Physical Activity Intervention for Young Cancer Survivors

Study Overview
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Brief Summary
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The proposed mixed methods pilot study will enroll 20 young breast cancer survivors into a 12-week technology-based, remotely-delivered, peer-moderated physical activity program to examine the effects of the intervention on objectively measured physical activity and multiple aspects of quality of life; and conduct qualitative analyses to refine the intervention for a future randomized controlled trial.

Detailed Description
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Young breast cancer survivors (i.e. those < 50 years old) have lower survival rates than their older counterparts and experience unique physical and mental challenges associated with their cancer treatments. Depression, anxiety, and poor body image are common in young breast cancer survivors. Research in older breast cancer survivors has shown that physical activity can decrease cancer recurrence and mortality, and improve many aspects of quality of life. Few physical activity intervention studies have been conducted in young breast cancer survivors, despite the fact that young survivors would be best served by age-specific interventions designed to target their needs. Remotely-delivered, technology-based interventions may be important to help young breast cancer survivors overcome unique barriers to increasing physical activity and improving quality of life. The study aims are: 1) Explore the feasibility and acceptability of a technology-based, remotely-delivered, peer-moderated physical activity intervention for young breast cancer survivors; 2a) Assess the invention's impact on change in physical activity; and 2b) Measure the intervention's effect on multiple aspects of quality of life

Official Title
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Physical Activity Interventions for Young Cancer Survivors

Conditions
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Breast Cancer, Quality of Life, Physical Activity

Intervention / Treatment
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* Behavioral: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with breast cancer between 18-49 years old Completed active treatment (chemotherapy, radiation) at least 6 months prior to enrollment Self-report low levels of moderate to vigorous physical activity each week Accessible by phone or video chat Have a Fitbit compatible cellphone, tablet, or laptop with Internet Exclusion Criteria: medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention currently pregnant unable to commit to intervention schedule prisoner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Participants will receive a 12-week, individually-tailored, video conference-based physical activity intervention | Behavioral: Exercise Intervention<br>* The intervention will use peer mentors, motivational interviewing, and technology (Fitbit, Fitbit Coach App, & Fitbit message board) to support behavior change. All participants will receive phone or video calls from their peer mentors every other week, and interact with their peer mentor and other participants through a private Fitbit message board at least weekly. Peer mentors will use Fitbit data to identify participants who need additional support to increase their activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | The ActiGraph GT3X+ accelerometer will be used to measure change in minutes of moderate to vigorous physical activity from baseline to 12 weeks. For 7 days around each assessment time point, participants will wear the accelerometer. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Image Scale | The Body Image Scale will be used to measure changes in perceptions of body image from baseline to 12 weeks. Scores range from 0 to 30. A higher score indicates more distress. | Baseline to 12 weeks | 
| Female Sexual Function Index | The Female Sexual Function Index will be used to measure change in self-reported sexual functioning from baseline to 12 weeks. Scores range from 2 to 36. A higher score indicates fewer problems with sexual functioning. | Baseline to 12 weeks | 
| PROMIS Cancer - Fatigue | Change in fatigue from baseline to 12 weeks will be assessed via a Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive test (CAT), PROMIS Cancer- Fatigue. CAT items are dynamically selected for administration from an item bank based upon the respondent's previous answers. Participants will complete 4-12 items. This measure yields a T-Score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of fatigue. | Baseline to 12 weeks |