Mobile Health Exercise Program for Cancer Survivors

Overseen By Zarmina Amin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Disqualifiers: Stage 4 cancer, Metastasis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile health program, using a fitness tracker and an app, can help cancer survivors stay active and improve their quality of life. Participants will receive either just the fitness tracker or both the tracker and a personalized exercise app (mHealth/sFitRx). The trial seeks cancer survivors who completed treatment at least three months ago and are not currently in any other health programs. Participants should own a smartphone and be open to trying a new exercise method. As an unphased trial, this study offers a unique opportunity to explore innovative ways to enhance well-being after cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it does allow continued maintenance immunotherapy or endocrine therapy.

What prior data suggests that this m-health intervention is safe for cancer survivors?

Research shows that mobile health programs, like the one under testing, are generally safe and easy to use. Previous studies with similar tools have shown good results without major safety issues. For instance, one study found that cancer survivors using a similar mobile health program increased their daily steps without negative effects. These apps have also effectively tracked symptoms and health status, with many participants using them regularly. Although this trial doesn't involve direct medical treatment, the technology has a strong safety record in related studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Exercise Program because it leverages modern technology to aid cancer survivors in maintaining physical activity. Unlike traditional rehabilitation programs that often require in-person visits, this program uses a personalized mobile health (mHealth) application called sFitRx, which delivers custom exercise plans right to a participant's smartphone. Coupled with a fitness tracker, it allows users to monitor their activity levels in real-time, making it more engaging and accessible. This innovative approach aims to empower cancer survivors by providing convenient, on-the-go support, potentially leading to better adherence and improved health outcomes compared to conventional methods.

What evidence suggests that this mHealth program is effective for cancer survivors?

Research has shown that mobile health (mHealth) exercise programs, such as the sFitRx app, can improve fitness in cancer survivors. In this trial, participants in the Experimental Group will receive access to the sFitRx app, which provides personalized physical activity programming, along with a fitness tracker to monitor activity levels. One review found that these programs lead to small-to-moderate improvements in heart and lung fitness. Another study demonstrated that personalized exercise plans through mHealth increased the number of daily steps taken by cancer survivors. These findings suggest that using a fitness app with a tracker might help those in recovery become more active and healthier. Participants in the Comparison Group will receive only the fitness tracker. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for cancer survivors leading a sedentary lifestyle who are interested in improving their physical activity and health outcomes. Participants should be comfortable using mobile health technology like fitness trackers.

Inclusion Criteria

I was diagnosed with cancer at an early to mid-stage.

Participant possess basic English communication capability

Participant do not participate in other health promotion programs

Exclusion Criteria

My cancer has spread to distant parts of my body.

My cancer is stage 4.

Participant is already engaging in ≥75 min/week of vigorous-intensity PA, ≥150 min/week of moderate-intensity PA, or an equivalent combination of both over the last 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized mHealth intervention via a fitness wearable and exercise app for 12 months

12 months

Baseline, 6 months, and 12 months assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mHealth/sFitRx

Trial Overview

The study tests if a personalized exercise program delivered through a mobile app (sFitRx) and monitored with a Fitbit Inspire 3 can increase physical activity and improve weight, quality of life, beliefs, and emotions among cancer survivors.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Experimental Group participants would receive access to a study-developed mHealth application, sFitRx, that delivers personalized PA programming as well as be provided with a fitness tracker to monitor their habitual PA levels.

Group II: Comparison Group Active Control 1 Intervention

Comparison Group participants would receive the fitness tracker only.

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

University of Tennessee Medical Center

Collaborator

Trials

7

Recruited

450+

University of Tennessee

Collaborator

Trials

202

Recruited

146,000+

Published Research Related to This Trial

A multi-component mobile health intervention significantly improved daily physical activity and physical health in cancer survivors compared to a control group, with participants increasing their daily steps and overall well-being over a 6-month period.

The social media component of the intervention enhanced perceived social support among cancer survivors, indicating that social interaction can play a beneficial role in their recovery and health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of personalized exercise prescriptions and social media delivered through mobile health on cancer survivors' physical activity and quality of life. Gao, Z., Ryu, S., Zhou, W., et al.[2023]

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 58 publications identified 34 exercise programs for cancer survivors conducted in home or community settings, highlighting the diversity of interventions available.

