Digital Health Coaching for Cancer Survivorship

(COACH Trial)

Recruiting at6 trial locations

Overseen by Kathrin Milbury, MA,PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Pack Health

Disqualifiers: Cognitive impairment, Neurologic, Musculoskeletal, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.

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 seems likely that you can continue your medications, especially if they are part of your ongoing cancer treatment.

What data supports the effectiveness of the Digital Health Coaching Program treatment for cancer survivors?

Research shows that digital health interventions, including mobile health (mHealth) programs with activity trackers and coaching, can improve physical activity and diet among cancer survivors. Many participants reported satisfaction with these interventions, and some studies found significant improvements in behavior and quality of life. ^{1 2 3 4 5}

Is digital health coaching safe for cancer survivors?

The research does not specifically mention any safety concerns related to digital health coaching for cancer survivors, suggesting it is generally considered safe for use in humans. ^{5 6 7 8 9}

How is the Digital Health Coaching Program different from other treatments for cancer survivorship?

The Digital Health Coaching Program is unique because it uses mobile health technology to provide personalized coaching for cancer survivors, helping them manage their health and lifestyle from home. Unlike traditional treatments that focus solely on medical interventions, this program emphasizes improving lifestyle behaviors such as diet and physical activity, and offers ongoing support to enhance adherence and motivation. ^{1 6 7 10 11}

Research Team

Alexi A. Wright

Principal Investigator

Dana-Farber Cancer Institute

Kathrin Milbury, MA,PHD

Principal Investigator

The University of Texas MD Anderson Cancer Center

Marilyn Hammer, PhD

Principal Investigator

Dana-Farber Cancer Institute

Elizabeth Arthur, PhD

Principal Investigator

Ohio State University

Jessica L. Krok-Schoen, PhD

Principal Investigator

Ohio State University

Robin Lally, PhD

Principal Investigator

The University of Nebraska

Kristen Fessele, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Rachael Schmidt, DNP

Principal Investigator

Nebraska Medicine

Debra E Lyon, PhD

Principal Investigator

University of Florida College of Nursing

Anneliese Gonzalez, MD

Principal Investigator

UTHealth Houston McGovern Medical School

Eligibility Criteria

This trial is for cancer survivors who've finished their primary therapy within the last year. Participants must be adults (18+), able to read and speak English, consent to join, follow the study schedule, use a smartphone or tablet, and wear a Fitbit. Excluded are those with cognitive impairments, less than 6 months life expectancy, conditions limiting physical activity, or active treatment for relapsed disease.

Inclusion Criteria

I finished my main cancer treatment less than a year ago and am now in follow-up or maintenance.

I have a smartphone or tablet for digital health coaching.

Can read and consent to participate in the trial;

Exclusion Criteria

Your doctor believes you may not live longer than 6 months.

I am currently receiving treatment for my cancer that has come back.

I am able to understand and interact with a digital health program.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Health Coaching (Intervention Group)

Participants receive a 6-month digital health coaching program with weekly person-to-person calls and digital nudges.

6 months

Weekly virtual interactions

Monitoring (Control Group)

Participants are monitored via patient-reported outcomes, clinical data, and wearable data collection for 6 months.

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including microbiome and PRO data collection.

6 months

Data collection at months 3, 6, 9, and 12

Treatment Details

Interventions

• Digital Health Coaching Program (Behavioral Intervention)
• Fitbit (Device)

Trial Overview The study tests a digital health coaching program alongside Fitbit monitoring in cancer survivors post-treatment. It's set up so half of the participants start with coaching right away and then switch to just monitoring after 6 months; the other half do it in reverse order. They'll also give fecal samples to check gut health changes.

Participant Groups

Group I: Wait List Control Group Experimental Treatment 2 Interventions

In addition to standard of care services, individuals in the wait list control will be monitored via the collection of PRO, clinical, and wearable data for the first 6 months, along with fecal microbiome collection at study enrollment baseline (study enrollment) and month 6. At month 6 these individuals will be enrolled into the 6-month digital health coaching program, during which clinical, PRO and wearable data will continue to be collected. At the completion of the 6-month coaching these individuals will come off study and will not receive additional follow-up.

