This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors. By improving access to survivorship resources, health literacy, self-management skills, and support, an interactive survivorship program may help to improve adherence to adolescent and young adult healthcare guidelines and reduce cancer-related distress.
Additional locations may be listed on ClinicalTrials.gov for NCT04593277.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Among adolescent and young adult (AYA) survivors with elevated cancer-related distress, determine the efficacy of a self-management program, Interactive Survivorship Program to Improve Healthcare Resources (INSPIRE), delivered by interactive digital cross-device options (mobile app/web) and social media, with stepped care telehealth coaching, compared to an active control arm in which survivors receive access to a website with annotated survivor resource links and delayed access to the INSPIRE program.
II. Among AYA survivors with inadequate adherence to healthcare guidelines, determine the efficacy of the INSPIRE digital and telehealth self-management program compared to active controls.
SECONDARY OBJECTIVES:
I. Examine mechanisms associated with intervention efficacy including engagement with the online program, use of telehealth contacts, and improved health self-efficacy, health literacy, AYA-specific impact of cancer, and barriers to healthcare.
II. Examine moderators of intervention engagement or response including cancer clinical factors, health status, personal factors, and sociodemographic and environmental factors.
III. Define costs of maintaining and delivering components of the INSPIRE program if delivered in a scaled-up model of care, including the health informatics system, the mobile app, website, social media and telehealth.
EXPLORATORY OBJECTIVES:
I. Examine reach, feasibility/acceptability and engagement in INSPIRE to assess dissemination potential.
II. Using baseline data, determine risk models for poorer health status, healthcare non-adherence, and distress based on clinical, sociodemographic, socioeconomic, psychosocial, functional, and access factors.
OUTLINE: Patients who have one or more elevated distress or low cardiometabolic or cancer health care adherence are randomized to Arm I or II.
ARM I (INTERVENTION): Patients receive a personalized survivorship care plan (SCP) and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.
ARM II (CONTROL): Patients receive access to a study-specific control website that has annotated links to existing resources for AYA survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorK. Scott Baker
