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Adaptive Symptom Self-Management Immunotherapy Study

Active Not RecruitingNA

Sponsor: University of Arizona

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

Interventions: Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C), Active control comparator

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (3)

Phoenix, Arizona, United States
Tucson, Arizona, United States
Ann Arbor, Michigan, United States