Actively Recruiting
Comprehensive Outcomes for After Cancer Health
Led by Pack Health ยท Updated on 2024-12-11
625
Participants Needed
7
Research Sites
253 weeks
Total Duration
On this page
Sponsors
P
Pack Health
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comprehensive Outcomes for After Cancer Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a primary diagnosis of cancer
- Within 1 year of completion of primary therapy or have a diagnosis of metastatic cancer
- Are aged 18 years and 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 (e.g. smartphone or tablet) for digital health coaching and data collection
You will not qualify if you...
- Have cognitive impairment preventing engagement with coaching or assessments
- Have neurologic, musculoskeletal, or other conditions limiting physical activity
- Have a life expectancy of less than 6 months
- Are on active treatment for relapsed disease (though may continue if relapse occurs after consent)
AI-Screening
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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
Research Team
K
Kelly J Brassil, PhD
CONTACT
J
Jennifer Loftis, DNP
CONTACT
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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