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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app and a Fitbit can improve recovery after major surgeries for gastrointestinal (GI) cancers, such as those in the stomach or colon. Researchers seek to discover if these tools can prevent hospital readmissions. Participants will either use the app and Fitbit alongside their usual care or follow standard care alone, which may include treatments like Botulinum toxin injections, Anticholinergics, Baclofen, Levodopa, or Deep Brain Stimulation. This trial suits English-speaking adults who own a smartphone and are scheduled for GI cancer surgery. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance recovery for future patients.

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 prior data suggests that this mobile health technology is safe for colorectal cancer recovery?

Research shows that using mobile health apps and devices, like a Fitbit, is generally safe for most people. One study found that many cancer patients accepted these apps for tracking and managing pain. The app received a high accuracy rating of 0.96 for measuring pain, indicating effective performance.

Another study examined a system using a Fitbit and a smartphone app, finding these tools easy to use and set up. No major safety issues emerged, meaning users did not experience serious problems.

Overall, using a mobile health app and Fitbit appears well-tolerated, with most people experiencing no significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mobile health technology combined with Fitbit for colorectal cancer recovery because it offers a unique way to monitor and encourage physical activity and recovery. Unlike traditional treatment options that mainly focus on medication and surgery, this approach integrates a mobile health app and a wearable device to track mobility data, providing real-time feedback and personalized care. The use of digital tools aims to enhance patient engagement and potentially improve recovery outcomes by encouraging more active lifestyles, which can be crucial for recovery. This innovative method could lead to a more holistic approach to post-surgery care, making the recovery process more interactive and tailored to individual needs.

What evidence suggests that this mobile health technology is effective for colorectal cancer recovery?

Research has shown that mobile health apps and Fitbits, which participants in this trial may receive, can aid recovery from colorectal cancer surgery. In one study, 73.1% of patients using these apps experienced better health outcomes. These apps are particularly effective for tracking and managing pain, with a high accuracy rate of 0.96. Additionally, they encourage participation in important health screenings. Overall, mobile health technology offers promising support for patients recovering from major gastrointestinal cancer surgeries. Meanwhile, another group in this trial will receive standard care, including treatments such as Botulinum toxin injections, Anticholinergics, Baclofen, Levodopa, and Deep Brain Stimulation. ^{1 4 6 7 8}

Who Is on the Research Team?

Heather Yeo, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Your doctor believes that you cannot participate in the study because you have a history of alcohol or drug abuse.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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