Evaluation of an Internet-based Physical Activity Program in Combination with Social Support and Mindfulness Training to Promote Physical Activity in Breast Cancer Survivors
This clinical trial tests how well an internet-based physical activity intervention using the using the Fit2ThriveMIND smartphone application (app) in combination with social support and emotion-regulated promoting practices such as mindfulness training works to improve physical activity in breast cancer survivors (BCS). Increased moderate to vigorous intensity physical activity (MVPA) is consistently associated with enhanced quality of life (QOL), reduced cancer treatment related side effects and chronic disease risk, and improved cancer prognosis in BCS. However, up to 90% of breast cancer survivors do not meet MVPA recommendations (i.e. 150 minutes/week). Researchers want to find out which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in BCS.
Inclusion Criteria
- BREAST CANCER SURVIVORS: Female, age 18 years or older
- BREAST CANCER SURVIVORS: Stage I-III breast cancer diagnosis within the past 5 years
- BREAST CANCER SURVIVORS: Diagnosis of cancer between 18-39 years and within the past 5 years
- BREAST CANCER SURVIVORS: ≥ 3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies
- BREAST CANCER SURVIVORS: Self-report engagement in < 60 min/week of MVPA
- BREAST CANCER SURVIVORS: Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q) or willingness to obtain medical clearance from a primary care physician or oncologist
- BREAST CANCER SURVIVORS: Internet access and smartphone ownership
- BREAST CANCER SURVIVORS: Fluency in spoken and written English
- BREAST CANCER SURVIVORS: 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 6-month study), if assigned to that condition
- BUDDIES: Friend, co-worker, caregiver or family member of a participating BCS
- BUDDIES: Age 18 years or older
- BUDDIES: Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q) or willing to obtain medical clearance from a primary care physician
- BUDDIES: Internet access and smartphone ownership
- BUDDIES: Fluency in spoken and written English
- BUDDIES: 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05931874.
Locations matching your search criteria
United States
Illinois
Chicago
PRIMARY OBJECTIVES:
I. To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 6 and 12 months.
II. 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 in other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality.
III. 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.
OUTLINE: Patients wear an Actigraph accelerometer 24/7 for 7 consecutive days on study. Patients are then randomized to 1 of 16 conditions.
CONDITION I: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive weekly text message support from the study coach to provide encouragement and support to achieve individual physical activity goals. Patients also select a buddy of choice for support for 12 months. Buddies receive access to the Fit2ThriveMIND self-monitoring app and wear the Fitbit Charge4 (or similar) 24/7 over 12 months and attend 4, 30-45 minute webinars for information on how to provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support once every 3 weeks for 12 weeks. Patients receive access to mindfulness education videos and watch 1, 1-2 minute video each week. Patients also listen to >= 5 general guided mindfulness audio files and the length of recordings will gradually increase from 3-5 to 25-30 minutes. Additionally, patients watch 1-2 additional mindfulness education videos per week and receive access to MVPA-specific guided mindfulness audio files to listen to >= 3 of the prescribed MVPA sessions per week.
CONDITION II: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive weekly text message support from the study coach to provide encouragement and support to achieve individual physical activity goals. Patients receive access to mindfulness education videos and watch 1, 1-2 minute video each week. Patients also listen to >= 5 general guided mindfulness audio files and the length of recordings will gradually increase from 3-5 to 25-30 minutes. Additionally, patients watch 1-2 additional mindfulness education videos per week and receive access to MVPA-specific guided mindfulness audio files to listen to >= 3 of the prescribed MVPA sessions per week.
CONDITION III: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive weekly text message support from the study coach to provide encouragement and support to achieve individual physical activity goals. Patients also select a buddy of choice for support for 12 months. Buddies receive access to the Fit2ThriveMIND self-monitoring app and wear the Fitbit Charge4 (or similar) 24/7 over 12 months and attend 4, 30-45 minute webinars for information on how to provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support once every 3 weeks for 12 weeks.
CONDITION IV: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive weekly text message support from the study coach to provide encouragement and support to achieve individual physical activity goals.
CONDITION V: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive weekly text message support from the study coach to provide encouragement and support to achieve individual physical activity goals. Patients also select a buddy of choice for support for 12 months. Buddies receive access to the Fit2ThriveMIND self-monitoring app and wear the Fitbit Charge4 (or similar) 24/7 over 12 months and attend 4, 30-45 minute webinars for information on how to provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support once every 3 weeks for 12 weeks. Patients receive access to mindfulness education videos and watch 1, 1-2 minute video each week. Patients also listen to >= 5 general guided mindfulness audio files and the length of recordings will gradually increase from 3-5 to 25-30 minutes.
