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

NCT07290543 | Recruiting DMC

• 5 other identifiers: NU 24CC20NCI-2024-09384STU00222660P30CA060553R01NR021666
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year

Secondary Outcomes (5)

• 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

• Cancer Survivors' Unmet Needs (validated 35-item scale)

  Up to 12 months

• Caregiver Strain Index (validated 13-item scale)

  Up to 12 months

Study Arms (3)

Arm I (Advisory board)

EXPERIMENTAL

Advisory board members complete small group workshops, interviews and surveys on study.

Other: Interview; Other: Survey Administration

Arm II (CONNECT platform)

EXPERIMENTAL

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.

Other: Educational Intervention; Other: Internet-Based Intervention; Other: Interview; Behavioral: Patient Navigation; Other: Survey Administration; Behavioral: Telephone-Based Intervention; Other: Text Message-Based Navigation Intervention

Arm III (Educational brochure)

ACTIVE COMPARATOR

Patients are mailed an educational brochure about distress management on study.

Other: Educational Intervention; Other: Interview; Other: Survey Administration

Interventions

Educational Intervention OTHER

Receive educational materials on distress management and guides to telehealth

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm II (CONNECT platform)

Internet-Based Intervention OTHER

Receive access to CONNECT platform

Arm II (CONNECT platform)

Interview OTHER

Complete interview

Arm I (Advisory board); Arm II (CONNECT platform); Arm III (Educational brochure)

Patient Navigation BEHAVIORAL

Receive personalized recommendations for resources

Also known as: Patient Navigator Program

Arm II (CONNECT platform)

Survey Administration OTHER

Ancillary study

Arm I (Advisory board); Arm II (CONNECT platform); Arm III (Educational brochure)

Telephone-Based Intervention BEHAVIORAL

Complete calls with research assistant

Arm II (CONNECT platform)

Text Message-Based Navigation Intervention OTHER

Receive text message reminders

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

Arm II (CONNECT platform)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods; Interviews as Topic; Patient Navigation

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Marquita W Lewis, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

312-503-1986; circle.ruralhealth@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study staff abstracting the data will be blinded to the participant's condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 18, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): August 26, 2031
• Study Completion (Estimated): August 26, 2032
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)