions for, all of the study app modules the participant has access to for their assigned condition. The buddy will be expected to attend a 15-minute group orientation call online and to listen to four 10-15 minute podcasts (one every 3 weeks) during the 24 week intervention. Each webinar will provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support. E-coaching. Participants assigned to this condition will receive a weekly scheduled text message from their coach. Text messages will focus on building self-efficacy and self-regulation skills, setting realistic outcome expectations, overcoming barriers, and problem-solving and will directly support the participant's engagement in the intervention. The coach will provide a brief overview of the participant's recent progress and goals, ask if they are having any barriers and help them troubleshoot and set specific goals for the next week. In addition to the scheduled messaging, participants will also be instructed to reach out to their coach with any questions or for additional assistance. The coach will respond within 24 hours (weekdays) to 48 hours (weekends), maximum. General Mindfulness Training. Participants assigned to this condition will be instructed to watch 1 (1-2 mins), mindfulness education videos each week which lay the foundation for what mindfulness is and how it can be an important health behavior. Each week participants will also be asked to listen to general guided mindfulness audio files ≥5 days/ week. The length of recordings will gradually increase each week from 3-5 to 25-30 minutes. All videos and recording will be available via the study app. MVPA-Specific Mindfulness Training. Participants assigned to the MVPA-specific mindfulness training component will be instructed to watch 1-2 brief (1-2 minute), mindfulness education videos each week which lay the foundation for what mindfulness is and the importance of linking mindful awareness with MVPA. Each week participants will be provided access to MVPA-specific guided mindfulness audio files (e.g., 10-minute treadmill walking meditation, 20-minute bicycling meditation) that they will be asked to listen to during ≥3 MVPA sessions/week. The length and intensity of these audio files will correspond to their progression in the program. All videos and recording will be accessed via the study app. Follow-up. Participants will be instructed to maintain their MVPA during the 24-week follow-up period. They will have access to all materials to which they were assigned to less any direct contact from the study team.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, e-health, physical activity, mindfulness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The four Intervention components that are candidates for inclusion in the optimized intervention, each with 2 possible levels, will be tested in a 24-week intervention with a 24-week follow-up using a MOST approach. The effects of the four individual intervention components and their combinations will be examined via a full factorial experiment. The investigators chose a factorial experimental design because these designs have two characteristics essential to the success of MOST. They: a) separate component effects enabling the estimation of the main effect of each candidate component and interactions between components and b) are more economical compared to alternative designs because they often require substantially fewer subjects to achieve the same power and use less resources. The investigators are using a full factorial experiment with 2^4=16 experimental conditions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exp Condition 1
Arm Type
Experimental
Arm Description
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Arm Title
Exp Condition 2
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
Arm Title
Exp Condition 3
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + E-Coach + Buddy
Arm Title
Exp Condition 4
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + E-Coach
Arm Title
Exp Condition 5
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
Arm Title
Exp Condition 6
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training
Arm Title
Exp Condition 7
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
Arm Title
Exp Condition 8
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training
Arm Title
Exp Condition 9
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + General Mindfulness Training + Buddy
Arm Title
Exp Condition 10
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + General Mindfulness Training
Arm Title
Exp Condition 11
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy
Arm Title
Exp Condition 12
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training
Arm Title
Exp Condition 13
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
Arm Title
Exp Condition 14
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
Arm Title
Exp Condition 15
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention + Buddy
Arm Title
Exp Condition 16
Arm Type
Active Comparator
Arm Description
Research participant receives the Core Intervention
Intervention Type
Behavioral
Intervention Name(s)
Core Intervention
Intervention Description
All participants will receive a low-resource self-monitoring intervention consisting of the Fitbit Alta HR (or similar) and the study self-monitoring app. Participants will be provided with the Fitbit Alta HR. They will be asked to download the Fitbit app and wear the Fitbit 24/7 throughout the study. The Fitbit measures PA intensity, steps, and heart rate, and it syncs directly with the Ftibit app on the smartphone which will ill automatically sync with the study app and provide Fitbit data to the study team in real-time. The core study app will support BCS to increase their MVPA. The app will also contain educational information on MVPA and effective behavior change strategies for building self-efficacy, overcoming barriers, enhancing facilitators, setting realistic outcome expectations, and self-regulatory skill-building (i.e., reviewing progress, goal setting, action-planning and coping with disruptions).