Group II: Intervention Group Experimental Treatment 2 Interventions

In addition to standard of care services at the participant's respective health system, and study specific collection of clinical, PRO, and wearable data, as well as microbiome specimens, individuals randomized to the intervention group will receive immediate enrollment to a 6-month digital health coaching program followed by 6 months monitoring via PRO, wearable, and clinical data collection. They will collect fecal microbiome samples at baseline (study enrollment) and month 6 following enrollment.

Group III: Household Healthy Participants Active Control 1 Intervention

A cohort of consisting of adults without a cancer diagnosis residing in the same residence as participants, will be consented to collect fecal microbiome specimens to serve as a control for potential regional variation in microbiome dysbiosis. Up to 25 healthy controls will be enrolled per 100 participants at each study site. At sites enrolling fewer than 100 participants, an n up to 25% of the total patient enrollment sample will be approached for enrollment.

Who Is Running the Clinical Trial?

Pack Health

Lead Sponsor

Trials

6

Recruited

1,100+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Dr. LaTanya Love

The University of Texas Health Science Center, Houston

Interim President

MD from UT Medical Branch in Galveston

Dr. Jagat Narula

The University of Texas Health Science Center, Houston

Chief Academic Officer since 2023

MD, PhD

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

Daiichi Sankyo, Inc.

Industry Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

Findings from Research

Digital health interventions (DI) show promise in helping cancer patients and survivors manage their disease and treatment side effects, with a high level of patient engagement reported across 24 studies.

Despite the potential benefits of DI on psychosocial factors like self-efficacy and quality of life, the results were inconsistent, highlighting the need for standardized methods in future research to better understand their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health interventions to help living with cancer: A systematic review of participants' engagement and psychosocial effects. Escriva Boulley, G., Leroy, T., Bernetière, C., et al.[2022]

A systematic review of 23 randomized controlled trials involving cancer survivors showed that mobile health (mHealth) interventions significantly improved physical activity and dietary habits, with 11 out of 18 studies reporting notable behavioral changes.

Participants expressed high satisfaction with the mHealth interventions, with a median satisfaction rate of 87%, indicating that these technology-based approaches are well-received and feasible for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Interventions to Promote a Healthy Diet and Physical Activity among Cancer Survivors: A Systematic Review of Randomized Controlled Trials. Wang, L., Langlais, CS., Kenfield, SA., et al.[2022]

A systematic review of eight studies on digital self-management interventions for childhood cancer survivors found that these interventions did not significantly improve health-related quality of life or moderate-to-vigorous physical activity, indicating limited effectiveness.

While the interventions showed a trend towards increasing physical activity over time, the results were not statistically significant, highlighting the need for better-designed studies to assess their true impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of digital self-management interventions on health outcomes among childhood cancer survivors: A systematic review and meta-analysis. Hong, HC., Min, A., Kim, YM.[2021]

Digital health innovations, especially through internet and smartphone applications, are proving effective in managing symptoms and supporting cancer survivors and their caregivers, with evidence of improved clinical outcomes and patient-centered care.

Despite the potential benefits, challenges such as lack of engagement from patients and professionals, feelings of depersonalization, and the burden of technology need to be addressed to enhance the implementation of these digital health solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging role of digital health in monitoring and supporting people living with cancer and the consequences of its treatments. Harris, J., Cheevers, K., Armes, J.[2019]

A pilot trial successfully enrolled 74 breast cancer survivors in a digital health intervention aimed at improving nutrition and physical activity, demonstrating feasibility despite challenges posed by the COVID-19 pandemic.

The intervention included varying doses of support (1 vs. 12 sessions) and provided participants with tools like a Fitbit and weekly motivational texts, indicating a comprehensive approach to promoting healthier lifestyles among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital health intervention to improve nutrition and physical activity in breast cancer survivors: Rationale and design of the Cook and Move for Your Life pilot and feasibility randomized controlled trial. Ueland, K., Sanchez, SC., Rillamas-Sun, E., et al.[2023]

A pilot study involving 88 men with prostate cancer demonstrated that a 12-week digital health coaching program was feasible, with 71.6% of participants completing the program, exceeding the feasibility threshold of 60%.

