This trial studies how well a mobile health decision aid (Cancer/Health Aid to Manage Preferences and Improve Outcomes through Navigation [CHAMPION]) works in improving decision making processes in patients with prostate cancer that has spread extensively to other anatomic sites or is no longer responding to treatment, as well as their decision partners or proxies. CHAMPION may improve decision-making processes or participation preference, enhance patient-doctor communication, and enrich quality of life for patients with prostate cancer and their decision partners or proxies.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03327103.
PRIMARY OBJECTIVES:
I. To test effects of a theory-based mobile health (mHealth) decision aid (DA) (CHAMPION) administered by registered nurse (RN)-community patient navigator (CPN) teams to patients and decision partners/proxies.
SECONDARY OBJECTIVES:
I. To evaluate the community patient navigator (CPN) role in delivery of the mHealth DA (CHAMPION) from the patients’ and decision partners/proxies’ perspective.
II. To obtain preliminary estimates of treatment effects by race to see if the data support a larger effect among African Americans versus others in the primary and secondary aims.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive community patient navigator-administered standard-of-care cancer education material via usual written brochures and pamphlets every 3 months for up to 9 months.
GROUP II: Participants receive enhanced usual care as in Group I. Participants also receive mobile health decision aid at baseline consisting of a group, or series, of short, 30-minute taped lessons to that focuses on understanding quality decision-making. In addition, participants complete a Balance Sheet and Prostate Cancer Symptom Scale (PCSS) questionnaire, receive feedback on the PCSS, and receive guidance about decision-making from a community patient navigator (CPN) every 3 months for up to 9 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorRandy Jones