Status:
RECRUITING
Comprehensive Outcomes for After Cancer Health
Lead Sponsor:
Pack Health
Collaborating Sponsors:
Daiichi Sankyo
GlaxoSmithKline
Conditions:
Ovarian Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Background: There are an estimated 16.9 million cancer survivors in the United States, accounting for approximately 5% of the entire US population, and this number is anticipated to increase by 31% ov...
Eligibility Criteria
Inclusion
- Have primary diagnosis of cancer;
- Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer
- For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up with or without maintenance therapy
- For individuals with metastatic cancer, individuals may be included provided they completed primary therapy for a de novo diagnosis of metastatic disease within the last year, are within one year of completion of initial therapy for their primary cancer diagnosis for which disease progression has occurred, or who are within one year of receiving treatment for metastatic disease (including individuals currently receiving treatment).
- 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. a smart phone or tablet) that would allow engagement in digital health coaching for the collection of PROs and wearable data.
Exclusion
- Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program or complete study assessments;
- Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)
- Have a life expectancy of \<6 months, and/or
- Are on active treatment for relapsed disease. a. Individuals with disease progression or relapse which occurs following their consent to participate will be given the option to continue on study if they wish to do so. Data from individuals experiencing disease progression or relapse will be grouped for sub-analysis to explore if and how relapse impacts study outcomes.
- Healthy Volunteers must:
- Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older.
- Must reside in the same dwelling as the patient participant
- Can read and consent to participate in the trial;
- Can read and speak English;
- Can complete study follow-up at pre-specified intervals;
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT05349227
Start Date
June 23 2022
End Date
May 1 2027
Last Update
December 11 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Florida
Gainesville, Florida, United States, 32610
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68106
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065