Physical Activity Intervention for Young Cancer Survivors

Not Applicable

Completed

• Conditions: Physical Activity; Quality of Life; Breast Cancer
• Interventions: Behavioral: Exercise Intervention

• Registration Number: NCT04064892
• Lead Sponsor: University of California, San Diego

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-22
• Study Start: 2019-09-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-09-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Intervention	Exercise Intervention	Participants will receive a 12-week, individually-tailored, video conference-based physical activity intervention

Primary Outcome Measures

Name	Time	Method
Physical Activity	Baseline to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Female Sexual Function Index	Baseline to 12 weeks	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.
Body Image Scale	Baseline to 12 weeks	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.
PROMIS Cancer - Fatigue	Baseline to 12 weeks	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.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States