Mobile Health Technology for Colorectal Cancer Recovery

Overseen By Ananya Sen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Dementia, Emergent surgery, Sepsis, Alcohol/drug abuse

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

107 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Mobile health application and Fitbit for colorectal cancer recovery?

Research shows that using Fitbit devices and other wearable activity trackers can help increase physical activity among cancer survivors, including those with colorectal cancer. This suggests that incorporating these technologies into recovery plans may support better health outcomes by encouraging more physical activity. ^{1 2 3 4 5}

Is using a Fitbit safe for cancer survivors?

Research shows that Fitbit devices are generally safe and comfortable for cancer survivors to use, with no major safety concerns reported. However, some users may find it challenging to remember to charge and wear the device consistently. ^{1 5 6 7 8}

How is the Mobile Health Technology for Colorectal Cancer Recovery treatment different from other treatments?

This treatment is unique because it uses a mobile health app and Fitbit to remotely monitor and support patients after colorectal cancer surgery, focusing on increasing physical activity and improving recovery through technology, unlike traditional treatments that may not incorporate digital tools. ^{1 5 9 10 11}

What is the purpose of this trial?

This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.

Research Team

Heather Yeo, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for English-speaking adults over 18 who own a smartphone and are scheduled for GI cancer surgery (pancreatic, liver, stomach, small bowel, colon or rectal). It's not suitable for those with dementia, substance abuse issues, sepsis from another source or needing emergency surgery.

Inclusion Criteria

I am scheduled for surgery for a GI cancer.

You have a smartphone.

Exclusion Criteria

My doctor says I can't finish the study because of my dementia.

I am currently suffering from sepsis caused by another condition.

I am scheduled for urgent surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either standard care or use of a mobile app and Fitbit to track physical activity and health status

4 weeks

Ongoing monitoring via app

Follow-up

Participants are monitored for readmission rates, patient satisfaction, and return to baseline function

4 weeks

Treatment Details

Interventions

• Mobile health application and Fitbit
• Standard of care

Trial Overview The study compares the effectiveness of using mobile health apps and Fitbit alongside standard care versus standard care alone in preventing hospital readmission after major GI cancer surgeries.

Participant Groups

Group I: Standard of care Experimental Treatment 1 Intervention

Participants will receive standard of care

Group II: Mobile app and Fitbit + Standard of care Active Control 1 Intervention

Mobile health application and Fitbit + standard of care: Participants will utilize mobile app and Fitbit and standard of care. Mobility data will be generated using a mobile health tracker designed for smartphone devices.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Damon Runyon Cancer Research Foundation

Collaborator

Trials

10

Recruited

1,100+

Findings from Research

A study involving 23 colorectal and endometrial cancer survivors revealed that prioritizing physical activity (PA) significantly influenced their engagement and success in changing their PA behavior, with commitment being a key factor.

The use of a Fitbit as a health coach was identified as a crucial element of the intervention, suggesting that wearable technology can effectively promote physical activity by helping individuals monitor their progress and stay accountable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences and facilitators of physical activity engagement amongst colorectal and endometrial cancer survivors: the Wearable Activity Technology and Action-Planning (WATAAP) trial. Hardcastle, SJ., Douglass, E., Wilson, B., et al.[2023]

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]

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 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]

Among adolescent survivors of childhood cancer, only 30.6% consistently used the Fitbit Flex for physical activity tracking in the first 12 weeks, indicating low initial engagement without incentives or reminders.

Despite some positive feedback on self-monitoring and leading a more active lifestyle, overall usage declined significantly over a year, suggesting that additional strategies are needed to maintain interest and engagement with wearable activity trackers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Fitbit Use in Adolescent Survivors of Pediatric Cancer: Who Consistently Uses It and for How Long? Williamson Lewis, R., Howell, KE., Effinger, KE., et al.[2023]

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]

A digital monitoring application was developed through collaborative design with patients and health professionals to support colorectal cancer patients during the first 30 days post-surgery, aiming to improve patient care and outcomes.

The app allows patients to report concerns to healthcare providers, which can help in early identification of issues, reduce readmission rates, and enhance recovery experiences by providing timely support and relevant information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery. Miller, M., Roxburgh, CS., McCann, L., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Experiences and facilitators of physical activity engagement amongst colorectal and endometrial cancer survivors: the Wearable Activity Technology and Action-Planning (WATAAP) trial. [2023]

2. 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]

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

Cancer Patients' Perception of Usefulness of Wearable Exercise Trackers. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of WATAAP to promote physical activity in colorectal and endometrial cancer survivors. [2020]

5. United States 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. [2020]

6. United States 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. [2023]

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

Feasibility of Fitbit Use in Adolescent Survivors of Pediatric Cancer: Who Consistently Uses It and for How Long? [2023]

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

Acceptability of Fitbit for physical activity tracking within clinical care among men with prostate cancer. [2022]

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

Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Exploring colorectal cancer survivors' perspectives on improving care delivery and the role of e-health technology: a qualitative study. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Effects of behavioral change techniques on diet and physical activity in colorectal cancer patients: a systematic review and meta-analysis. [2022]