Physical Activity for Breast Cancer Survivors

Overseen By Jacklyn M Nemunaitis, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: New Mexico Cancer Care Alliance

Disqualifiers: Metastatic disease, Pregnancy, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 11 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jacklyn M Nemunaitis, MD

Principal Investigator

New Mexico Cancer Research Alliance

Cindy K Blair, Ph.D.

Principal Investigator

New Mexico Cancer Research Alliance

Eligibility Criteria

This trial is for young, Hispanic women who have survived breast cancer and are experiencing chronic pain post-surgery. Participants should be interested in increasing their daily physical activity to potentially improve their pain and overall well-being.

Inclusion Criteria

Baseline low to moderate activity level (exercise less than 120 minutes a week)

Self-identified as Hispanic/Latinx

I had surgery for breast cancer more than 6 months ago.

Exclusion Criteria

Meeting or exceeding physical activity guidelines (> 150 minutes per week of moderate-intensity exercise)

Pregnant women

Prisoners may not participate in this study as this is a study of free-living individuals

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear a Fitbit and use the Fitbit application to monitor their physical activity daily in weeks 2-12, with health coaching calls in weeks 2, 3, 5, 7, 9, and 11

11 weeks

6 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Fitbit

Trial Overview The study is testing if using a Fitbit to track daily activity, along with health coaching, can help reduce chronic pain in participants. It aims to understand the impact of increased physical activity on survivors' mental and social health too.

Participant Groups

Group I: Supportive Care (Fitbit) Experimental Treatment 1 Intervention

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.

Fitbit is already approved in United States, European Union, United Kingdom, Switzerland for the following indications:

Approved in United States as Fitbit for:

• General wellness
• Fitness tracking
• Heart rate monitoring
• Sleep tracking

Approved in European Union as Fitbit for:

• General wellness
• Fitness tracking
• Heart rate monitoring
• Sleep tracking
• Atrial fibrillation detection

Approved in United Kingdom as Fitbit for:

• General wellness
• Fitness tracking
• Heart rate monitoring
• Sleep tracking
• Atrial fibrillation detection

Approved in Switzerland as Fitbit for:

• General wellness
• Fitness tracking
• Heart rate monitoring
• Sleep tracking
• Atrial fibrillation detection

Who Is Running the Clinical Trial?

New Mexico Cancer Care Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

New Mexico Cancer Research Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+