The coaching program covered various topics relevant to prostate cancer management, indicating that digital health coaching could be a valuable tool for improving patient engagement and self-management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Feasibility Study of Digital Health Coaching for Men With Prostate Cancer. Handley, NR., Wen, KY., Gomaa, S., et al.[2022]

Breast cancer survivors using a health and wellness coaching app showed significant weight loss and a greater reduction in body mass index compared to those using a self-guided toolkit, indicating the app's effectiveness in promoting healthier lifestyles.

The app users also reported improvements in physical activity and dietary patterns, suggesting that access to live coaching can enhance adherence to wellness plans, although long-term app usage declined after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Mobile Health Intervention to Improve Wellness Outcomes for Breast Cancer Survivors. Cairo, J., Williams, L., Bray, L., et al.[2022]

A study involving 87 breast and colorectal cancer survivors showed that using a Fitbit and receiving health coaching significantly increased their moderate-to-vigorous physical activity (MVPA) by nearly 50 minutes per week compared to those who only received printed materials.

This research is the first to demonstrate that combining wearable technology with remote health coaching can effectively enhance physical activity levels in cancer survivors living in remote areas, suggesting a promising approach for improving health outcomes in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS). Hardcastle, SJ., Maxwell-Smith, C., Cavalheri, V., et al.[2023]

A review of 13 studies on health coaching combined with telehealth for older adults showed that 10 of these studies reported effective outcomes, such as reduced hospital admissions and improved quality of life.

While telehealth health coaching is a promising method for managing chronic conditions in older adults, most interventions still rely on human coaches, indicating a potential for further development of automated coaching technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Telehealth Technology to Support Health Coaching for Older Adults: Literature Review. Markert, C., Sasangohar, F., Mortazavi, BJ., et al.[2021]

Cancer survivors showed improved motivation and adherence to an 8-week online health behavior change program, particularly when supported by family and healthcare providers, highlighting the importance of social relations in eHealth interventions.

Participants, averaging 62 years old, were familiar with digital tools, suggesting that a supportive digital environment and tailored design features can enhance the effectiveness of online health coaching for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of motivation and adherence to a web application for health behaviour change: A qualitative study with cancer survivors. Delestre, F., Debailly, R., Galiby, LA., et al.[2023]

This study will compare the effectiveness of a mobile health application combined with face-to-face rehabilitation versus the app alone in improving the Quality of Life for breast cancer survivors, involving women aged 25 to 75 with specific health criteria.

The primary outcome will be assessed after 8 weeks, focusing on Quality of Life, while secondary outcomes will include body composition, functionality, cognitive function, and mental health, highlighting the importance of both technology and professional support in cancer rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. Lozano-Lozano, M., Martín-Martín, L., Galiano-Castillo, N., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Digital health interventions to help living with cancer: A systematic review of participants' engagement and psychosocial effects. [2022]

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

mHealth Interventions to Promote a Healthy Diet and Physical Activity among Cancer Survivors: A Systematic Review of Randomized Controlled Trials. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effectiveness of digital self-management interventions on health outcomes among childhood cancer survivors: A systematic review and meta-analysis. [2021]

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

The emerging role of digital health in monitoring and supporting people living with cancer and the consequences of its treatments. [2019]

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

A digital health intervention to improve nutrition and physical activity in breast cancer survivors: Rationale and design of the Cook and Move for Your Life pilot and feasibility randomized controlled trial. [2023]

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

A Pilot Feasibility Study of Digital Health Coaching for Men With Prostate Cancer. [2022]

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

Evaluation of a Mobile Health Intervention to Improve Wellness Outcomes for Breast Cancer Survivors. [2022]

8. China pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS). [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

The Use of Telehealth Technology to Support Health Coaching for Older Adults: Literature Review. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Determinants of motivation and adherence to a web application for health behaviour change: A qualitative study with cancer survivors. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. [2022]