Intervention Type
Behavioral
Intervention Name(s)
E-Coach
Intervention Description
Participants assigned to this condition will receive a weekly scheduled text message from their coach. Text messages will focus on building self-efficacy and self-regulation skills, setting realistic outcome expectations, overcoming barriers, and problem-solving and will directly support the participant's engagement in the intervention. The coach will provide a brief overview of the participant's recent progress and goals, ask if they are having any barriers and help them troubleshoot and set specific goals for the next week. Text message protocols will be informed by the investigators' previous experience using telephone coaching to promote MVPA in cancer survivors. In addition to the scheduled messaging, participants will also be instructed to reach out to their coach with any questions or for additional assistance.
Intervention Type
Behavioral
Intervention Name(s)
Buddy
Intervention Description
Participants assigned to this condition will select a buddy of their choice (i.e. friend, co-worker, caregiver or family member) that is ≥ 18 years of age and willing to share their Fitbit data with the study team. The buddy will be mailed a Fitbit, share their Fitbit data with the study team, and be provided with access to, and instructions for, all of the study app modules the participant has access to for their assigned condition. The study app include a buddy module where the buddy and participant can view each other's progress. The buddy will be expected to attend a 15-30 minute group orientation call and listen to four 10-15 minute podcast (one every 3 weeks) during the first 24 weeks of the intervention. Each webinar will provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support.
Intervention Type
Behavioral
Intervention Name(s)
General Mindfulness Training
Intervention Description
Participants assigned to this condition will be instructed to watch 1 (1-2 mins), mindfulness education videos each week which lay the foundation for what mindfulness is and how it can be an important health behavior. Each week participants will also be asked to listen to general guided mindfulness audio files ≥5 days/ week. The length of recordings will gradually increase each week from 3-5 to 25-30 minutes. All videos and recording will be available via the study app.
Intervention Type
Behavioral
Intervention Name(s)
MVPA-Specific Mindfulness Training
Intervention Description
Participants assigned to the MVPA-specific mindfulness training component will be instructed to watch 1-2 brief (1-2 minute), mindfulness education videos each week which lay the foundation for what mindfulness is and the importance of linking mindful awareness with MVPA. Each week participants will be provided access to MVPA-specific guided mindfulness audio files (e.g., 10-minute treadmill walking meditation, 20-minute bicycling meditation) that they will be asked to listen to during ≥3 MVPA sessions/week. The length and intensity of these audio files will correspond to their progression in the program. All videos and recordings will be accessed via the study app.
Primary Outcome Measure Information:
Title
Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors
Description
Physical activity will be measured at baseline, 24 and 48 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). Minutes of moderate and vigorous physical activity will be used to assess change.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Anxiety in breast cancer survivors
Description
Symptom burden of anxiety will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a.
Time Frame
48 weeks
Title
Depression in breast cancer survivors
Description
Symptom burden of depression will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a.
Time Frame
48 weeks
Title
Fatigue in breast cancer survivors
Description
Symptom burden of fatigue will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Fatigue - Short Form 8a.
Time Frame
48 weeks
Title
Physical Function in breast cancer survivors
Description
Physical function will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v. 1.0 - Physical Function - Short Form 20a.
Time Frame
48 weeks
Title
Sleep Disturbance in breast cancer survivors
Description
Symptom burden of sleep disturbance will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v1.0 - Sleep Disturbance - Short Form 8a.
Time Frame
48 weeks
Title
Sleep Impairment in breast cancer survivors
Description
Symptom burden of sleep disturbance will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a.