CONDITION VI: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive weekly text message support from the study coach to provide encouragement and support to achieve individual physical activity goals. Patients receive access to mindfulness education videos and watch 1, 1-2 minute video each week. Patients also listen to >= 5 general guided mindfulness audio files and the length of recordings will gradually increase from 3-5 to 25-30 minutes.
CONDITION VII: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive weekly text message support from the study coach to provide encouragement and support to achieve individual physical activity goals. Patients also select a buddy of choice for support for 12 months. Buddies receive access to the Fit2ThriveMIND self-monitoring app and wear the Fitbit Charge4 (or similar) 24/7 over 12 months and attend 4, 30-45 minute webinars for information on how to provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support once every 3 weeks for 12 weeks. Patients watch 1-2 mindfulness education videos per week and receive access to MVPA-specific guided mindfulness audio files to listen to >= 3 of the prescribed MVPA sessions per week.
CONDITION VIII: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive weekly text message support from the study coach to provide encouragement and support to achieve individual physical activity goals. Patients watch 1-2 mindfulness education videos per week and receive access to MVPA-specific guided mindfulness audio files to listen to >= 3 of the prescribed MVPA sessions per week.
CONDITION IX: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients also select a buddy of choice for support for 12 months. Buddies receive access to the Fit2ThriveMIND self-monitoring app and wear the Fitbit Charge4 (or similar) 24/7 over 12 months and attend 4, 30-45 minute webinars for information on how to provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support once every 3 weeks for 12 weeks. Patients receive access to mindfulness education videos and watch 1, 1-2 minute video each week. Patients also listen to >= 5 general guided mindfulness audio files and the length of recordings will gradually increase from 3-5 to 25-30 minutes.
CONDITION X: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive access to mindfulness education videos and watch 1, 1-2 minute video each week. Patients also listen to >= 5 general guided mindfulness audio files and the length of recordings will gradually increase from 3-5 to 25-30 minutes.
CONDITION XI: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients also select a buddy of choice for support for 12 months. Buddies receive access to the Fit2ThriveMIND self-monitoring app and wear the Fitbit Charge4 (or similar) 24/7 over 12 months and attend 4, 30-45 minute webinars for information on how to provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support once every 3 weeks for 12 weeks. Patients watch 1-2 mindfulness education videos per week and receive access to MVPA-specific guided mindfulness audio files to listen to >= 3 of the prescribed MVPA sessions per week.
CONDITION XII: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients watch 1-2 mindfulness education videos per week and receive access to MVPA-specific guided mindfulness audio files to listen to >= 3 of the prescribed MVPA sessions per week.
CONDITION XIII: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients also select a buddy of choice for support for 12 months. Buddies receive access to the Fit2ThriveMIND self-monitoring app and wear the Fitbit Charge4 (or similar) 24/7 over 12 months and attend 4, 30-45 minute webinars for information on how to provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support once every 3 weeks for 12 weeks. Patients receive access to mindfulness education videos and watch 1, 1-2 minute video each week. Patients also listen to >= 5 general guided mindfulness audio files and the length of recordings will gradually increase from 3-5 to 25-30 minutes. Additionally, patients watch 1-2 additional mindfulness education videos per week and receive access to MVPA-specific guided mindfulness audio files to listen to >= 3 of the prescribed MVPA sessions per week.
CONDITION XIV: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients receive access to mindfulness education videos and watch 1, 1-2 minute video each week. Patients also listen to >= 5 general guided mindfulness audio files and the length of recordings will gradually increase from 3-5 to 25-30 minutes. Additionally, patients watch 1-2 additional mindfulness education videos per week and receive access to MVPA-specific guided mindfulness audio files to listen to >= 3 of the prescribed MVPA sessions per week.
CONDITION XV: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months. Patients also select a buddy of choice for support for 12 months. Buddies receive access to the Fit2ThriveMIND self-monitoring app and wear the Fitbit Charge4 (or similar) 24/7 over 12 months and attend 4, 30-45 minute webinars for information on how to provide social support training and peer discussion of challenges and successes in providing BCS with MVPA support once every 3 weeks for 12 weeks.
CONDITION XVI: Patients participate in a self-monitoring intervention consisting of using the Fit2ThriveMIND self-monitoring app that contains educational information on MVPA and effective behavior change strategies specifically tailored to BCS’ need and wear the Fitbit Charge4 (or similar) 24/7 over 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNorthwestern University
Principal InvestigatorSiobhan M. Phillips
- Primary IDNU 22CC05
- Secondary IDsNCI-2023-10038, STU00217129
- ClinicalTrials.gov IDNCT05931874