Adaptive Symptom Self-Management Immunotherapy Study

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer, Colon Cancer, Lung Cancer, Skin Cancer, Rectum Cancer

In brief

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.

Key facts

Study ID

NCT05715255

Run by

University of Arizona

People needed

400

Starts

2023-05-08

Expected to finish

2027-04-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Currently receiving regular behavioral counseling

Where it is running

• Valleywise Health Medical Center — Phoenix, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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