Time Frame
48 weeks
Title
Applied Cognition Abilities in breast cancer survivors
Description
Symptom burden on applied cognitive abilities will be measured at baseline, 24 and 48 weeks using the PROMIS v1.0-Applied Cognition-Abilities-Short Form 8a.
Time Frame
48 weeks
Title
Emotional Support in breast cancer survivors
Description
Symptom burden on emotional support will be measured at baseline, 24 and 48 weeks using the PROMIS Item Bank v2.0 - Emotional Support.
Time Frame
48 weeks
Title
Self-Esteem in breast cancer survivors
Description
Symptom burden on self-esteem will be measured at baseline, 24 and 48 weeks using the Rosenberg Self-Esteem Scale. This scale assesses global self-esteem and consists of 10-items asking participants to indicate their level of agreement/disagreement with each statement. Sample items include: "I feel that I'm a person of worth, at least on an equal basis with others;" and "I am able to things as well as most people." Participants respond on a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The minimum value one can score is 10, and the maximum is 50. Higher scores indicate a better outcome.
Time Frame
48 weeks
Title
Social support for exercise in breast cancer survivors
Description
Social support for exercise will be measured at baseline, 24 and 48 weeks using the Social Support for Exercise Scale. This scale assesses support for physical activity received from the following categories: family, friends, and other cancer survivors. Statements are scored on a Likert scale of 1 (never) to 5 (very often) for each of the three categories, with higher scores representing better outcome. The minimum value one can score for each category is 10, and the maximum is 50. The minimum value of the total measure is 30, and the maximum is 150. An additional "does not apply" response option is provided on the measure.
Time Frame
48 weeks
Title
Physical self-perception in breast cancer survivors
Description
Physical Self-Perception will be measured at baseline, 24 and 48 weeks using the Physical Self-Perception Profile-Physical Self-worth Subscale. This instrument used to assess self-esteem relative to several domains of physical functioning in a hierarchical, multidimensional fashion. The instrument contains a general physical self-worth scale (PSW) which subsumes four more specific scales of perceived sport competence (SPORT), physical condition (COND), attractive body (BODY), and strength (STRENGTH), with six items per scale. Participants indicated on a four-point scale the degree to which each item is characteristic or true of them. Responses range from 1 (not at all true) to 4 (completely true), with higher scores representing better outcome. The minimum value one can score is 6, and the maximum is 24.
Time Frame
48 weeks
Title
Enjoyment of Physical Activity in young adult cancer survivors
Description
Enjoyment of Physical Activity will be measured at baseline, 24 and 48 weeks using the Physical Activity Enjoyment Scale. This 18-item scale assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7 point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). Eleven items are negatively worded and seven items are positively worded. After reverse scoring the 11 negatively worded items, an overall enjoyment for physical activity score is determined by summing the items, with a value range of 18-126 being possible. Higher scores indicate higher enjoyment, better outcome.
Time Frame
48 weeks
Title
Leisure Time Physical Activity in breast cancer survivors
Description
Leisure time physical activity will be measured at baseline, 24 and 48 weeks using the Godin Leisure Time Exercise Questionnaire Physical Activity. This is a measure of self-reported physical activity participation. Participants report "times per week" they participate in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and the "average duration each time you exercised (in minutes)" for each of the three activity categories. Weekly minutes of total, light, moderate, and vigorous activity are calculated by multiplying the frequency and time of each activity. This value is divided by 7 to obtain daily averages. The minimum value one can score is 0, and the maximum depends on the number of self-reported minutes of physical activity. Higher scores indicate better outcome.
Time Frame
48 weeks
Title
Confidence in ability to be regularly active in breast cancer survivors
Description
Confidence in ability to be regularly active will be measured at baseline, 24 and 48 weeks using the Exercise Self-Efficacy (EXSE). This short form assesses the participants' beliefs in their ability to be regularly active "for the next 12 weeks" on a scale from 0% (not at all confident) to 100% (completely confident), with higher scores representing better outcome.
