Mobile Health Exercise Program for Cancer Survivors

Overseen By Suryeon Ryu, 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

Trial Summary

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 data supports the effectiveness of the treatment mHealth/sFitRx for cancer survivors?

Research shows that mobile health interventions, like mHealth/sFitRx, which use wearable devices and personalized exercise plans, can help cancer survivors increase their physical activity and improve their quality of life. These interventions are more effective when they include personal contact components, such as social media support. ^{1 2 3 4 5}

Is the Mobile Health Exercise Program for Cancer Survivors safe for humans?

The studies reviewed suggest that mobile health exercise programs, which often include activity trackers and personalized feedback, are generally safe for cancer survivors. These programs have been tested in various cancer survivor groups and have shown to be feasible and acceptable, with no significant safety concerns reported. ^{1 4 6 7 8}

How is the mHealth/sFitRx treatment different from other treatments for cancer survivors?

The mHealth/sFitRx treatment is unique because it combines personalized exercise prescriptions with mobile health technology, including wearables, apps, and social media, to enhance physical activity and quality of life for cancer survivors. This approach is more comprehensive than traditional exercise programs, which may not integrate technology or personalized elements. ^{1 4 9 10 11}

What is the purpose of this trial?

Participation in regular physical activity is vital to a healthy lifestyle. Research has shown that regular participation in physical activity among cancer survivors is not only able to improve health outcomes, but is also related to their quality of life. As we live in an age of technology, health wearables and smartphone apps might be one novel manner by which to help cancer survivors increase physical activity as well as improve health outcomes. Yet, the effectiveness of wearable and app as a tool for health promotion among cancer survivors is largely unstudied. The purpose of this study is to evaluate the effectiveness of a personalized m-health intervention via fitness wearable (Fitbit Inspire 3) exercise app (sFitRx) on physical activity, weight, quality of life, individual beliefs, and emotions among cancer survivors.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. China 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Leveraging Fitness Tracker and Personalized Exercise Prescription to Promote Breast Cancer Survivors' Health Outcomes: A Feasibility Study. [2020]

3. United States 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. [2014]

4. Switzerland pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Address Physical Activity and Sedentary Behavior in Cancer Survivors: A Systematic Review. [2021]

5. China 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. [2022]

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

Feasibility and acceptability of an mHealth, home-based exercise intervention in colorectal cancer survivors: A pilot randomized controlled trial. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

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

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

User-centered development of a smartphone application (Fit2Thrive) to promote physical activity in breast cancer survivors. [2022]

9. United States 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. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Streaming Web-Based Exercise at Home Study for Breast and Prostate Cancer Survivors: A Feasibility Study Protocol. [2023]

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

A survey of technology literacy and use in cancer survivors from the Alberta Cancer Exercise program. [2022]