Back to resultsOptimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors
Primary Purpose
Breast Cancer Female, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Core
Support Calls
App+
Online gym
App notifications
Buddy
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer Female
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Stage I-III breast cancer within the last 5 years
- Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
- English speaking
- Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
- Own a smartphone
- Have access to a computer with Internet
- Participants may be using adjuvant endocrine therapies.
- Willing to be waitlisted for future wave if current wave reaches capacity
Exclusion Criteria:
-Women will be excluded if they report any of the following:
- Respiratory, joint or cardiovascular problems precluding physical activity
- Metastatic disease
- Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:
- A prior cardiovascular event (i.e. stroke, myocardial infarction)
- Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Arm 22
Arm 23
Arm 24
Arm 25
Arm 26
Arm 27
Arm 28
Arm 29
Arm 30
Arm 31
Arm 32
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Experimental Condition #1
Experimental Condition #2
Experimental Condition #3
Experimental Condition #4
Experimental Condition #5
Experimental Condition #6
Experimental Condition #7
Experimental Condition #8
Experimental Condition #9
Experimental Condition #10
Experimental Condition #11
Experimental Condition #12
Experimental Condition #13
Experimental Condition #14
Experimental Condition #15
Experimental Condition #16
Experimental Condition #17
Experimental Condition #18
Experimental Condition #19
Experimental Condition #20
Experimental Condition #21
Experimental Condition #22
Experimental Condition #23
Experimental Condition #24
Experimental Condition #25
Experimental Condition #26
Experimental Condition #27
Experimental Condition #28
Experimental Condition #29
Experimental Condition #30
Experimental Condition #31
Experimental Condition #32
Arm Description
core, support calls
core, support calls, app+
core, support calls, buddy
core, support calls, online gym
core, support calls, app notifications
core, app+
core, app+, buddy
core, app+, online gym
core, app+, app notifications
core, buddy
core, buddy, online gym
core, buddy, app notifications
core, online gym
core, online gym, app notifications
core, app notifications
core, support calls, app+, buddy
core, support calls, app+, online gym
core, support calls, app+, app notifications
core, support calls, buddy, online gym
core, support calls, buddy, app notifications
core, support calls, online gym, app notifications
core, app+, buddy, online gym
core, app+, buddy, online gym, app notifications
core, support calls, buddy, online gym, app notifications
core, buddy, online gym, app notifications
core, app+, online gym, app notifications
core, support calls, app+, buddy, online gym
core, support calls, app+, buddy, app notifications
core, support calls, app+, online gym, app notifications
core
core, app+, buddy, app notifications
core, support calls, app+, buddy, online gym, app notifications
Outcomes
Primary Outcome Measures
Adherence to a 12 Week Technology Supported Physical Activity Intervention
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
Participant Retention
Percentage of participants retained at the end of the 12 week intervention of those randomized [(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized*100].
Intervention Reach
Percentage of individuals randomized of those who were sent a study screening survey
Secondary Outcome Measures
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
Physical activity will be measured at baseline and at 12 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).
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
Physical activity will be measured at baseline and at 24 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).
Change in Fatigue From Before to After a 12-Week Intervention
Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Change in Physical Function From Before to After a 12-Week Intervention
Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off.
Change in Depression From Before to After a 12-Week Intervention
Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Change in Depression From Pre-Intervention to 24-week Follow-up
Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Adherence to During the Full 24-Week Study Period
Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24.
Participant Retention at 24 Week Follow-up
Percentage of participants retained at 24 weeks of those randomized
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol.
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects.
Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better.
Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better.
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better.
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better.
Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better.
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Full Information
NCT ID
NCT03131440
First Posted
April 18, 2017
Last Updated
February 13, 2023
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03131440
Brief Title
Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors
Official Title
Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
June 17, 2019 (Actual)
Study Completion Date
June 17, 2019 (Actual)
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
No
5. Study Description
Brief Summary
The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Physical Activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Condition #1
Arm Type
Experimental
Arm Description
core, support calls
Arm Title
Experimental Condition #2
Arm Type
Experimental
Arm Description
core, support calls, app+
Arm Title
Experimental Condition #3
Arm Type
Experimental
Arm Description
core, support calls, buddy
Arm Title
Experimental Condition #4
Arm Type
Experimental
Arm Description
core, support calls, online gym
Arm Title
Experimental Condition #5
Arm Type
Experimental
Arm Description
core, support calls, app notifications
Arm Title
Experimental Condition #6
Arm Type
Experimental
Arm Description
core, app+
Arm Title
Experimental Condition #7
Arm Type
Experimental
Arm Description
core, app+, buddy
Arm Title
Experimental Condition #8
Arm Type
Experimental
Arm Description
core, app+, online gym
Arm Title
Experimental Condition #9
Arm Type
Experimental
Arm Description
core, app+, app notifications
Arm Title
Experimental Condition #10
Arm Type
Experimental
Arm Description
core, buddy
Arm Title
Experimental Condition #11
Arm Type
Experimental
Arm Description
core, buddy, online gym
Arm Title
Experimental Condition #12
Arm Type
Experimental
Arm Description
core, buddy, app notifications
Arm Title
Experimental Condition #13
Arm Type
Experimental
Arm Description
core, online gym
Arm Title
Experimental Condition #14
Arm Type
Experimental
Arm Description
core, online gym, app notifications
Arm Title
Experimental Condition #15
Arm Type
Experimental
Arm Description
core, app notifications
Arm Title
Experimental Condition #16
Arm Type
Experimental
Arm Description
core, support calls, app+, buddy
Arm Title
Experimental Condition #17
Arm Type
Experimental
Arm Description
core, support calls, app+, online gym
Arm Title
Experimental Condition #18
Arm Type
Experimental
Arm Description
core, support calls, app+, app notifications
Arm Title
Experimental Condition #19
Arm Type
Experimental
Arm Description
core, support calls, buddy, online gym
Arm Title
Experimental Condition #20
Arm Type
Experimental
Arm Description
core, support calls, buddy, app notifications
Arm Title
Experimental Condition #21
Arm Type
Experimental
Arm Description
core, support calls, online gym, app notifications
