Fitness Tracker for Prostate Cancer Survivors

No longer recruiting at 1 trial location

Overseen By Sarah Gifford

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Live outside U.S, Psychiatric disorder, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the InBody Band 3 fitness tracker can help Black prostate cancer survivors improve physical activity, body composition, and overall quality of life. The study aims to determine if tracking steps, stress, and sleep with this wearable device positively impacts health and wellness. It targets Black men who have had prostate cancer, are not undergoing intensive cancer treatment, and wish to increase their physical activity. Participants will wear the tracker and participate in weekly check-ins for six weeks. This research might provide insights into better health management post-cancer. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-cancer health management.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, you cannot be undergoing certain cancer therapies like chemotherapy or radiation during the study, except for specific oral or hormonal treatments.

What prior data suggests that the InBody Band 3 fitness tracker is safe for Black prostate cancer survivors?

Research has shown that wearable health trackers, such as the InBody Band 3, are generally easy to use. Various groups have used these devices to monitor and improve physical activity, body composition, and overall well-being. Designed for continuous wear, the InBody Band 3 is comfortable and safe for everyday use.

As this trial focuses on a fitness tracker, it is important to note that these devices typically do not cause serious side effects. Some users might experience minor issues, such as skin irritation where the band contacts the skin, but these are rare and easily managed. Overall, fitness trackers like the InBody Band 3 are considered safe, making them a low-risk choice for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The InBody Band 3 fitness tracker is unique because it offers a new, tech-driven approach to supporting prostate cancer survivors. Unlike traditional treatments that may focus on medication or therapy, this tracker encourages patients to engage in regular physical activity and self-monitoring, which can enhance overall health and well-being. Researchers are excited about this method because it emphasizes patient empowerment and proactive health management through continuous monitoring and weekly goal-setting discussions. This could lead to improved quality of life and potentially better long-term health outcomes for survivors.

What evidence suggests that the InBody Band 3 is effective for improving physical activity, body composition, and quality of life in Black prostate cancer survivors?

Studies have shown that wearable health trackers, such as the InBody Band 3, which participants in this trial will use, can enhance physical activity, body composition, and quality of life. These devices track steps, sleep, and stress, motivating users to remain active and healthy. Research indicates that staying active and maintaining a healthy body composition is crucial for cancer survivors, as it can influence their response to treatment and recovery. Early findings suggest that fitness trackers can lead to better health outcomes, particularly for high-risk groups, such as Black prostate cancer survivors. These devices provide a simple way to monitor and potentially improve health daily. ^{1 2 6 7 8}

Who Is on the Research Team?

Emma Fortune Ngufor, PhD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for Black prostate cancer survivors to see if the InBody Band 3 fitness tracker can help improve their physical activity, body composition, and quality of life. Participants should be willing to use the device and share data on their activity levels, stress, sleep patterns, and body composition.

Inclusion Criteria

Own and are willing to use a personal smartphone with regular/reliable access to the internet to sync regularly with a fitness tracker

Self-identify as Black

I have an email I check regularly for surveys.

Exclusion Criteria

Have a self-reported history of a psychiatric disorder(s) or moderate to severe cognitive impairment precluding participation in the study intervention or preventing the ability to provide independent informed consent

I spend most of my day in bed.

Live outside of the United States (U.S)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the InBody Band 3 fitness tracker continuously and participate in weekly check-in/goal-setting discussions

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in acceptability and adherence rates

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• InBody Band 3 Fitness Tracker

Trial Overview The study is testing whether using the InBody Band 3 fitness tracker encourages better health habits in Black prostate cancer survivors. It involves discussions with researchers, answering questionnaires, and regular usage of this medical device to monitor various health metrics.

How Is the Trial Designed?

Group I: Supportive care (InBody Band 3 fitness tracker) Experimental Treatment 3 Interventions

Patients wear the InBody Band 3 fitness tracker continuously and participate in check-in/goal-setting discussions over 20-30 minutes weekly for 6 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Digital activity trackers (E-DATs) are feasible for use in cancer survivors, with adherence rates exceeding 70% in most studies, indicating that these tools can help patients stick to exercise regimens.

