Physical Activity for Breast Cancer

(MetS-BC Trial)

Overseen By Manju Daniel, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Pulmonary, CVD, Hypertension, others

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

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, medical clearance is required if you have certain conditions like diabetes, which might suggest some monitoring or adjustments could be needed.

What data supports the effectiveness of the treatment Bollywood-style group dance, Enhanced physical activity monitor (Fitbit watch with mobile App), PAMDance for breast cancer?

Research shows that physical activity, like dance, can improve quality of life and reduce the risk of death for breast cancer patients. Activity trackers, such as Fitbits, help increase physical activity, which is linked to better outcomes after a breast cancer diagnosis. ^{1 2 3 4 5}

Is it safe to use wearable activity monitors like Fitbit for increasing physical activity in cancer survivors?

Research shows that using wearable activity monitors like Fitbit is generally safe and acceptable for cancer survivors. These devices help increase physical activity levels and improve self-awareness without reported safety concerns. ^{6 7 8 9 10}

How is the Bollywood-style group dance and Fitbit treatment for breast cancer unique?

This treatment is unique because it combines Bollywood-style group dance with the use of a Fitbit watch and mobile app to enhance physical activity, offering a fun and engaging way to increase exercise among breast cancer patients. Unlike traditional treatments, this approach uses wearable technology to provide real-time, objective data on physical activity, helping to motivate and track progress. ^{5 6 9 11 12}

What is the purpose of this trial?

This study aims to to improve physical activity and metabolic outcomes for breast cancer prevention in South Asian Indian immigrant women.

Research Team

Manju Daniel, PhD

Principal Investigator

Rush University College of Nursing

Eligibility Criteria

This trial is for first-generation South Asian Indian women aged 40-65 living in the US, without breast cancer but at risk due to low physical activity and metabolic syndrome. Participants must be able to use a Fitbit with an app, join virtual sessions, and have no disabilities that prevent regular exercise.

Inclusion Criteria

Has a computer or mobile device with Internet access

I can speak and understand Hindi.

Owns a smartphone for Fitbit application

Exclusion Criteria

Systolic BP ≥160 and/or diastolic BP ≥100

I haven't had serious heart, lung problems, or walking issues in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 24-week virtual culturally tailored physical activity program, including enhanced physical activity monitoring and/or Bollywood-style group dance

24 weeks

Virtual sessions 2x/week

Follow-up

Participants are monitored for changes in physical activity and metabolic outcomes

4 weeks

Treatment Details

Interventions

• Bollywood-style group dance
• Enhanced physical activity monitor (Fitbit watch with mobile App)
• PAMDance

Trial Overview The study tests if using a Fitbit watch with an app and participating in Bollywood-style dance classes (PAMDance) can boost physical activity and improve metabolic health to help prevent breast cancer.

Participant Groups

Group I: PAMDance Experimental Treatment 1 Intervention

Participants will receive an enhanced physical activity monitor treatment for 6 months which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor (Fitbit watch). In addition, Participants will participate in 60-minute, moderate-intensity Bollywood-style culturally tailored group dance virtual sessions, 2x/week for 6 months.

Group II: Enhanced physical activity monitor which is Fitbit watch with mobile App Experimental Treatment 1 Intervention

Participants will receive an enhanced physical activity monitor treatment for 6 months which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor (Fitbit watch).

Group III: Bollywood-style group dance Experimental Treatment 1 Intervention

Participants will participate in 60-minute, moderate-intensity Bollywood-style culturally tailored group dance virtual sessions, 2x/week for 6 months.

Group IV: Usual care control Active Control 1 Intervention

Participants in the usual care group do not receive any PAM or Dance related intervention.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Findings from Research

In a study of 377 breast cancer survivors, those who received breast cancer-specific print materials and pedometers significantly increased their physical activity (PA) by 89 minutes per week compared to only 30 minutes in the standard recommendation group, highlighting the effectiveness of tailored interventions.

