NCT07290543 · Northwestern University
Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety in Rural Older Cancer Survivors
What this study is about
This clinical trial tests how well a web based toolkit works to improve cancer related emotional distress and anxiety in rural older cancer survivors.
View original scientific description
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Collaborators
National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 18, 2025 · Source of record for eligibility and locations