Time Frame
48 weeks
Title
Confidence in ability to be regularly active despite common barriers in breast cancer survivors
Description
Confidence in ability to be regularly active despite common barriers will be measured at baseline, 24 and 48 weeks using the Barries Self-Efficacy (BARSE). This scale assesses the beliefs in ability to be regularly active despite common barriers "for the next 12 weeks" on a scale from 0% (not at all confident) to 100% (completely confident), with higher scores representing better outcome.
Time Frame
48 weeks
Title
Exercise goal setting in breast cancer survivors
Description
Exercise goal setting in breast cancer survivors will be measured at baseline, 24 and 48 weeks using the Exercise Goal Setting Scale. This scale assesses exercise goal setting behaviors on a scale from 1 (does not describe) to 5 (describes completely), with higher scores representing better outcome.
Time Frame
48 weeks
Title
Sitting time in breast cancer survivors
Description
Sitting time in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Sitting Time Questionnaire. This questionnaire assesses the amount of hours and minutes spent sitting during weekdays and weekends, with lower scores representing better outcome.
Time Frame
48 weeks
Title
Outcome expectations for exercise in breast cancer survivors
Description
Outcome expectations for exercise in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Outcome Expectations for Exercise_MOEES. This scale assesses the beliefs and expectations about the benefits of regular exercise and physical activity on a scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores representing better outcome.
Time Frame
48 weeks
Title
Mindful Awareness in breast cancer survivors
Description
Mindful awareness of distressing thoughts and images will be measured at baseline, 24 and 48 weeks using the Southampton Mindfulness Questionnaire (SMQ). This 16-item scale measures mindful awareness during distressing thoughts and images. Using a 7-point Likert scale (0=strongly disagree to 6=strongly agree), items reflect the following subscales: mindful observation (4 items), letting go (4 items), non- aversion (4 items), and non-judgment (4 items). The minimum value one can score on any of the subscales is 0, and the maximum is 24. The minimum value of the total measure is 0, and the maximum is 96. The higher scores represent better outcome.
Time Frame
48 weeks
Title
Mindful self-compassion in breast cancer survivors
Description
Mindful self-compassion will be measured at baseline, 24 and 48 weeks using the Self-Compassion Short Form. This short form is a 12-item scale measuring items related to self-kindness, self-judgment, and common humanity. Statements on the Self-Compassion Scale are scored on a Likert scale of 1 (almost never) to 5(almost always). To calculate an overall compassion score - Items representing uncompassionate responses to inadequacy or suffering (the self-judgment, isolation, and over-identification subscales) are reverse-coded only when calculating the overall compassion score. In this way, higher scores represent a lower frequency of these responses.
Time Frame
48 weeks
Title
Post-traumatic growth in breast cancer survivors
Description
Post-traumatic growth will be measured at baseline, 24 and 48 weeks using the Post-traumatic Growth Inventory. This 21-item self-report scale assesses growth or benefits after a specific traumatic life event. The Post Traumatic Growth Inventory (PTGI) is scored by adding all the responses, with higher scores representing better outcome.
Time Frame
48 weeks
Title
Implementation feasibility measured by enrollment rate
Description
This indicator of implementation feasibility for the interventions delivered is defined by the overall enrollment rate being >/= 70% (e.g., total number of individuals enrolled/total number approached). Enrollment rate will be tracked continuously during the 48 week study.
Time Frame
48 weeks
Title
Implementation feasibility measured by retention rate
Description
This indicator of implementation feasibility for the interventions delivered is defined by the retention rate being >/= 70% (e.g., total number of participants who drop out/ total number randomized). Retention rate will be tracked continuously during the 48 weeks of the study and significant differences between the study interventions in the number of participant withdrawals will be tracked.
