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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Northwestern University
- Enrollment
- 578
- Locations
- 1
- Primary Endpoint
- Cancer Related Distress (validated 23-item scale)
Study Overview
Brief 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Study staff abstracting the data will be blinded to the participant's condition.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Cancer Related Distress (validated 23-item scale)
Time Frame: Up to 1 year
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.
Secondary Outcomes
- Self-reported Healthcare Resource Usage(Up to 12 months)
- Self-reported Shared Device Use(Up to 12 months)
- Telehealth Utilization (self-reported use of portal, completed visits, and visit modality)(Up to 12 months)
- Caregiver Strain Index (validated 13-item scale)(Up to 12 months)
- Cancer Survivors' Unmet Needs (validated 35-item scale)(Up to 12 months)