NCT05715255Active, not recruiting
Adaptive Symptom Self-Management Immunotherapy Study
Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers (HCPs) may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 27 Jan 2023
- Start date
- 8 May 2023
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- University of Arizona
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT05715255
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 8 May 2023 to the primary completion date, 30 Apr 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving regular behavioral counseling
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Valleywise Health Medical Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| University of Arizona Cancer Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.