Time Frame
48 weeks
Title
Adherence to the study app + Fitbit by breast cancer survivors
Description
Adherence to the study app + Fitbit will be monitored and usage tracked continuously during the 48 week study. Objective data include Fitbit wear time, number of times app is opened each week, time spent in app each time it is opened, and for participants who receive each component, usage of general and moderate to vigorous intensity physical activity specific mindfulness videos (i.e. whether clicked, how many times and for how long), number of e-coaching exchanges, number of buddy training webinars attended, and number of buddy interactions in the app.
Time Frame
48 weeks
Title
Acceptability of the technology supported physical activity interventions as measured by a post-intervention evaluation survey
Description
Acceptability will be measured using a brief, Likert-type survey assessing participant enjoyment, satisfaction, perceived benefit, and ease of use. Acceptability is defined as >/= 70% of survey responses in affirmation of this.
Time Frame
48 weeks
Title
Change in body mass index in breast cancer survivors
Description
Change in body mass index in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Health History Questionnaire, a local questionnaire developed by the study researchers. Participants will report on the following: height and most recent weight. BMI will be calculated. Significant change will be indicated by p<.05 on reported health behaviors between baseline and follow up time points between study interventions.
Time Frame
48 weeks
Title
Change in health behaviors in breast cancer survivors
Description
Change in health behaviors in breast cancer survivors will be assessed at baseline, 24 and 48 weeks using the Health History Questionnaire, a local questionnaire developed by the study researchers. Participants will report on the following: weekly leisure-time physical activities; weekly consumption of fruits, vegetables, fast food/snacks, caffeine, carbonated beverages; cigarette and alcohol use. Unhealthy behaviors will be reverse scored. Higher scores represent better outcome. Significant change will be indicated by p<.05 on reported health behaviors between baseline and follow up time points between study interventions.
Time Frame
48 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For BCS Female, age 18 years or older Stage I-III breast cancer diagnosis within the past 5 years Diagnosis of cancer between 18-39 years and within the past 5 years ≥3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies Self-report engagement in <60 min/week of MVPA Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willingness to obtain medical clearance from a primary care physician or oncologist Internet access and smartphone ownership Fluency in spoken and written English Willingness to find a buddy (someone who knows about their cancer and participation in this study and who is willing to participate by supporting them during the 24-week study), if assigned to that condition For "Buddies" Friend, co-worker, caregiver or family member of a participating BCS Age 18 years or older Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willing to obtain medical clearance from a primary care physician Internet access and smartphone ownership Fluency in spoken and written English Willingness to share their Fitbit data with the study team Exclusion Criteria: Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery Currently pregnant or plans to become pregnant Plans to move out of the United States in next 18 months Current enrollment in another dietary or physical activity trial Inability to provide informed consent Prisoners or other detained individuals
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siobhan M Phillips, PhD, MPH
Phone
312-503-4235
Email
smphillips@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bruriah E Horowitz, MEd
Phone
312-503-3465
Email
bruriah.horowitz@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siobhan M Phillips, PhD, MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David E Victorson, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siobhan M Phillips, PhD, MPH
Phone
312-503-4235
Email
smphillips@northwestern.edu
First Name & Middle Initial & Last Name & Degree
David E Victorson, PhD
Phone
847-467-3060
Email
d-victorson@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31184787
Citation
Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019 Sep;69(5):363-385. doi: 10.3322/caac.21565. Epub 2019 Jun 11.
Results Reference
background
PubMed Identifier
20411366
Citation
Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22.
Results Reference
background
PubMed Identifier
16818906
Citation
McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.
Results Reference
background
PubMed Identifier
20052559
Citation
Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6. Erratum In: J Cancer Surviv. 2011 Mar;5(1):112.
Results Reference
background
PubMed Identifier
22570317
Citation
Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM. Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Jun 6;104(11):815-40. doi: 10.1093/jnci/djs207. Epub 2012 May 8.
Results Reference
background
PubMed Identifier
32409489
Citation
Arem H, Mama SK, Duan X, Rowland JH, Bellizzi KM, Ehlers DK. Prevalence of Healthy Behaviors among Cancer Survivors in the United States: How Far Have We Come? Cancer Epidemiol Biomarkers Prev. 2020 Jun;29(6):1179-1187. doi: 10.1158/1055-9965.EPI-19-1318. Epub 2020 May 14.
