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
Summary
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.
Detailed description
PRIMARY OBJECTIVES: I. Co-design Objective (Aim 1): Finalize the CONNECT digital tool design through qualitative co-design evaluations with stakeholders to prepare the intervention for efficacy testing. II. Efficacy Objective (Aim 2): Evaluate the efficacy of the CONNECT digital tool in reducing cancer-related distress among rural cancer survivors and caregivers, as measured by the validated 23-item Cancer and Treatment Distress Scale (CTXD), in a randomized controlled trial. III. Implementation Objective (Aim 3): Assess the feasibility and potential for scale-up of the CONNECT intervention in rural communities and healthcare settings through qualitative interviews. SECONDARY OBJECTIVES: I. Assess self-reported healthcare resource utilization over the 12-month study period. (Aim 2, Efficacy Testing) II. Assess self-reported shared device use for accessing health-related information and services. (Aim 2, Efficacy Testing) III. Assess self-reported telehealth utilization, including portal use, completed visits, and visit modality. (Aim 2, Efficacy Testing) IV. Evaluate cancer survivors' unmet needs using a validated 35-item unmet needs survey. (Aim 2, Efficacy Testing) V. Evaluate caregiver strain using the validated 13-item 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: Co-design / Advisory Board Arm (Non-randomized) Advisory board members participate in qualitative co-design activities to refine the CONNECT digital tool prior to efficacy testing. Activities include small-group workshops, interviews, field-testing, and surveys focused on usability, content relevance, and acceptability of the platform. ARM II: Intervention (CONNECT) Arm: Participants receive access to the CONNECT digital platform, which includes educational materials on cancer-related distress management, guidance on telehealth use, and personalized recommendations for supportive resources. They complete a guided onboarding tutorial with a Study Team Member, receive up to four structured review sessions (20 minutes each) by phone or video, and get automated text message reminders every two weeks for four months to encourage engagement. Control Arm: Participants receive usual care plus a mailed educational brochure about managing cancer-related distress. They do not receive access to the CONNECT platform or coaching sessions. ARM III: Patients are mailed an educational brochure about distress management on study. AIM 3: Scale-up / Implementation Assessment A subsample of participants from Arms II and III will participate in exit interviews to assess potential implementation outcomes, sustainability, and barriers/facilitators for scaling CONNECT in rural communities and healthcare settings.
Arms & interventions
- OtherEducational Intervention
Receive educational materials on distress management and guides to telehealth
- OtherEducational Intervention
Receive written educational brochure about distress management
- OtherInternet-Based Intervention
Receive access to CONNECT platform
- OtherInterview
Complete interview
- OtherInterview
Complete small group workshop
- BehavioralPatient Navigation
Receive personalized recommendations for resources
- OtherSurvey Administration
Ancillary study
- BehavioralTelephone-Based Intervention
Complete calls with research assistant
- OtherText Message-Based Navigation Intervention
Receive text message reminders
Outcome measures
Primary
Cancer Related Distress (validated 23-item scale)
Cancer-related distress will be measured using the Cancer and Treatment Distress Scale (23 items; item scores 0-3; higher scores indicate greater distress). The CTXD assesses distress over the past week and includes six subscales: (1) uncertainty, (2) family strain, (3) health burden, (4) finances, (5) identity/appearance, and (6) medical demands. The primary outcome is the mean cumulative score across all items and subscales. A mean score above 0.85 indicates elevated distress in long-term survivors. The CTXD has demonstrated high validity and reliability across time, from pre-treatment to 18 years post-treatment, with Cronbach's alphas ranging from 0.77 to 0.90. The subscales align with the psychosocial domain identified in the NCCN Guidelines for Distress Management.
Time frame: Up to 1 year
Secondary
Self-reported Healthcare Resource Usage
Time frame: Up to 12 months
Self-reported Shared Device Use
Time frame: Up to 12 months
Telehealth Utilization (self-reported use of portal, completed visits, and visit modality)
Time frame: Up to 12 months
Cancer Survivors' Unmet Needs (validated 35-item scale)
Time frame: Up to 12 months
Caregiver Strain Index (validated 13-item scale)
Time frame: Up to 12 months
Eligibility criteria
Study locations (1)
Northwestern University
Chicago, Illinois, 60611