Web-based CONNECT toolkit to reduce emotional distress and anxiety in rural older cancer survivors
Designing for Sustainability: Co-Designing and Testing the Efficacy of a Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety for Rural Older Cancer Survivors
NA · Northwestern University · NCT07290543
We will test whether CONNECT, a web-based toolkit, can help reduce cancer-related emotional distress and anxiety in rural adults over 65 who have finished cancer treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 578 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07290543 on ClinicalTrials.gov |
What this trial studies
CONNECT is a web-based toolkit designed to address digital literacy and provide individualized resources for managing cancer-related distress and anxiety in rural older survivors. The project begins with a co-design phase using an advisory board of stakeholders to finalize the digital tool. In a randomized trial, rural cancer survivors and their caregivers will be assigned to the CONNECT intervention or a comparison arm and followed with the 23-item Cancer and Treatment Distress Scale (CTXD) as the primary outcome, along with measures of telehealth use, unmet needs, caregiver strain, and healthcare resource utilization. Feasibility and scale-up potential will be examined via qualitative interviews with participants and healthcare stakeholders.
Who should consider this trial
Good fit: Ideal candidates are rural residents aged over 65 who self-report a prior cancer diagnosis, have completed curative-intent treatment, and have access to a smartphone, tablet, or computer.
Not a fit: Patients currently in active cancer treatment, those without internet or device access, non-English speakers, or individuals with severe cognitive impairment are unlikely to benefit from this web-based toolkit.
Why it matters
Potential benefit: If successful, CONNECT could lower distress and anxiety and improve access to mental health resources and telehealth use for rural older cancer survivors.
How similar studies have performed: Some web-based psychosocial interventions have reduced distress in cancer populations, but tailored digital toolkits specifically for rural older survivors are relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AIM 1: Invited by a member of the study team * AIM 1: In the following or related field: * Healthcare professionals (physicians, nurses, pharmacists, etc.) * Patient advocates and representatives * Researchers in healthcare or technology fields * Healthcare administrators and managers * AIM 1: Must be over 18 years old * AIM 1: English-speaking * AIM 1: Willing and able to provide informed consent * AIM 2 (RURAL OLDER CANCER SURVIVORS): A rural resident based on the Health Resources \& Services Administration (HRSA) rural analyzer * AIM 2 (RURAL OLDER CANCER SURVIVORS): Self-report of diagnosis with any cancer * AIM 2 (RURAL OLDER CANCER SURVIVORS): Self-report posttreatment (i.e., completion of curative intent therapy including surgery, chemotherapy, molecularly targeted, and endocrine therapy) * AIM 2 (RURAL OLDER CANCER SURVIVORS): Have access to a computer, a smartphone, or a tablet computer * AIM 2 (RURAL OLDER CANCER SURVIVORS): Aged \> 65 years old * AIM 2 (RURAL OLDER CANCER SURVIVORS): Assessed as having Cancer and Treatment Distress scale (CTXD) scores \> 0.85 at screening * AIM 2 (RURAL OLDER CANCER SURVIVORS): Have a caregiver willing to participate * AIM 2 (RURAL OLDER CANCER SURVIVORS): Non-institutionalized * AIM 2 (RURAL OLDER CANCER SURVIVORS): English proficient * AIM 2 (RURAL OLDER CANCER SURVIVORS): Willing and able to provide informed consent * AIM 2 (CAREGIVER): An identified informal caregiver of an eligible ROCS (caregivers include, but are not limited to, a child, partner, or friend; caregivers can reside in a rural or urban area and may or may not live with the ROCS * AIM 2 (CAREGIVER): Have internet access * AIM 2 (CAREGIVER): ≥ 18 years old * AIM 2 (CAREGIVER): Non-institutionalized * AIM 2 (CAREGIVER): English proficient * AIM 2 (CAREGIVER): Willing and able to provide informed consent * AIM 3 (FINAL WORKSHOP): Includes providers, medical and practice managers, patient care coordinators, and medical health technologists Exclusion Criteria: * AIM 2 (RURAL OLDER CANCER SURVIVORS): Experience a cancer recurrence or a new cancer diagnosis during their participation in the trial because of the body of literature that reports increased distress associated with cancer recurrence * AIM 2 (RURAL OLDER CANCER SURVIVORS AND CAREGIVER): Are inpatients * AIM 2 (RURAL OLDER CANCER SURVIVORS AND CAREGIVER): Cognitive impairment precludes the ability to provide written consent
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Marquita W Lewis, PhD — Northwestern University
- Study coordinator: Study Coordinator
- Email: circle.ruralhealth@northwestern.edu
- Phone: 312-503-1986
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm