Fitness Tracker for Prostate Cancer Survivors
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Live outside U.S, Psychiatric disorder, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This clinical trial studies how well the InBody Band 3 fitness tracker works to improve physical activity, body composition, and quality of life in Black prostate cancer survivors. Prostate cancer is the most common cancer in men and Black men are more likely to be diagnosed with prostate cancer in an advanced stage. Body composition is associated with disease progression, treatment response, and survival in cancer patients. Reducing stress and maintaining healthy levels of physical activity and sleep are important for a healthy body and improving outcomes, however, there is currently little evidence available on the physical activity, stress levels and sleep patterns in this population. Wearable health activity trackers and smart watches are tools that can be used to track physical activity, stress, sleep and body composition and have been shown to have a positive impact in many patient populations. The InBody Band 3 may be an effective method to improve physical activity, body composition and quality of life in Black prostate cancer survivors.
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 data supports the effectiveness of the treatment InBody Band 3 Fitness Tracker for prostate cancer survivors?
Research shows that fitness trackers like the Fitbit are comfortable and easy to use for prostate cancer survivors, and they find value in sharing the data with their healthcare team. Additionally, wearable devices have been shown to improve physical activity and health outcomes in cancer survivors, suggesting potential benefits for prostate cancer survivors using similar devices.
12345Is the InBody Band 3 Fitness Tracker safe for prostate cancer survivors?
Research on similar fitness trackers like Fitbit shows they are generally safe and comfortable for cancer survivors, including those with prostate cancer. Participants found these devices easy to wear, and no significant safety issues were reported.
16789How does the InBody Band 3 Fitness Tracker treatment differ from other treatments for prostate cancer survivors?
The InBody Band 3 Fitness Tracker is unique because it focuses on promoting physical activity through a wearable device, which can be easily integrated into daily life and clinical care. Unlike traditional treatments that may involve medication or surgery, this approach encourages lifestyle changes and provides real-time feedback to help prostate cancer survivors improve their health and quality of life.
17101112Eligibility Criteria
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
Are able to read/speak English and communicate by phone
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
+7 more
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)
+3 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Supportive care (InBody Band 3 fitness tracker)Experimental Treatment3 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in FloridaJacksonville, FL
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Acceptability of Fitbit for physical activity tracking within clinical care among men with prostate cancer. [2022]Prior research has not examined the acceptability of commercially available fitness tracking devices in men with prostate cancer, many of whom are at risk for conditions that physical activity could alleviate. We conducted an exploratory 3-week field study to examine acceptability of the Fitbit Zip and attitudes towards integrating fitness tracking into clinical care among men with prostate cancer. Twenty-six men used the Fitbit Zip for a one-week baseline phase followed by a 2-week optional use phase and then completed in-depth interviews. Interview data was analyzed using inductive thematic analysis. Participants found the device comfortable and easy to wear. Barriers to use included health and technology difficulties. Participants expressed value in sharing Fitbit data with their health care team. Findings support the use of easy to use and simple fitness trackers among men with prostate cancer and there could be opportunities to integrate fitness tracker data into clinical care.
Long-term efficacy of a computer-tailored physical activity intervention for prostate and colorectal cancer patients and survivors: A randomized controlled trial. [2023]Physical activity (PA) can improve the physical and psychological health of prostate and colorectal cancer survivors, but PA behavior change maintenance is necessary for long-term health benefits. OncoActive is a print- and web-based intervention in which prostate and colorectal cancer patients and survivors receive automatically generated, personalized feedback aimed at integrating PA into daily life to increase and maintain PA. We evaluated the long-term outcomes of OncoActive by examining the 12-month follow-up differences between OncoActive and a control group, and we explored whether PA was maintained during a 6-month non-intervention follow-up period.
Facilitators and barriers to participation in lifestyle modification for men with prostate cancer: A scoping review. [2020]Diet and physical activity changes have been shown to improve quality of life and health outcomes for prostate cancer (PC) survivors; however, few survivors make lifestyle changes. We aimed to identify PC-specific facilitators and barriers to dietary and physical activity changes and participation in survivorship-based lifestyle management programmes.
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. [2022]This systematic review and meta-analysis aimed to evaluate the effect of wearable devices for improving physical activity and health-related outcomes in cancer survivors.
A distance-based, randomized controlled trial for reducing sedentary behavior among prostate cancer survivors: a study protocol. [2022]Prostate cancer survivors (PCS) experience long-term side effects beyond treatment such as fatigue, depression and anxiety. Quality and engaging supportive care programs are needed to reduce these chronic and debilitating effects. Independent of physical activity (PA), high volumes of sedentary behavior (SB) are associated with chronic disease-related risk factors and poorer cancer-specific quality of life (QoL). Simultaneously increasing PA and decreasing SB may be an effective health promotion strategy. Given that PCS may face several barriers to engaging in supervised programs, there is a need to develop and assess the efficacy of interventions that employ distance-based approaches for behavior change. The primary aim of this study is to determine the effects of a 12-week intervention (Fitbit + behavioral counselling) vs. Fitbit-only control group in reducing SB among PCS. Secondary outcomes include light-intensity PA, QoL, motivational outcomes, and patient satisfaction.
Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). [2022]Cancer survivors are often sedentary. Self-monitoring may promote physical activity through self-activation. We conducted a pilot trial to evaluate whether wearable activity tracker with personalized text message feedback would increase physical activity.
Use of consumer wearable devices to promote physical activity among breast, prostate, and colorectal cancer survivors: a review of health intervention studies. [2020]A growing amount of research has successfully incorporated Fitbit devices and other wearable activity trackers into technology-oriented lifestyle interventions to increase physical activity among cancer survivors.
An Evaluation of Participant Perspectives and Wear-Time Compliance for a Wrist-Worn Versus Thigh-Worn Accelerometer in Cancer Survivors. [2023]Accelerometers are frequently used to measure free-living physical activity and sleep in cancer survivors. To obtain valid data, participants must adhere to wear-time guidelines; therefore, understanding survivor's preference may be critical when selecting an accelerometer. This study compared cancer survivors' reported discomfort and interference, and wear-time compliance between a wrist-worn accelerometer and a thigh-worn accelerometer.
Systematic Review of Randomized Controlled Trials of Exercise Interventions Using Digital Activity Trackers in Patients With Cancer. [2021]Background: Exercise can ameliorate cancer- and treatment-related toxicities, but poor adherence to exercise regimens is a barrier. Exercise interventions using digital activity trackers (E-DATs) may improve exercise adherence, but data are limited for patients with cancer. We conducted a systematic review examining the feasibility of E-DATs in cancer survivors and effects on activity level, body composition, objective fitness outcomes, health-related quality of life (HRQoL), self-reported symptoms, and biomarkers. Methods: We identified randomized controlled trials (RCTs) of E-DATs in adult cancer survivors published in English between January 1, 2008, and July 27, 2017. Two authors independently reviewed article titles (n=160), removed duplicates (n=50), and reviewed the remaining 110 articles for eligibility. Results: A total of 12 RCTs met eligibility criteria, including 1,450 patients (mean age, 50-70 years) with the following cancers: breast (n=5), colon or breast (n=2), prostate (n=1), acute leukemia (n=1), or others (n=3). Duration of E-DATs ranged from 4 to 24 weeks, and the follow-up period ranged from 4 to 52 weeks, with retention rates of 54% to 95%. The technology component of E-DATs included pedometers (n=8); pedometers with smartphone application (n=1), Wii Fit (n=1), heart rate monitor (n=1); and a wireless sensor with accelerometer, gyroscope, and magnetometer (n=1). Adherence by at least one measure to E-DATs was >70% in 8 of 8 RCTs. Compared with controls, E-DATs significantly improved patients' step count in 3 of 5 RCTs, activity level in 6 of 9 RCTs, and HRQoL in 7 of 9 RCTs (all P≤05), with no significant changes in biomarkers (eg, interleukin 6, tumor necrosis factor α, C-reactive protein, c-peptide, lipid panel) in 3 RCTs. Duration of E-DAT was not significantly correlated with adherence or study retention. Conclusions: This systematic review shows that E-DATs are feasible to implement in cancer survivors. Future research should examine the optimal type, dose, and schedule of E-DATs for cancer survivors.
Internet of things-based lifestyle intervention for prostate cancer patients on androgen deprivation therapy: a prospective, multicenter, randomized trial. [2021]Androgen deprivation therapy (ADT) has several adverse effects including loss of libido, osteoporosis, and metabolic complications. We aim to examine whether the Smart After-Care (SAC) service, an Internet of Things (IoT)-based lifestyle intervention, affects clinical outcomes in prostate cancer (PCa) patients on ADT. A prospective, multicenter, randomized trial including 172 patients randomly assigned to the SAC or control group was conducted. The SAC group was provided with a smartphone application providing a personalized exercise program, daily activity monitoring, and diet counselling. The control group was briefly educated on the exercise program using a paper brochure. The primary endpoint was increase in cardiorespiratory endurance assessed using the 2-minute walking test (2MWT). Secondary endpoints included improved muscle strength (hand grip strength test and 30-second chair stand test), short physical performance battery, body composition, and health-related quality of life (EORTC-QLQ-C30 and PR25). Participants in both groups showed significant improvement in the 2MWT and 30-second chair stand test after 12 weeks of intervention. Greater improvement in the 2MWT was observed in the SAC group than in the control group. Significantly increased body fat ratio was observed in both groups; however, decreased skeletal muscle mass was observed only in the control group. Marginal improvement in skeletal muscle mass was observed over time in the SAC group when compared with that in the control group. Both groups showed improvement in all physical scales in the EORTC-QLQ-C30 questionnaire, and the SAC group showed a significant interaction of group and time for social functioning scales. SAC improved cardiorespiratory endurance, sarcopenic obesity, and health-related quality of life in patients with PCa on ADT.
Barriers and applied activity, quality of life and self-efficacy in prostate cancer survivors 1 year after completing radiotherapy. [2023]The aims of the study were to assess self-reported physical activity (PA) levels, barriers to PA, quality of life and self-efficacy to manage chronic disease of prostate cancer survivor 1 year after radiotherapy treatment.
Physical exercise habits, lifestyle behaviors, and motivation to change among men with prostate cancer: a cross-sectional study. [2022]To describe the physical exercise (PE) habits, lifestyle, and motivation to change toward healthier behaviors in patients newly diagnosed with prostate cancer (PCa).