The review revealed significant gaps in reporting on the implementation processes and contextual factors affecting these programs, indicating a need for more detailed studies to enhance future community-based exercise interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. Neil-Sztramko, SE., Smith-Turchyn, J., Fong, A., 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]

The pilot study involving 7 colorectal cancer survivors showed that a 12-week mHealth home-based exercise intervention was highly feasible, with an 88.6% workout completion rate and 100% retention, indicating strong participant engagement.

Participants reported improved quality of life and expressed a desire for more intense workouts, suggesting that the intervention was not only safe (with no adverse events) but also positively received, particularly the moderate-intensity continuous exercise (MICE) approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of an mHealth, home-based exercise intervention in colorectal cancer survivors: A pilot randomized controlled trial. Moraitis, AM., Rose, NB., Johnson, AF., et al.[2023]

The Fit2Thrive app, designed to promote moderate and vigorous physical activity among breast cancer survivors, showed improved usability and quality scores after iterative testing with two groups of survivors, indicating it is user-friendly and acceptable for this population.

Participants provided positive feedback on various app features, such as self-monitoring and motivational notifications, suggesting that the app has potential to effectively encourage physical activity among breast cancer survivors, although further testing is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centered development of a smartphone application (Fit2Thrive) to promote physical activity in breast cancer survivors. Welch, WA., Solk, P., Auster-Gussman, L., et al.[2022]

Adding behavioral counseling to a 4-week supervised physical activity program for kidney cancer survivors showed feasibility and a potential increase in physical activity levels, although the increase was not statistically significant.

Participants receiving behavioral counseling improved their 6-minute walk distance significantly more than those receiving standard exercise counseling, suggesting that behavioral strategies may enhance fitness outcomes in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of adding behavioral counseling to supervised physical activity in kidney cancer survivors: a randomized controlled trial. Trinh, L., Plotnikoff, RC., Rhodes, RE., et al.[2014]

This pilot study will assess the feasibility of personalized virtual exercise training for 20 breast and prostate cancer survivors over 24 weeks, which includes 12 weeks of one-on-one training followed by 12 weeks of independent exercise using recorded sessions.

The study aims to evaluate the preliminary effects of this virtual program on various health metrics, such as body composition and exercise self-efficacy, potentially addressing barriers to physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. Shirazipour, CH., Ruggieri-Bacani, RM., Lockshon, L., et al.[2023]

Mobile health (mHealth) interventions, especially those including personal contact, have strong evidence for effectively increasing moderate-to-vigorous physical activity among cancer survivors, based on a review of 31 studies.

However, the evidence for mHealth interventions in increasing total activity levels and reducing sedentary behavior remains inconclusive, highlighting the need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Address Physical Activity and Sedentary Behavior in Cancer Survivors: A Systematic Review. Khoo, S., Mohbin, N., Ansari, P., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11381959/

A systematic review and meta‐analysis - PMC

mHealth exercise interventions appear to be associated with small‐to‐moderate improvements in cardiorespiratory fitness for cancer patients and survivors.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2095254623000716

Effects of personalized exercise prescriptions and social ...

The multi-component m-health intervention (personalized exercise prescriptions and social media) significantly increased cancer survivors' daily steps than the ...

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mhealth.jmir.org

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Impact of a 24-Week Mobile App–Based Human Coaching ...

Results: Among 130 breast cancer survivors, 101 (77.7%) and 93 (71.5%) completed the 6-month and 12-month follow-ups, respectively. The mean age ...

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trialx.com

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Mapping the Evidence on the Impact of mHealth ...

All studies contained multiple interventions, including physical activity, tailored information for self-management of the disease, and symptom tracker.

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Effect of an mHealth intervention on physical activity outcomes among young adult cancer survivors: The IMPACT randomized controlled trial.

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Using an mHealth approach to collect patient-generated ...

The Health Share Study aims to utilize mHealth to collect patient-generated health data (PGHD; daily symptoms, momentary physical health status) and develop ...

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Using mHealth Technology to Evaluate Daily Symptom ...

The 41 survivors included in this study had high adherence to symptom reporting (83%) and HRQOL reporting (95%). Variability of daily symptom burden differed ...