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.
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).
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.
Crossover
Digital Health Coaching Program
BehavioralCoaching consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.
Fitbit
DeviceDevice: Fitbit A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.
Acceptability of coaching intervention
A 3-item questionnaire evaluating the following: 1) The digital health coaching program is easy to participate in; 2) the digital health coaching program is useful to me; 3) the digital health coaching program is relevant to my survivorship experience. Responses will be provided on a 10-point Likert scale ranging from 1 (Not at all) to 10 (Very Much).
Feasibility of coaching intervention
A retention rate greater than or equal to 70%. Retention is defined as individuals who agree to participate in the digital health coaching program completing the 6-months of engagement post-enrollment.
Change in Self-Efficacy for Managing Chronic Disease
A 6-item instrument measures how confident an individual is in engaging in certain health management activities. Responses are provided on a 10-point scale ranging from 1(not at all confident) to 10 (totally confident). A mean score is calculated for the instrument with a higher score indicating higher self-efficacy.
Change in the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Physical Function 10a
A 12-item instrument assessing respondents' abilities to perform physical tasks and activities of daily living. Items are scored on 5-point Likert scales, with higher scores indicating higher physical functioning.
Change in Quality of Life as measured by The Functional Assessment of Cancer Therapy - General v4 (FACT-G)
A 27-item instrument using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much) to measure QoL across four dimensions: physical, social/family, emotional and functional. The FACT-G, validated for use with individuals with diverse cancer types, in addition to condition specific items as available by tumor type.
Change in Anxiety as measured by the PROMIS Anxiety Short Form 8a
An 8-item instrument measuring indicators of anxiety with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater anxiety.
Change in Depression as measured by the PROMIS Depression Short Form 8a
An 8-item instrument measuring indicators of depression with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater depression.
Dietary Intake as measured by the Diet History Questionnaire (DHQ) III
An electronic food diary assessment capturing dietary intake over the last 24 hours. The number of items
Change in medication adherence for individuals taking maintenance therapies
A three-item instrument used to measure medication adherence, asking about difficulty taking medications on time, average days per week with one dose missed, and the last time a dose was missed. Responses are on differing scales, with higher values meaning better adherence.
Physical Activity
Step count will be collected via Fitbits provided to study participants
Physical Activity
Minutes of physical activity will be collected via Fitbits provided to study participants
Click on the lead sponsor to view all of their trials.
Pack Health
Lead sponsor
Daiichi Sankyo
Collaborator
GlaxoSmithKline
Collaborator
University of Nebraska
Collaborator
Ohio State University Comprehensive Cancer Center
Collaborator
The University of Texas Health Science Center, Houston
Collaborator
M.D. Anderson Cancer Center
Collaborator
University of Florida
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
Dana-Farber Cancer Institute
Collaborator
Gilead Sciences
Collaborator
National Institute of Nursing Research (NINR)
Collaborator
