Physical Activity for Breast Cancer

(MetS-BC Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to boost physical activity and improve health markers to help prevent breast cancer in South Asian Indian immigrant women. Participants will try different methods, such as wearing a Fitbit with a mobile app (enhanced physical activity monitor), joining Bollywood-style dance classes (PAMDance), or a combination of both. Women who identify as first-generation South Asian Indian, have not been diagnosed with breast cancer, are currently not very active, and are comfortable with technology are well-suited for this trial. As an unphased trial, it offers a unique opportunity to explore innovative methods to enhance health and prevent breast cancer.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that Bollywood-style group dance boosted health and mental well-being for cancer patients. Participants felt more social and confident, and no serious side effects occurred.

Research has shown that wearable activity trackers, like a Fitbit, can help cancer patients increase physical activity and improve health. These devices monitor fitness levels and are generally safe, with no major issues reported.

Specific safety data for the PAMDance program, which combines dance and wearable technology, is not available. However, since both dance and activity trackers are safe individually, this combination is likely well-tolerated.

Overall, these activities appear to be safe ways to increase physical activity and improve health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for breast cancer because they offer a fun and engaging way to encourage physical activity, which is crucial for recovery and overall health. Unlike traditional methods like chemotherapy and radiation, these treatments focus on enhancing lifestyle through innovative approaches such as Bollywood-style group dance sessions and using enhanced physical activity monitors like Fitbits. The Bollywood dance sessions provide a culturally tailored and enjoyable exercise option, while the Fitbit integration helps participants set goals and track their progress, making it easier to stay motivated. These unique features may help improve adherence to physical activity, offering a supportive and lively alternative to more conventional exercise regimens.

What evidence suggests that this trial's treatments could be effective for breast cancer prevention?

Research has shown that Bollywood-style group dance, one of the treatments in this trial, can enhance physical health, mental well-being, and social connections. Dancing positively influences hormones, self-confidence, and social interaction. Similarly, using a fitness tracker, like a Fitbit, which participants in another arm of this trial will use, encourages more activity, improving quality of life and potentially lowering breast cancer risks. Studies indicate that increased physical activity in breast cancer survivors is linked to a lower risk of cancer and better overall health. Combining dance and activity tracking, as in the PAMDance arm of this trial, could offer the benefits of increased physical activity and improved mental health. ^{1 2 4 6 7}

Who Is on the Research Team?

Manju Daniel, PhD

Principal Investigator

Rush University College of Nursing

Are You a Good Fit for This Trial?

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

Owns a smartphone for Fitbit application

Willing to participate in recorded Virtual intervention sessions

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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, 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06827704

Physical Activity Targeting Metabolic Syndrome for ... This study aims to to improve physical activity and metabolic outcomes for breast cancer prevention in South Asian Indian immigrant women. Detailed Description.

2. mdpi.com mdpi.com/2673-396X/2/4/42

Dance and Music for Improving Health among Patients with ... Dance and music have been shown to induce positive effects on hormonal glands, patients' sociality, and self-confidence.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11234514/

Experiences and Perceived Benefits of Remotely Delivered ... A 6-week virtual, synchronous DMT program aiming to improve physical health, address mental distress, and foster social connection for cancer patients.

4. web.usm.my web.usm.my/km/earlyView_May2021/15_KM-OA-06-20-0122.R1.pdf

An Ethnographic Study on Candy Girls Breast Cancer ... This study intends to examine a breast cancer survivor group called the Candy. Girls. Candy Girls comprises 26-30 women (aged between 40 and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6905195/

Using a Cultural Dance Program to Increase Sustainable ... We conducted a pilot aerobic dance intervention study with a group-based Hula Dance program to increase physical activity for sedentary breast cancer survivors.

6. breastcancertrials.org breastcancertrials.org/bct_nation/browse_trials.seam?filterCategory=PREVENTION&pageRecord=0&cid=1575

Browse Trials - BreastCancerTrials.org Dance Program to Improve Physical Health and Reduce the Risk of Breast Cancer for South Asian Indian Immigrant Women. Physical Activity Targeting Metabolic ...

7. cinj.org cinj.org/celebration-life-through-bollywood-dance-and-music

A Celebration of Life Through Bollywood Dance and Music The most common cancers that affect this group are breast, prostate, colorectal and ovarian. CINJ and the SKN Foundation are working together to improve cancer ...