Results Reference
background
PubMed Identifier
28806753
Citation
Thraen-Borowski KM, Gennuso KP, Cadmus-Bertram L. Accelerometer-derived physical activity and sedentary time by cancer type in the United States. PLoS One. 2017 Aug 14;12(8):e0182554. doi: 10.1371/journal.pone.0182554. eCollection 2017.
Results Reference
background
PubMed Identifier
20582717
Citation
Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Fieuws S, Lefevre J, Philippaerts R, Truijen S, Neven P, Christiaens MR. Physical activity levels after treatment for breast cancer: one-year follow-up. Breast Cancer Res Treat. 2010 Sep;123(2):417-25. doi: 10.1007/s10549-010-0997-6. Epub 2010 Jun 27.
Results Reference
background
PubMed Identifier
22052746
Citation
Charlier C, Van Hoof E, Pauwels E, Lechner L, Spittaels H, De Bourdeaudhuij I. The contribution of general and cancer-related variables in explaining physical activity in a breast cancer population 3 weeks to 6 months post-treatment. Psychooncology. 2013 Jan;22(1):203-11. doi: 10.1002/pon.2079. Epub 2011 Oct 5.
Results Reference
background
PubMed Identifier
12655532
Citation
Irwin ML, Crumley D, McTiernan A, Bernstein L, Baumgartner R, Gilliland FD, Kriska A, Ballard-Barbash R. Physical activity levels before and after a diagnosis of breast carcinoma: the Health, Eating, Activity, and Lifestyle (HEAL) study. Cancer. 2003 Apr 1;97(7):1746-57. doi: 10.1002/cncr.11227.
Results Reference
background
PubMed Identifier
22451113
Citation
Phillips SM, McAuley E. Social cognitive influences on physical activity participation in long-term breast cancer survivors. Psychooncology. 2013 Apr;22(4):783-91. doi: 10.1002/pon.3074. Epub 2012 Mar 26.
Results Reference
background
PubMed Identifier
18274783
Citation
Thorsen L, Courneya KS, Stevinson C, Fossa SD. A systematic review of physical activity in prostate cancer survivors: outcomes, prevalence, and determinants. Support Care Cancer. 2008 Sep;16(9):987-97. doi: 10.1007/s00520-008-0411-7. Epub 2008 Feb 15.
Results Reference
background
PubMed Identifier
19564663
Citation
Stevinson C, Tonkin K, Capstick V, Schepansky A, Ladha AB, Valance JK, Faught W, Steed H, Courneya KS. A population-based study of the determinants of physical activity in ovarian cancer survivors. J Phys Act Health. 2009 May;6(3):339-46. doi: 10.1123/jpah.6.3.339.
Results Reference
background
PubMed Identifier
24989069
Citation
Kampshoff CS, Jansen F, van Mechelen W, May AM, Brug J, Chinapaw MJ, Buffart LM. Determinants of exercise adherence and maintenance among cancer survivors: a systematic review. Int J Behav Nutr Phys Act. 2014 Jul 2;11:80. doi: 10.1186/1479-5868-11-80.
Results Reference
background
PubMed Identifier
28374211
Citation
Valle CG, Tate DF. Engagement of young adult cancer survivors within a Facebook-based physical activity intervention. Transl Behav Med. 2017 Dec;7(4):667-679. doi: 10.1007/s13142-017-0483-3.
Results Reference
background
PubMed Identifier
30468299
Citation
Schneider J, Malinowski P, Watson PM, Lattimore P. The role of mindfulness in physical activity: a systematic review. Obes Rev. 2019 Mar;20(3):448-463. doi: 10.1111/obr.12795. Epub 2018 Nov 23.
Results Reference
background
PubMed Identifier
26812450
Citation
Rabin C, Pinto B, Fava J. Randomized Trial of a Physical Activity and Meditation Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2016 Mar;5(1):41-7. doi: 10.1089/jayao.2015.0033. Epub 2015 Oct 15.