E-DATs significantly improved step counts, activity levels, and health-related quality of life (HRQoL) in cancer survivors compared to control groups, although they did not show significant changes in certain biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Randomized Controlled Trials of Exercise Interventions Using Digital Activity Trackers in Patients With Cancer. Schaffer, K., Panneerselvam, N., Loh, KP., et al.[2021]

In a study involving 52 cancer survivors, no significant differences were found in discomfort, interference, or wear-time compliance between a wrist-worn accelerometer (Actiwatch-2) and a thigh-worn accelerometer (activPAL) over a 7-day period.

Qualitative feedback indicated that while participants reported more interferences with the wrist device, they found the thigh device to be more comfortable, suggesting that user preferences may influence adherence to wear-time guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Participant Perspectives and Wear-Time Compliance for a Wrist-Worn Versus Thigh-Worn Accelerometer in Cancer Survivors. Hidde, MC., Crisafio, ME., Gomes, E., et al.[2023]

A scoping review of 16 studies identified key barriers for prostate cancer survivors in making lifestyle changes, including a perceived lack of evidence for dietary guidelines, treatment side effects, and time constraints.

Facilitators for lifestyle changes included support from health professionals and family, viewing diagnosis as a motivation for change, and using lifestyle adjustments as coping strategies to manage side effects and enhance well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to participation in lifestyle modification for men with prostate cancer: A scoping review. Yannitsos, D., Murphy, RA., Pollock, P., et al.[2020]

A 3-week study involving 26 men with prostate cancer found that the Fitbit Zip was generally accepted, with participants finding it comfortable and easy to wear.

Participants expressed interest in sharing their fitness tracking data with healthcare providers, indicating potential for integrating such devices into clinical care to support physical activity and health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of Fitbit for physical activity tracking within clinical care among men with prostate cancer. Rosenberg, D., Kadokura, EA., Bouldin, ED., et al.[2022]

Prostate cancer survivors one year after radiotherapy reported low levels of physical activity and had a poorer perception of the benefits of exercise compared to age-matched healthy men, indicating a need for targeted interventions to encourage physical activity in this population.

The study, which included 120 participants, also found that prostate cancer survivors had lower quality of life and self-efficacy in managing their chronic disease, suggesting that support systems may be necessary to improve their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and applied activity, quality of life and self-efficacy in prostate cancer survivors 1 year after completing radiotherapy. Martín-Núñez, J., Linares-Moya, M., Calvache-Mateo, A., 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]

A systematic review of 35 trials involving cancer survivors showed that wearable devices, particularly pedometers and Fitbits, significantly improve physical activity levels and health-related outcomes, with moderate-to-large effect sizes (SMD range 0.54-0.87).

Participants using wearable devices reported better quality of life, increased aerobic fitness, improved physical function, and reduced fatigue compared to those receiving usual care, indicating these devices are effective tools for enhancing recovery in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and feasibility of wearable physical activity trackers and pedometers for increasing physical activity and improving health outcomes in cancer survivors: A systematic review and meta-analysis. Singh, B., Zopf, EM., Howden, EJ.[2022]

This study aims to evaluate a 12-week intervention combining Fitbit use and behavioral counseling to reduce sedentary behavior and increase light-intensity physical activity among prostate cancer survivors, with 120 participants recruited across Canada.

The intervention is designed to help participants gradually increase their daily step counts by 3,000 steps above their baseline, potentially improving their quality of life and health outcomes by addressing the long-term side effects of prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A distance-based, randomized controlled trial for reducing sedentary behavior among prostate cancer survivors: a study protocol. Trinh, L., Sabiston, CM., Alibhai, SMH., et al.[2022]

The Smart After-Care (SAC) service, an IoT-based lifestyle intervention, significantly improved cardiorespiratory endurance in prostate cancer patients undergoing androgen deprivation therapy (ADT), as evidenced by greater increases in the 2-minute walking test compared to the control group.