Arm Title
Experimental Condition #22
Arm Type
Experimental
Arm Description
core, app+, buddy, online gym
Arm Title
Experimental Condition #23
Arm Type
Experimental
Arm Description
core, app+, buddy, online gym, app notifications
Arm Title
Experimental Condition #24
Arm Type
Experimental
Arm Description
core, support calls, buddy, online gym, app notifications
Arm Title
Experimental Condition #25
Arm Type
Experimental
Arm Description
core, buddy, online gym, app notifications
Arm Title
Experimental Condition #26
Arm Type
Experimental
Arm Description
core, app+, online gym, app notifications
Arm Title
Experimental Condition #27
Arm Type
Experimental
Arm Description
core, support calls, app+, buddy, online gym
Arm Title
Experimental Condition #28
Arm Type
Experimental
Arm Description
core, support calls, app+, buddy, app notifications
Arm Title
Experimental Condition #29
Arm Type
Experimental
Arm Description
core, support calls, app+, online gym, app notifications
Arm Title
Experimental Condition #30
Arm Type
Experimental
Arm Description
core
Arm Title
Experimental Condition #31
Arm Type
Experimental
Arm Description
core, app+, buddy, app notifications
Arm Title
Experimental Condition #32
Arm Type
Experimental
Arm Description
core, support calls, app+, buddy, online gym, app notifications
Intervention Type
Behavioral
Intervention Name(s)
Core
Intervention Description
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Intervention Type
Behavioral
Intervention Name(s)
Support Calls
Intervention Description
Participants will receive 6 bi-weekly phone calls from study staff.
Intervention Type
Behavioral
Intervention Name(s)
App+
Intervention Description
Participants will receive "deluxe" version of smartphone app with additional features.
Intervention Type
Behavioral
Intervention Name(s)
Online gym
Intervention Description
Participants will receive access to online exercise videos.
Intervention Type
Behavioral
Intervention Name(s)
App notifications
Intervention Description
Participants will receive motivational app notifications
Intervention Type
Behavioral
Intervention Name(s)
Buddy
Intervention Description
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Primary Outcome Measure Information:
Title
Adherence to a 12 Week Technology Supported Physical Activity Intervention
Description
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
Time Frame
12 weeks
Title
Participant Retention
Description
Percentage of participants retained at the end of the 12 week intervention of those randomized [(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized*100].
Time Frame
12 weeks
Title
Intervention Reach
Description
Percentage of individuals randomized of those who were sent a study screening survey
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
Description
Physical activity will be measured at baseline and at 12 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).
Time Frame
Change from baseline to 12 weeks
Title
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
Description
Physical activity will be measured at baseline and at 24 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).
Time Frame
Change from baseline to 24 weeks
Title
Change in Fatigue From Before to After a 12-Week Intervention
Description
Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time Frame
Change from baseline to 12 weeks
Title
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
Description
Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time Frame
Change from baseline to 24 weeks
Title
Change in Physical Function From Before to After a 12-Week Intervention
Description
Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time Frame
Change from baseline to 12 weeks
Title
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
Description
Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off.
Time Frame
Change from baseline to 24 weeks
Title
Change in Depression From Before to After a 12-Week Intervention
Description
Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time Frame
Change from baseline to 12 weeks
Title
Change in Depression From Pre-Intervention to 24-week Follow-up
Description
Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time Frame
Change from baseline to 24 weeks
Title
Adherence to During the Full 24-Week Study Period
Description
Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24.
Time Frame
24 weeks
Title
Participant Retention at 24 Week Follow-up
Description
Percentage of participants retained at 24 weeks of those randomized
Time Frame
24 weeks
Title
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
Description
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol.
Time Frame
Change from baseline to 12 weeks
Title
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
Description
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Time Frame
Change from baseline to 24 weeks
Title
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
Description
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Time Frame
Change from baseline to 12 weeks
Title
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
Description
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects.
Time Frame
Change from baseline to 24 weeks
Title
Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
Description
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better.
Time Frame
Change from baseline to 12 weeks
Title
Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
Description
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better.
Time Frame
Change from baseline to 24 weeks
Title
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
Description
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better.
Time Frame
Change from baseline to 12 weeks
Title
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
Description
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better.
Time Frame
Change from baseline to 24 weeks
Title
Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
Description
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time Frame
Change from baseline to 12 weeks
Title
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
Description
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better.
Time Frame
Change from baseline to 24 weeks
Title
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
Description
Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time Frame
Change from baseline to 12 weeks
Title
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
Description
Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time Frame
Change from baseline to 24 weeks
Title
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
Description
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time Frame
Change from baseline to 12 weeks
Title
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
Description
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time Frame
Change from baseline to 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Stage I-III breast cancer within the last 5 years
Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
English speaking
Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
Own a smartphone
Have access to a computer with Internet
Participants may be using adjuvant endocrine therapies.
Willing to be waitlisted for future wave if current wave reaches capacity
Exclusion Criteria:
-Women will be excluded if they report any of the following:
Respiratory, joint or cardiovascular problems precluding physical activity
Metastatic disease
Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:
A prior cardiovascular event (i.e. stroke, myocardial infarction)
Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy.
Learn more about this trial
Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors
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