Results Reference
background
PubMed Identifier
25629322
Citation
Courneya KS, Rogers LQ, Campbell KL, Vallance JK, Friedenreich CM. Top 10 research questions related to physical activity and cancer survivorship. Res Q Exerc Sport. 2015 Jun;86(2):107-16. doi: 10.1080/02701367.2015.991265. Epub 2015 Jan 28.
Results Reference
background
Citation
Hedeker D, Gibbons RD, Waternaux C. Sample size estimation for longitudinal designs with attrition: comparing time-related contrasts between two groups. Journal of Educational and Behavioral Statistics. 1999;24(1):70-93.
Results Reference
background
PubMed Identifier
23746267
Citation
Buchholz SW, Wilbur J, Ingram D, Fogg L. Physical activity text messaging interventions in adults: a systematic review. Worldviews Evid Based Nurs. 2013 Aug;10(3):163-73. doi: 10.1111/wvn.12002. Epub 2013 Jun 7.
Results Reference
background
PubMed Identifier
9588623
Citation
Freedson PS, Melanson E, Sirard J. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998 May;30(5):777-81. doi: 10.1097/00005768-199805000-00021.
Results Reference
background
PubMed Identifier
17426327
Citation
Welk GJ, McClain JJ, Eisenmann JC, Wickel EE. Field validation of the MTI Actigraph and BodyMedia armband monitor using the IDEEA monitor. Obesity (Silver Spring). 2007 Apr;15(4):918-28. doi: 10.1038/oby.2007.624.
Results Reference
background
PubMed Identifier
31626055
Citation
Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
Results Reference
background
PubMed Identifier
4053261
Citation
Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
Results Reference
background
PubMed Identifier
17991929
Citation
Garcia SF, Cella D, Clauser SB, Flynn KE, Lad T, Lai JS, Reeve BB, Smith AW, Stone AA, Weinfurt K. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol. 2007 Nov 10;25(32):5106-12. doi: 10.1200/JCO.2007.12.2341. Erratum In: J Clin Oncol. 2008 Feb 20;26(6):1018. Lad, Thomas [added].
Results Reference
background
PubMed Identifier
21697139
Citation
Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.
Results Reference
background
Citation
Lai J-S, Cella D, Choi S, Teresi JA, Hays RD, Stone AA. Developing a fatigue item bank for the Patient-Reported Outcomes Measurement Information System (PROMIS FIB version 1). Presented at the Meeting of the Survey Methods in Multicultural, Multinational, and Multiregional Contexts (3MC), Berlin, Germany. 2008.
Results Reference
background
PubMed Identifier
20550019
Citation
Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.
Results Reference
background
PubMed Identifier
18573227
Citation
Chadwick P, Hember M, Symes J, Peters E, Kuipers E, Dagnan D. Responding mindfully to unpleasant thoughts and images: reliability and validity of the Southampton mindfulness questionnaire (SMQ). Br J Clin Psychol. 2008 Nov;47(Pt 4):451-5. doi: 10.1348/014466508X314891. Epub 2008 Jun 20.
Results Reference
background
PubMed Identifier
21584907
Citation
Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
Results Reference
background
PubMed Identifier
8827649
Citation
Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.
Results Reference
background
PubMed Identifier
8433355
Citation
McAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993 Feb;16(1):103-13. doi: 10.1007/BF00844757.
Results Reference
background
PubMed Identifier
19181688
Citation
Wojcicki TR, White SM, McAuley E. Assessing outcome expectations in older adults: the multidimensional outcome expectations for exercise scale. J Gerontol B Psychol Sci Soc Sci. 2009 Jan;64(1):33-40. doi: 10.1093/geronb/gbn032. Epub 2009 Jan 29.
