This trial studies the effect of an eHealth coaching program (PACK Health) on patient reported outcomes of men with prostate cancer. An electronic health support program may affect prostate cancer patients' reported side effects and outcomes of care.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04106245.
PRIMARY OBJECTIVES:
I. To model the trajectory of patient reported outcomes (PROs), as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale (version [v]1.2), among men with non-metastatic prostate cancer who are engaged in either active surveillance or first definitive active surgical or radiation treatment, while enrolled in an e-health coaching program.
Ia. To compare the trajectories of (PROs) between men who are engaged in either active surveillance or first definitive surgical or radiation active treatment, while enrolled in an e-health coaching program.
SECONDARY OBJECTIVES:
I. To evaluate the effect of digital health coaching program on:
Ia. Physical and mental health of men with non-metastatic prostate cancer as measured by the subscales of the PROMIS Global Health Scale (v 1.2).
Ib. The global health outcomes of men with non-metastatic prostate cancer who are in active treatment by active treatment type (i.e. surgery, radiation, or radiation plus hormonal therapy).
Ic. The symptom experience of men with non-metastatic prostate cancer as measured by the MD Anderson Symptom Inventory (MDASI).
Id. The frequency of emergency room visits and hospital admissions for patients receiving treatment in the ambulatory setting.
II. To evaluate the relationship between financial toxicity, as measured by the Consumer Score for Financial Toxicity (COST), and quality of life, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP).
III. To determine changes in diet, as measured by the Mediterranean Diet Adherence Screener (MEDAS) and physical activity, as measured by the International Physical Activity Questionnaire (IPAQ), of men with non-metastatic prostate cancer before and after an eHealth coaching program.
IV. To evaluate difference in physical and mental health, symptom burden, and quality of life between men who complete at least half of an eHealth coaching program and men who abandon an eHealth coaching program.
OUTLINE:
Patients are contacted once weekly by a health coach by text message, phone call, email, or a mobile application, for 3 months. The total time interacting with the health coach is about 3.5-4.5 hours across the study. Patients also complete surveys over 30 minutes each time at baseline and every 30 days for 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorEileen D. Hacker