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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a Fitbit to increase daily activity can reduce chronic pain and related stress in breast cancer survivors. Participants will use a fitness tracker and receive guidance from a health coach to enhance their physical activity. Women who have undergone breast surgery for cancer and continue to experience significant pain might be suitable candidates, particularly if they identify as Hispanic or Latinx and currently maintain a low to moderate activity level. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance the quality of life for breast cancer survivors.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it does allow for endocrine therapy and ovarian suppression, so you may be able to continue those treatments.

What prior data suggests that using a Fitbit device is safe for breast cancer survivors?

Research shows that using a Fitbit is generally safe for breast cancer survivors. Fitbits are wearable gadgets that track physical activity, such as step count. Studies have found that most people can use these devices without major issues.

One study discovered that activity trackers like Fitbits helped people become more active after cancer treatment, indicating that the device is not only safe but also useful for encouraging exercise. Another study focused on breast cancer survivors and found they appreciated using Fitbits to track their activity.

In summary, Fitbits are considered safe for breast cancer survivors. They are easy to use, and many people find them helpful for staying active without experiencing major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Fitbits for breast cancer survivors because this approach encourages active participation in managing recovery. Unlike traditional treatments that focus primarily on medical interventions, this method empowers patients by promoting physical activity as part of their daily routine. By using a Fitbit to monitor and increase daily steps and active hours, along with support from health coaches, survivors can potentially improve their overall health and well-being. This hands-on, tech-driven approach offers a personalized way to enhance recovery and quality of life.

What evidence suggests that using a Fitbit tracker is effective for improving physical activity and reducing pain in breast cancer survivors?

Research shows that using a Fitbit, which participants in this trial will use, can help cancer survivors become more active. One study found that patients who used a Fitbit and received counseling became more physically active. Another study showed that Fitbits helped track exercise and sleep during chemotherapy. These devices can make it easier for cancer survivors to stay active, even when it's challenging. Early findings suggest that increased activity can reduce pain and symptoms like stress or depression. ^{1 2 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8199478/

Comparing the Effectiveness of a Wearable Activity Tracker ... Abstract. This randomized controlled trial aimed to compare the effectiveness of a wearable activity tracker (WAT) in addition to counseling (WAT+counseling) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820919302290

Fitbit Usage in Patients With Breast Cancer Undergoing ... This study aimed to determine the utility of using Fitbits to measure physical activity and sleep throughout chemotherapy.

3. cancer.jmir.org cancer.jmir.org/2025/1/e60034

Usability and Implementation Considerations of Fitbit and App ... In cancer survivors, digital health programs can be effective in promoting physical activity and reducing participation barriers [Roberts AL ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0240967

Fitbit wear-time and patterns of activity in cancer survivors ... Fitbit wear-time over the 24-weeks of data was remarkably consistent, with median adherence score of 100% for all weeks. During the intervention ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9068515/

Effect and feasibility of wearable physical activity trackers ... The proportion of patients meeting physical activity guidelines is markedly reduced between pre-diagnosis and during breast cancer treatment (from 60% to 35%) ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/ecc/6692773

“Tracking Health: How Wearable Technology Is ... To examine the use of Fitbits to track patient activity during and up to 6 months after completing chemotherapy for early breast cancer. To ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2095254621000909

Review Effect and feasibility of wearable physical activity ... Our findings show that interventions using physical activity trackers and pedometers are effective at improving physical activity levels following a cancer ...

8. fitabase.com fitabase.com/research-library/

Fitbit Research Library A qualitative evaluation of breast cancer survivors' acceptance of and preferences for consumer wearable technology activity trackers details ...