Trials / Active Not Recruiting
Active Not RecruitingNCT06260332
Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors
Move Toward Recovery: A Physical Activity Intervention to Reduce Persistent Pain Following Breast Surgery for Cancer in Young, Hispanic Women
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- New Mexico Cancer Research Alliance · Academic / Other
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors.
Detailed description
PRIMARY OBJECTIVE: I. To assess the feasibility of a physical activity intervention in young, Hispanic women with chronic post-operative pain after breast surgery for invasive breast cancer, termed post breast surgery pain syndrome (PBSPS) for this study. SECONDARY OBJECTIVES: I. To assess the preliminary efficacy of a physical activity intervention in decreasing pain in young, Hispanic women with PBSPS. II. To assess the preliminary efficacy of the physical activity intervention in increasing physical activity and improving health-related quality of life (hrQOL). OUTLINE: Patients wear a Fitbit and use the Fitbit application to monitor their physical activity daily in weeks 2-12 with the goal of increasing their number of steps per day and their number of active hours per day. Starting at week 2, patients also receive educational materials and attend 6 calls over 20-60 minutes each with their health coach in weeks 2, 3, 5, 7, 9, and 11.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Supportive Care (Fitbit) | Wear Fitbit, Use Fitbit application, Receive educational materials, attend coaching calls, Ancillary studies |
Timeline
- Start date
- 2023-10-20
- Primary completion
- 2024-08-27
- Completion
- 2026-12-31
- First posted
- 2024-02-15
- Last updated
- 2025-10-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06260332. Inclusion in this directory is not an endorsement.