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Adaptive Symptom Self-Management Immunotherapy Study

RECRUITINGN/ASponsored by University of Arizona
Actively Recruiting
PhaseN/A
SponsorUniversity of Arizona
Started2023-05-08
Est. completion2027-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions6

Breast CancerCancerColon CancerLung CancerRectum CancerSkin Cancer

Locations3 sites

Arizona

2 sites
Valleywise Health Medical Center
Phoenix, Arizona, 85008
Gilbert Ramos480-344-2180gil.ramos@valleywisehealth.org
University of Arizona Cancer Center
Tucson, Arizona, 85724
Molly Hadeed520-626-0583mcbarry@arizona.edu

Michigan

1 site
University of Michigan
Ann Arbor, Michigan, 48109
Samantha Holmes734-998-4425samhol@med.umich.edu

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