Back to resultsA Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Core Exercise Promotion Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer
- <60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months
- Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods
- Willing to wear the ActiGraph monitor during assessment periods
- Access to internet to complete REDCap survey assessments
Exclusion Criteria:
- Non-English speaking/not able to read English
- Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
- Currently pregnant
- History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
- Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8)
- Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6-item cognitive screener)
- Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener
Sites / Locations
- Dartmouth-Hitchcock Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Affect-regulated exercise prescription
Arm Description
Participants receive instructions to adjust their pace of exercise so that they feel "fairly good" or better (i.e., a rating of +1 or higher on the Feeling Scale) while exercising and to avoid any increases in intensity that promote feeling "fairly bad" or worse. If no intensity of exercise feels at least "fairly good" participants will be told to exercise at an intensity that feels "as positive as possible."
Outcomes
Primary Outcome Measures
Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure
A 4-item self-report questionnaire used to measure acceptability of the affect-regulated exercise prescription using a Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 - 16. Higher scores indicate greater acceptability.
Percentage of Sample With Valid Accelerometer Data at Baseline
The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up
The number of participants with valid accelerometer data out of the total number of participants in the sample during the 2-week follow-up assessment, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up
The number of participants with valid accelerometer data out of the total number of participants in the sample during the 6-week follow-up assessment, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up
The number of participants with valid accelerometer data out of the total number of participants in the sample during the 12-week follow-up assessment, multiplied by 100%.
Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion
The percentage of ecological momentary assessment (EMA) survey prompts completed by participants during the study out of the total number of EMA survey prompts delivered to participants.
Number of Participants Who Completed the Exit Interview
Semi-structured interview to assess participants' perceptions regarding their experience participating in the study.
Secondary Outcome Measures
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up
The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire
An 8-item self-report questionnaire used to assess participant satisfaction with study participation using a Likert scale ranging from 1 to 4 . Scores are summed and then averaged; total scores range from 1- 4. Higher scores indicate greater satisfaction.
Study Retention at 2-weeks Follow-up
Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.
Study Retention at 6-weeks Follow-up
Number of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.
Study Retention at 12-weeks Follow-up
Number of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.
Full Information
NCT ID
NCT04903249
First Posted
May 23, 2021
Last Updated
July 7, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04903249
Brief Title
A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation
Official Title
Increasing Physical Activity Among Breast Cancer Survivors: Use of the ORBIT Model to Refine and Test a Novel Approach to Exercise Promotion Based on Affect-regulation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
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 purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Affect-regulated exercise prescription
Arm Type
Experimental
Arm Description
Participants receive instructions to adjust their pace of exercise so that they feel "fairly good" or better (i.e., a rating of +1 or higher on the Feeling Scale) while exercising and to avoid any increases in intensity that promote feeling "fairly bad" or worse. If no intensity of exercise feels at least "fairly good" participants will be told to exercise at an intensity that feels "as positive as possible."
Intervention Type
Behavioral
Intervention Name(s)
Core Exercise Promotion Intervention
Intervention Description
Participants are instructed to increase weekly time spent exercising to >90 minutes over 12 weeks. Exercise will be defined as "activities that use large muscle groups, increase heart rate and breathing rate, and are performed intentionally for the purpose of exercise (as opposed to physical activities of daily living, e.g., housework). Participants complete a videoconferencing visit with the study team and are given task and safety related information pertaining to exercise for survivors of cancer. Participants engage in exercise-related goal-setting and action planning and are provided activity trackers to monitor their activity levels over the 12-week study period.
Primary Outcome Measure Information:
Title
Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure
Description
A 4-item self-report questionnaire used to measure acceptability of the affect-regulated exercise prescription using a Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 - 16. Higher scores indicate greater acceptability.
Time Frame
12-weeks follow-up assessment
Title
Percentage of Sample With Valid Accelerometer Data at Baseline
Description
The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.
Time Frame
Baseline assessment
Title
Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up
Description
The number of participants with valid accelerometer data out of the total number of participants in the sample during the 2-week follow-up assessment, multiplied by 100%.
Time Frame
2-weeks follow-up assessment
Title
Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up
Description
The number of participants with valid accelerometer data out of the total number of participants in the sample during the 6-week follow-up assessment, multiplied by 100%.
Time Frame
6-weeks follow-up assessment
Title
Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up
Description
The number of participants with valid accelerometer data out of the total number of participants in the sample during the 12-week follow-up assessment, multiplied by 100%.
Time Frame
12-weeks follow-up assessment
Title
Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion
Description
The percentage of ecological momentary assessment (EMA) survey prompts completed by participants during the study out of the total number of EMA survey prompts delivered to participants.
Time Frame
Baseline through 12-weeks follow-up assessments
Title
Number of Participants Who Completed the Exit Interview
Description
Semi-structured interview to assess participants' perceptions regarding their experience participating in the study.
