Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety in Rural Older Cancer Survivors

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07290543
Status
Recruiting
Apply to this trial

Conditions

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Educational Intervention — OTHER
    Receive educational materials on distress management and guides to telehealth
  • Educational Intervention — OTHER
    Receive written educational brochure about distress management
  • Internet-Based Intervention — OTHER
    Receive access to CONNECT platform
  • Interview — OTHER
    Complete interview
  • Interview — OTHER
    Complete small group workshop
  • Patient Navigation — BEHAVIORAL
    Receive personalized recommendations for resources
  • Survey Administration — OTHER
    Ancillary study
  • Telephone-Based Intervention — BEHAVIORAL
    Complete calls with research assistant
  • Text Message-Based Navigation Intervention — OTHER
    Receive text message reminders

Study Details

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.

Key Dates

Start date
Aug 26, 2025
Status verified
Dec 2025
Primary completion
Aug 26, 2031
Completion
Aug 26, 2032

Study Design

Enrollment
578 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (Advisory board)
    Advisory board members complete small group workshops, interviews and surveys on study.
  • Experimental: Arm II (CONNECT platform)
    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.
  • Active Comparator: Arm III (Educational brochure)
    Patients are mailed an educational brochure about distress management on study.

Primary Outcome Measure

Cancer Related Distress (validated 23-item scale) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Marquita W. Lewis
[email protected]
312-503-1986
Marquita W. Lewis, PhD (PRINCIPAL_INVESTIGATOR)

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