This clinical trial tests how well a web based toolkit works to improve cancer related emotional distress and anxiety in rural older cancer survivors. Rural older adults with cancer-related distress are particularly vulnerable to poorer mental health and cancer-related outcomes including increased difficulties identifying symptoms of anxiety, a reduced likelihood of knowing when to access mental health services, and a higher likelihood of having poorly managed CRD, even after receiving a psychosocial referral. The web based tool kit called CONNECT addresses digital literacy and supports for cancer-related distress management through interactive activities for setting up telehealth visits, accessing educational materials about cancer-related distress, and providing individualized mental health resource recommendations. Using CONNECT may improve cancer related emotional distress and anxiety in rural older cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07290543.
Locations matching your search criteria
United States
Illinois
Chicago
Northwestern UniversityStatus: Active
Contact: Marquita W. Lewis-Thames
Phone: 312-503-1986
PRIMARY OBJECTIVES:
I. Finalize the CONNECT digital tool design for efficacy testing through qualitative co-design evaluations. (Aim 1, Co-design)
II. Assess the efficacy of the CONNECT digital tool in reducing cancer-related distress in an RCT. (Aim 2, RCT)
III. Assess potential scale-up implementation of CONNECT in rural communities and healthcare settings. (Aim 3, Scale-up Interviews)
SECONDARY OBJECTIVES:
I. Self-reported telehealth utilization. (Aim 2, Efficacy Testing)
II. Self-reported shared device use. (Aim 2, Efficacy Testing)
III. Self-reported healthcare resources usage. (Aim 2, Efficacy Testing)
IV. 35-item validated cancer survivors’ unmet needs survey. (Aim 2, Efficacy Testing)
V. 13-item validated caregiver strain index. (Aim 2, Efficacy Testing)
OUTLINE: Advisory board members are assigned to arm I, patients and their caregivers are randomized to arm II or III.
ARM I: Advisory board members complete small group workshops, interviews and surveys on study.
ARM II: Patients and their caregivers receive access to the CONNECT platform, which includes educational materials on distress management, guides to telehealth and personalized recommendations for resources. Patients and their caregivers complete a guided tutorial of the platform with a research assistant at the start of the intervention period, receive biweekly phone calls with the research assistant, for 20 minutes starting on 14 days to 2 months to review the four cancer-related management functions and receive a text message reminders to encourage use, every 2 weeks for 4 months.
ARM III: Patients are mailed an educational brochure about distress management on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNorthwestern University
Principal InvestigatorMarquita W. Lewis-Thames