The combined approach of using both print materials and pedometers not only increased PA but also improved quality of life (QoL) and reduced fatigue, suggesting that personalized strategies can enhance overall well-being in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. Vallance, JK., Courneya, KS., Plotnikoff, RC., et al.[2022]

Wearable activity monitors, like ActiGraph accelerometers and Fitbits, are generally accepted and effective tools for increasing physical activity levels among cancer survivors, as shown in a review of 28 studies involving both active treatment and post-treatment individuals.

While these devices successfully motivate short-term increases in physical activity, the benefits tend to decrease over time, highlighting the need for further research to enhance the long-term sustainability of these technologies in supporting ongoing physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Wearable Activity-Monitoring Technologies to Promote Physical Activity in Cancer Survivors: Challenges and Opportunities for Improved Cancer Care. Keats, MR., Yu, X., Sweeney Magee, M., et al.[2023]

Cancer survivors using wearable activity trackers, like Fitbits, have shown an increase in physical activity, which is important for reducing negative effects from cancer treatments and improving overall health outcomes.

The review identified 13 relevant studies, including 8 randomized controlled trials, indicating a need for further research to better understand how these devices can effectively promote physical activity and weight management in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of consumer wearable devices to promote physical activity among breast, prostate, and colorectal cancer survivors: a review of health intervention studies. Coughlin, SS., Caplan, LS., Stone, R.[2020]

In a pilot study involving 30 cancer patients, the use of a wearable activity tracker combined with personalized text message feedback led to 39% of participants increasing their daily steps by at least 20% over 3 months.

The intervention was well-received, with 72% of participants continuing to use the activity tracker at least 4 days a week after 6 months, suggesting it may effectively promote physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Koontz, BF., Levine, E., McSherry, F., et al.[2022]

Wearable activity monitors are increasingly utilized in oncology trials to provide objective data on physical activity, with 41 trials identified, primarily involving cancer survivors and breast cancer patients.

These monitors can help assess daily activity levels, revealing that cancer survivors take between 4660 and 11,000 steps per day, while those undergoing treatment take 2885 to 8300 steps, indicating a need for further standardization in data collection and analysis to enhance clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable activity monitors in oncology trials: Current use of an emerging technology. Gresham, G., Schrack, J., Gresham, LM., et al.[2019]

Commercially available physical activity monitors offer oncologists a reliable way to objectively measure physical activity in cancer patients, overcoming the biases of self-reporting and short testing durations.

While these devices have been validated for use in various chronic conditions, further research is needed to fully understand their unique benefits and limitations in oncology, allowing for better integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promise of Wearable Physical Activity Monitors in Oncology Practice. Beg, MS., Gupta, A., Stewart, T., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. [2022]

2. England pubmed.ncbi.nlm.nih.gov

"My Body, My Rhythm, My Voice": a community dance pilot intervention engaging breast cancer survivors in physical activity in a middle-income country. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Physical activity during and after adjuvant chemotherapy in patients with breast cancer. [2013]

4. Scotland pubmed.ncbi.nlm.nih.gov

Using a cultural dance program to increase sustainable physical activity for breast cancer survivors-A pilot study. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Breast Cancer Survivors' Experiences With an Activity Tracker Integrated Into a Supervised Exercise Program: Qualitative Study. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Wearable Activity-Monitoring Technologies to Promote Physical Activity in Cancer Survivors: Challenges and Opportunities for Improved Cancer Care. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a text message, Fitbit, and coaching intervention on physical activity maintenance among cancer survivors: a randomized control pilot trial. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Continuous, objective measurement of physical activity during chemotherapy for breast cancer: the Activity in Treatment pilot study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Use of consumer wearable devices to promote physical activity among breast, prostate, and colorectal cancer survivors: a review of health intervention studies. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Wearable activity monitors in oncology trials: Current use of an emerging technology. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Promise of Wearable Physical Activity Monitors in Oncology Practice. [2018]