Patients in the SAC group also showed marginal improvements in skeletal muscle mass and better health-related quality of life, particularly in social functioning, while the control group experienced a decrease in skeletal muscle mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet of things-based lifestyle intervention for prostate cancer patients on androgen deprivation therapy: a prospective, multicenter, randomized trial. Park, YH., Lee, JI., Lee, JY., et al.[2021]

A study of 40 Italian men newly diagnosed with prostate cancer revealed that while 65% reported being physically active, over half did not meet recommended exercise levels, indicating a need for improved physical activity among this group.

Despite many participants being aware of their unhealthy habits, such as high alcohol consumption and being overweight, most were unwilling to change their lifestyle, highlighting the importance of healthcare professionals to encourage motivation for healthier behaviors during this critical time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise habits, lifestyle behaviors, and motivation to change among men with prostate cancer: a cross-sectional study. Bressi, B., Iotti, C., Cagliari, M., et al.[2022]

The OncoActive intervention, which provided personalized physical activity feedback to prostate and colorectal cancer survivors, did not show significant long-term differences in physical activity levels compared to a control group at the 12-month follow-up, although self-reported days of physical activity were higher in the OncoActive group.

Participants in the OncoActive group experienced significantly lower fatigue levels compared to the control group at 12 months, suggesting that the intervention may help improve certain health-related outcomes even if physical activity levels did not differ significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy of a computer-tailored physical activity intervention for prostate and colorectal cancer patients and survivors: A randomized controlled trial. Golsteijn, RHJ., Bolman, C., Peels, DA., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06703996

NCT06703996 | InBody Band 3 Fitness Tracker to Improve ... The InBody Band 3 may be an effective method to improve physical activity, body composition and quality of life in Black prostate cancer survivors. Detailed ...

2. withpower.com withpower.com/trial/fitness-tracker-for-prostate-cancer-survivors-9caa6

Fitness Tracker for Prostate Cancer Survivors The InBody Band 3 may be an effective method to improve physical activity, body composition and quality of life in Black prostate cancer survivors. Show more.

3. app.trialscreen.org app.trialscreen.org/trials/inbody-band-3-fitness-tracker-to-improve-health-outcomes-quality-life-trial-nct06703996

InBody Band 3 Fitness Tracker to Improve Health Outcomes and ... Benefits: Participation in this study may help improve physical activity, body composition, and overall quality of life for Black prostate cancer survivors. The ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT06703996

InBody Band 3 Fitness Tracker to Improve Health Outcomes ... InBody Band 3 Fitness Tracker to Improve Health Outcomes and Quality of Life in Black Prostate Cancer Survivors ... data collection weeks for each participant.

5. clinconnect.io clinconnect.io/trials/NCT06703996

InBody Band 3 Fitness Tracker to Improve Health Outcomes This clinical trial is exploring how the InBody Band 3 fitness tracker can help improve the health and quality of life for Black men who have survived prostate ...

6. smartpatients.com smartpatients.com/trials/NCT06703996

InBody Band 3 Fitness Tracker to Improve Health ... The InBody Band 3 may be an effective method to improve physical activity, body composition and quality of life in Black prostate cancer ...

7. trial.medpath.com trial.medpath.com/clinical-trial/1731f5d52d473a4a/nct06703996-digital-divide-wearables-health-outcomes-black-prostate-cancer

InBody Band 3 Fitness Tracker to Improve Health Outcomes ... The InBody Band 3 may be an effective method to improve physical activity, body composition and quality of life in Black prostate cancer survivors. Detailed ...

8. shop.inbodyusa.com shop.inbodyusa.com/products/band3

InBody BAND 3 Go far beyond steps with the InBody BAND 3. Its new double frequencies make it possible to get an accurate InBody Test anywhere!