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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (5)

• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Northwestern University — Chicago

Identifiers

NCT: NCT07290543 · NU 24CC20 · NCI-2024-09384 · STU00222660 · NU 24CC20 · P30CA060553 · R01NR021666

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