Effect of a self-management program on patients with chronic disease.
K R Lorig, D S Sobel, P L Ritter...
https://pubmed.ncbi.nlm.nih.gov/11769298Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05349227
Comprehensive Outcomes for After Cancer Health (COACH): Feasibility and Impact of a Digital Health Coaching Program for Cancer Survivors
Led by Pack Health · Updated on 2024-12-11
625
Participants Needed
7
Research Sites
21 weeks
Total Duration
On this page
Sponsors
P
Pack Health
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a digital health coaching program designed to support individuals who have completed primary cancer therapy. This study focuses on cancer survivors within one year of finishing their treatment or those with metastatic cancer. The goal is to explore how digital coaching might improve health self-efficacy, physical and psychosocial well-being, and the restoration of gut microbiome health after cancer therapy. Participants will be randomly assigned to either receive six months of digital health coaching followed by six months of monitoring, or six months of monitoring followed by six months of coaching. The coaching includes weekly personal calls and up to four digital messages per week covering topics such as symptom management, diet, exercise, fatigue, financial concerns, medication adherence, and mental health. All participants will wear Fitbit devices to track physical activity and provide fecal microbiome samples at the start and after six months. Over 12 months, participants will complete patient-reported outcomes at multiple time points to assess quality of life, symptom burden, mental health, cognitive function, sleep, sexual health, and financial toxicity. Clinical data, wearable activity data, and microbiome analysis will be collected to examine associations between health behaviors, symptoms, and gut flora. This comprehensive approach aims to better understand the needs of cancer survivors beyond clinical care and how digital coaching might support their ongoing health management.
CONDITIONS
Brief Title
Comprehensive Outcomes for After Cancer Health
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Have a primary diagnosis of cancer
- Are within 1 year of completing primary therapy or have metastatic cancer
- Are 18 years of age or older
- Can read and consent to participate in the trial
- Can read and speak English
- Can complete study follow-up at pre-specified intervals
- Have access to mobile technology such as a smartphone or tablet for digital coaching
You will not qualify if you...
- Have cognitive impairments that prevent engagement with coaching or study assessments
- Have neurologic, musculoskeletal, or other conditions limiting physical activity
- Have a life expectancy less than 6 months
- Are on active treatment for relapsed disease (except those who choose to continue after progression)
- Healthy volunteers must be adults 18 years or older, live in the same household as a patient participant, and meet language and follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) for enrollment and baseline assessments
Digital Health Coaching Program
Duration - 6 months
Participants receive weekly coaching calls and up to 4 digital messages per week focused on managing symptoms, wellness, and adherence to care to improve quality of life and health outcomes.
Weekly coaching calls and ongoing digital content delivery
Monitoring
Duration - 6 months
Participants are monitored through clinical data collection, patient-reported outcomes (PROs), wearable device tracking, and microbiome sample collection to assess health and wellness after coaching.
PROs collected at months 3, 6, 9, and 12; microbiome samples collected at baseline and month 6; daily wearable device tracking
Trial Site Locations
Total: 7 locations
1
The University of Florida
Gainesville, Florida, United States, 32610
Active, Not Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68106
Active, Not Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
5
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Active, Not Recruiting
6
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
7
UT Health Houston
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
K
Kelly J Brassil, PhD
J
Jennifer Loftis, DNP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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Self-management: Enabling and empowering patients living with cancer as a chronic illness.
Ruth McCorkle, Elizabeth Ercolano, Mark Lazenby...
https://pubmed.ncbi.nlm.nih.gov/21205833The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies.
Philip L Ritter, Kate Lorig
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S B Yellen, D F Cella, K Webster...
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M J Brady, D F Cella, F Mo...
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https://pubmed.ncbi.nlm.nih.gov/20960518PROMIS depression measures perform similarly to legacy measures relative to a structured diagnostic interview for depression in cancer patients.
Kerrie Clover, Sylvie D Lambert, Christopher Oldmeadow...
https://pubmed.ncbi.nlm.nih.gov/29423755Responsiveness of 8 Patient-Reported Outcomes Measurement Information System (PROMIS) measures in a large, community-based cancer study cohort.
Roxanne E Jensen, Carol M Moinpour, Arnold L Potosky...
https://pubmed.ncbi.nlm.nih.gov/27696377