Results Reference
background
PubMed Identifier
12054320
Citation
Rovniak LS, Anderson ES, Winett RA, Stephens RS. Social cognitive determinants of physical activity in young adults: a prospective structural equation analysis. Ann Behav Med. 2002 Spring;24(2):149-56. doi: 10.1207/S15324796ABM2402_12.
Results Reference
background
PubMed Identifier
3432232
Citation
Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
Results Reference
background
Citation
Rosenberg, M. Society and the adolescent self-image. Princeton, NJ: Princeton University Press.1965.
Results Reference
background
Citation
Fox, K.R., & Corbin, C.B. The physical self-perception profile: Development and preliminary validation. Journal of Sport & Exercise Psychology, 11, 408-430 1989.
Results Reference
background
Citation
Kendzierski D, DeCarlo KJ. Physical Activity Enjoyment Scale: Two validation studies. Journal of Sport & Exercise Psychology. 1991.
Results Reference
background
Citation
Hedeker DR, Gibbons RD. Longitudinal Data Analysis. Hoboken, N.J.: Wiley-Interscience; 2006.
Results Reference
background
PubMed Identifier
21132416
Citation
Collins LM, Baker TB, Mermelstein RJ, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC. The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011 Apr;41(2):208-26. doi: 10.1007/s12160-010-9253-x.
Results Reference
background
PubMed Identifier
16097907
Citation
Collins LM, Murphy SA, Nair VN, Strecher VJ. A strategy for optimizing and evaluating behavioral interventions. Ann Behav Med. 2005 Aug;30(1):65-73. doi: 10.1207/s15324796abm3001_8.
Results Reference
background
Citation
Pinheiro JC, Bates DM. Approximations to the log-likelihood function in the nonlinear mixed-effects model. Journal of Computational and Graphical Statistics. 1995;4(1):12-35.
Results Reference
background
PubMed Identifier
26822111
Citation
Krull JL, MacKinnon DP. Multilevel Modeling of Individual and Group Level Mediated Effects. Multivariate Behav Res. 2001 Apr 1;36(2):249-77. doi: 10.1207/S15327906MBR3602_06.
Results Reference
background
Citation
DiCiccio TJ, Efron B. Bootstrap confidence intervals. Statistical science. 1996:189-212.
Results Reference
background
Citation
Hankin VV, D.; Polster, R. . Maximizing Acceptance and Enrollment in MBSR Randomized Controlled Trials with Older Men Diagnosed with Cancer. . Poster presented to the 8th Annual International Scientific Conference of Mindfulness in Medicine, Health Care, and Society Worcester, MA. 2010.
Results Reference
background
Citation
Victorson D, Du H, Hankin V, et al. Mindfulness-based stress reduction decreases fear of progression over time for men with prostate cancer on active surveillance: results from a randomized clinical trial. J Urol. 2012;187(4S):384.
Results Reference
background
PubMed Identifier
27145355
Citation
Victorson D, Hankin V, Burns J, Weiland R, Maletich C, Sufrin N, Schuette S, Gutierrez B, Brendler C. Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial. Psychooncology. 2017 Aug;26(8):1155-1163. doi: 10.1002/pon.4135. Epub 2016 May 3.
Results Reference
background
Citation
Victorson D, Maletich C, Gutierrez B, Schuette S, Morgan T, Kutikov A, Kundu S, Eggener S, Brendler C. Description of a new national cancer institute funded randomized controlled trial
Results Reference
background
Citation
Victorson D, Garland, E, Hanley, A, Greco, C. Is mindfulness immeasurable? Discovery and dialogue of conceptual, practical, scientific, and experiential solutions. Glob Adv Health Med. 2018 7(1160):13.
Results Reference
background
Citation
Victorson D, Maletich, C, Sufrin, N, Schuette, S, Gutierrez, B, Cordero, E, Johnson, C, Stencel, D, Bakosh, L, Ring, M. Development of a New Clinical Mindfulness Research Tool to Enhance, Deliver and Streamline Online Mindfulness Interventions. J Altern Complement Med. 2016;0(0):A21.
Results Reference
background

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Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors

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