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Not Yet Recruiting
NCT05715255
Adaptive Symptom Self-Management Immunotherapy Study
Conditions: Breast Cancer, Colon Cancer, Lung Cancer, Skin Cancer, Rectum Cancer
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 400
Sponsor: University of Arizona
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age 18 or olderWithin 12 weeks after starting ICI treatment for cancerCognitively oriented to person, place and time (determined by recruiter)Able to speak and understand English or SpanishAccess to a telephoneSeverity 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) libraryExclusion Criteria:Currently receiving regular behavioral counseling
Source: ClinicalTrials.gov (NCT05715255). StuddyBuddy aggregates publicly available trial information.