Clinical trial NCT04064892: Physical Activity Intervention for Young Cancer Survivors
Official title: Physical Activity Interventions for Young Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Quality of Life
Physical Activity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Haus of Volta
First posted: 2019-08-22
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Body Image Scale
timeFrame: Baseline to 12 weeks
measure: Female Sexual Function Index
timeFrame: Baseline to 12 weeks
measure: PROMIS Cancer - Fatigue
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: Weiner LS, Nagel S, Su HI, Hurst S, Hartman SJ. A Remotely Delivered, Peer-Led Physical Activity Intervention for Younger Breast Cancer Survivors (Pink Body Spirit): Protocol for a Feasibility Study and Mixed Methods Process Evaluation. JMIR Res Protoc. 2020 Jul 8;9(7):e18420. doi: 10.2196/18420.