Mobile Health App for Colorectal Cancer Survivors

Overseen by Roberto M Benzo, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Severe cardiovascular, respiratory, musculoskeletal, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This clinical trial develops and tests a mobile health (mHealth) intervention to improve adherence to lifestyle recommendations in colorectal cancer (CRC) survivors and their family caregivers. The current challenge for cancer survivorship is identifying novel approaches to help adhere to the lifestyle recommendations that have been shown to improve symptom burden, health outcomes, and health-related quality of life (HRQoL). The development of a digital health intervention specifically for CRC survivors and family caregivers may improve adherence to the American Cancer Society Nutrition and Physical Activity Guideline for Cancer Survivors and improve family health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on lifestyle changes and physical activity for colorectal cancer survivors.

What data supports the effectiveness of the treatment MHealth Intervention for colorectal cancer survivors?

Research shows that mobile health (mHealth) apps can help cancer survivors manage their health by improving quality of life, reducing pain and psychological distress, and enhancing sleep and physical activity. These benefits have been observed in various studies involving cancer survivors, including those with colorectal cancer. ^{1 2 3 4 5}

Is the mobile health app safe for colorectal cancer survivors?

The studies on mobile health apps for colorectal cancer survivors focus on their feasibility and acceptability, which suggests they are generally safe to use. However, specific safety data is not detailed in the available research. ^{1 2 5 6 7}

How is the MHealth Intervention treatment different from other treatments for colorectal cancer survivors?

The MHealth Intervention is unique because it uses a mobile health app to help colorectal cancer survivors manage their health through self-management tools and interactive coaching, focusing on improving quality of life and psychological well-being, unlike traditional treatments that may not address these aspects. ^{1 2 7 8 9}

Research Team

Roberto M Benzo, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for colorectal cancer survivors and their family caregivers. It aims to help them follow lifestyle recommendations that can improve symptoms, health outcomes, and quality of life. Specific eligibility criteria are not provided.

Inclusion Criteria

I have been diagnosed with stage I-III colon or rectal cancer.

Patients must own a smartphone with internet access and can receive text messages

Family caregivers must be willing to participate in all aspects of the intervention and in the assessments required for those in the wait-list control condition if applicable

Exclusion Criteria

Patients living outside the United States (US) during the study period

Patients with potential contraindications to exercise based on the PAR-Q, for those unable to obtain physician clearance

Family caregivers must meet the same exclusion criteria as the patients

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Design

Survivor-caregiver dyads and SMEs complete semi-structured interviews and surveys for intervention content, format, and feature design and development

Not specified

1 visit (in-person or virtual)

User-Experience Testing

Dyads complete semi-structured interviews, participate in think-aloud sessions, and complete surveys to test the Healthy Buckeyes app

Not specified

1 visit (in-person or virtual)

Pilot Study

Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, and receive health coaching over 10 weeks

10 weeks

Follow-up

Participants are monitored for usability, acceptability, and adherence to the intervention

4 weeks

Treatment Details

Interventions

• MHealth Intervention (Behavioural Intervention)

Trial Overview The study is testing a mobile health intervention designed to support adherence to nutrition and physical activity guidelines. Participants will engage in interviews, surveys, educational activities, discussions, internet-based interventions, use medical devices and answer questionnaires.

Participant Groups

Group I: Phase III (pilot study) Experimental Treatment 7 Interventions

Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.

Group II: Phase I (design) Active Control 1 Intervention

Survivor-caregiver dyads and SMEs complete semi-structured interview over 60-90 minutes and surveys over 15 minutes for intervention content, format, and feature design and development on study

Group III: Phase II (user-experience testing) Active Control 3 Interventions

Dyads complete semi-structured interview and participate in think-aloud sessions over 60-90 minutes and complete surveys over 15 minutes to test the Healthy Buckeyes app on study.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Interim Chief Executive Officer since 2022

MD, MBA

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Chief Medical Officer since 2018

MD

Findings from Research

A self-management mobile application for colorectal cancer survivors significantly improved self-efficacy, health practices, and quality of life after six weeks of use, as shown by surveys of 39 participants.

The intervention led to specific improvements in emotional functioning and reductions in overall symptoms and fatigue, highlighting the effectiveness of mobile technology in providing social support for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an interactive coaching intervention on quality of life and psychological factors for colorectal cancer survivors: A single group pre and posttest design. Yoon, J., Lee, H., Son, H.[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]

mHealth applications have shown promise in improving pain and fatigue outcomes for cancer survivors, with three out of four studies reporting positive results for pain and four studies indicating improvements in fatigue.

While there is some evidence for benefits in psychological distress and sleep outcomes, the results were mixed, highlighting the need for further development and targeted approaches in mHealth interventions for cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mHealth for self-management in improving pain, psychological distress, fatigue, and sleep in cancer survivors: a systematic review. Hernandez Silva, E., Lawler, S., Langbecker, D.[2020]

A pilot trial involving 50 breast and colorectal cancer survivors showed that adding a 12-week technology-based physical activity module to standard care significantly improved physical health, mental health, sleep quality, and exercise self-efficacy.

The intervention led to moderate-to-large effect sizes in various health-related quality of life measures, suggesting that integrating technology into survivorship care plans could effectively support cancer survivors' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a technology-supported physical activity intervention on health-related quality of life, sleep, and processes of behavior change in cancer survivors: A randomized controlled trial. Rastogi, S., Tevaarwerk, AJ., Sesto, M., et al.[2021]

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]

The pilot study showed that a digital health intervention using Fitbit devices and SMS text messages is feasible for increasing physical activity in colorectal cancer patients during chemotherapy, with a high follow-up rate of 91% and good adherence to the Fitbit (80% of study days).

Participants expressed high satisfaction with the intervention, particularly with the Fitbit, but indicated a need for more personalized SMS content, highlighting the importance of tailoring digital health interventions to enhance engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II). Van Blarigan, EL., Dhruva, A., Atreya, CE., et al.[2022]

A 12-week digital health intervention using a Fitbit and daily text messages showed a significant improvement in functional well-being for colorectal cancer survivors, as measured by the FACT-C scale.

While the intervention group experienced a notable increase in their functional well-being, the control group showed no change, suggesting that digital health tools may have a positive impact on quality of life for CRC survivors, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life of colorectal cancer survivors participating in a pilot randomized controlled trial of physical activity trackers and daily text messages. Chan, H., Van Loon, K., Kenfield, SA., 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]

The 'ColorectAlong' smartphone application was developed to aid self-management in colorectal cancer patients, featuring tools for medication, nutrition, pain management, and mental health support.

In a usability study with 17 patients over 2 weeks, the app received a high satisfaction score of 8.03 out of 9, indicating it effectively assists patients in managing their condition and accessing important information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based application for self-management of patients with colorectal cancer: development and usability evaluation. Salmani, H., Nahvijou, A., Sheikhtaheri, A.[2022]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Effects of an interactive coaching intervention on quality of life and psychological factors for colorectal cancer survivors: A single group pre and posttest design. [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

The effectiveness of mHealth for self-management in improving pain, psychological distress, fatigue, and sleep in cancer survivors: a systematic review. [2020]

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

Effect of a technology-supported physical activity intervention on health-related quality of life, sleep, and processes of behavior change in cancer survivors: A randomized controlled trial. [2021]

5. 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]

6. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II). [2022]

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

Quality of life of colorectal cancer survivors participating in a pilot randomized controlled trial of physical activity trackers and daily text messages. [2023]

8. 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]

9. Germany pubmed.ncbi.nlm.nih.gov

Smartphone-based application for self-management of patients with colorectal cancer: development and usability evaluation. [2022]