Recruiting

CONNECT

Sponsor:

Northwestern University

Code:

NCT07290543

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Educational Intervention

Educational Intervention

Internet-Based Intervention

Interview

Interview

Study Details

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

Study ID

NCT07290543

Start date

Aug 26, 2025

Status verified date

Dec, 2025

Completion date

Aug 26, 2032

Anticipated

Primary completion date

Aug 26, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

578 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (Advisory board)

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

experimental: Arm II (CONNECT platform)

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.

active comparator: Arm III (Educational brochure)

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

Interventions

Educational Intervention

Receive educational materials on distress management and guides to telehealth

Educational Intervention

Receive written educational brochure about distress management

Internet-Based Intervention

Receive access to CONNECT platform

Interview

Complete interview

Interview

Complete small group workshop

Patient Navigation

Receive personalized recommendations for resources

Survey Administration

Ancillary study

Telephone-Based Intervention

Complete calls with research assistant

Text Message-Based Navigation Intervention

Receive text message reminders

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Study Coordinator

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

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Marquita W. Lewis

312-503-1986marquita.lewis-thames@northwestern.edu

Principal Investigator:

Marquita W. Lewis, PhD

More Information

Sponsor

Northwestern University

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2025-12-18.