Time Frame
12-weeks follow-up assessment
Secondary Outcome Measure Information:
Title
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up
Description
The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Time Frame
12-weeks follow-up assessment
Title
Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire
Description
An 8-item self-report questionnaire used to assess participant satisfaction with study participation using a Likert scale ranging from 1 to 4 . Scores are summed and then averaged; total scores range from 1- 4. Higher scores indicate greater satisfaction.
Time Frame
12-weeks follow-up assessment
Title
Study Retention at 2-weeks Follow-up
Description
Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.
Time Frame
2-weeks follow-up assessment
Title
Study Retention at 6-weeks Follow-up
Description
Number of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.
Time Frame
6-weeks follow-up assessment
Title
Study Retention at 12-weeks Follow-up
Description
Number of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.
Time Frame
12-weeks follow-up assessment
Other Pre-specified Outcome Measures:
Title
Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a
Description
An 8-item self-report measure with response options ranging from 1 (not at all) to 5 (very much) and fatigue interference ranging from 1 (never) to 5 (always) over the past 7 days. Total scores range from 8 - 40. Higher scores reflect more fatigue.
Time Frame
Baseline and 12-weeks follow-up assessments
Title
Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale
Description
A 10-item self-report measure with response options ranging from 1 (poor/never/not at all) to 5 (excellent/completely/always) for items 1-9 and 0 (no pain) to 10 (worst pain imaginable) for the item 10. Total scores range from 9 - 45. Higher scores represent better health-related quality of life.
Time Frame
Baseline and 12-weeks follow-up assessments
Title
Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a
Description
An 8-item self-report measure with response options ranging from 1 (unable to do) to 5 (without any difficulty) and the degree to which health limits specific activities on a scale from 1 (cannot do) to 5 (not at all). Total scores range from 8 - 40. Higher scores reflect better physical function.
Time Frame
Baseline and 12-weeks follow-up assessments
Title
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 2 Weeks Follow up
Description
The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.
Time Frame
2-weeks follow-up assessment
Title
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 6 Weeks Follow up
Description
The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.
Time Frame
6-weeks follow-up assessment
Title
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 12 Weeks Follow up
Description
The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.
Time Frame
12-weeks follow-up assessment
Title
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up
Description
The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Time Frame
2-weeks follow-up assessment
Title
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up
Description
The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Time Frame
6-weeks follow-up assessment
Title
Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire
Description
A 6-item self-report measure of exercise performed over the last month and week. Two items range from 1 (never) to 7 (often) and four items range from 0 (0 days per week) to 7 (7 days per week). Total scores range from 2-21. Higher scores reflect higher levels of voluntary exercise behavior.
Time Frame
Baseline and 12-weeks follow-up assessments
Title
Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)
Description
A single item self-report measure that present six statements describing various levels of monthly physical activity. Response options range from 1 (I did not do much physical activity) to 5 (I did vigorous activities almost daily). Total scores range from 1-5. Higher scores reflect more vigorous, more frequent physical activities completed in the past month.
Time Frame
Baseline and 12-weeks follow-up assessments
Title
Change in Intentions to Engage in Physical Activity Measured Using The Exercise Intentions Scale
Description
A 5-item self-report measure of intentions to engage in physical activity. Response options range from 1 (not at all likely) to 7 (very likely). Responses are summed and then averaged; total scores range from 1-7. Higher scores represent stronger intentions to engage in physical activity.
Time Frame
Baseline and 12-weeks follow-up assessments
Title
Change in Self-efficacy for Exercise Measured Using The Barriers Specific Self-Efficacy for Exercise Scale
Description
A 13-item self-report measure of one's perceived capability to exercise regularly despite commonly identified barriers to participation. Response options range from 0 (not at all confident) to 100 (highly confident). Responses are summed and then averaged; total scores range from 0% - 100%, higher scores represent greater self-efficacy for exercise.
Time Frame
Baseline and 12-weeks follow-up assessments
Title
Change in Intrinsic Motivation for Exercise Measured Using The Behavioral Regulations in Exercise Questionnaire (BREQ-2)
Description
A 4-item self-report scale depicting intrinsic motivation for exercise. Response options range from 0 (not true for me) to 4 (very true for me). Responses are summed and then averaged; total scores range from 0-4. Higher scores indicate greater intrinsic motivation for exercise.
Time Frame
Baseline and 12-weeks follow-up assessments
Title
Change in Affective Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale
Description
A 4-item self-report measure of affective attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable affective attitudes about exercise.
Time Frame
Baseline and 12-weeks follow-up assessments
Title
Change in Instrumental Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale
Description
A 4-item self-report measure of instrumental attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable instrumental attitudes about exercise.
Time Frame
Baseline and 12-weeks follow-up assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer
<60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months
Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods
Willing to wear the ActiGraph monitor during assessment periods
Access to internet to complete REDCap survey assessments
Exclusion Criteria:
Non-English speaking/not able to read English
Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
Currently pregnant
History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8)
Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6-item cognitive screener)
Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney J Stevens, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Clinic
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation
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