Self-management support for cancer patients using automated phone calls
Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors
This study is testing if automated phone calls can help cancer survivors manage their symptoms better during treatment and improve their communication with doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Trial ID | NCT05715255 on ClinicalTrials.gov |
What this trial studies
This study aims to improve symptom management for cancer survivors undergoing immune checkpoint inhibitor treatment by utilizing an Automated Telephone Symptom Management (ATSM) system. Participants will be randomized to receive either ATSM, which includes weekly symptom monitoring and reporting, or an active control group that only receives symptom monitoring. The study will also explore the addition of Telephone Interpersonal Counseling (TIP-C) for those who continue to experience psychological distress. The goal is to enhance self-efficacy in managing symptoms and improve communication with healthcare providers, ultimately reducing adverse events and healthcare utilization.
Who should consider this trial
Good fit: Ideal candidates are cancer survivors aged 18 or older who are within 12 weeks of starting immune checkpoint inhibitor treatment and experiencing elevated psychological distress.
Not a fit: Patients currently receiving regular behavioral counseling may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of immune-related adverse events in cancer patients, improving their overall treatment experience.
How similar studies have performed: Other studies have shown promise in using automated symptom management approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Within 12 weeks after starting ICI treatment for cancer * Cognitively oriented to person, place and time (determined by recruiter) * Able to speak and understand English or Spanish * Access to a telephone * Severity score of 1 (mild) or higher on at least 1 of the 3 indicators of psychological distress from the PRO-CTCAE (i.e., the three items of anxious, discouraged, sad) library Exclusion Criteria: * Currently receiving regular behavioral counseling
Where this trial is running
Phoenix, Arizona and 2 other locations
- Valleywise Health Medical Center — Phoenix, Arizona, United States (Recruiting)
- University of Arizona Cancer Center — Tucson, Arizona, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Terry Badger, PhD — University of Arizona
- Study coordinator: Molly Hadeed
- Email: mcbarry@arizona.edu
- Phone: 520-626-0583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.