Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05715255

Adaptive Symptom Self-Management Immunotherapy Study

Led by University of Arizona · Updated on 2026-05-14

400

Participants Needed

3

Research Sites

207 weeks

Total Duration

On this page

Sponsors

U

University of Arizona

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Adaptive Symptom Self-Management Immunotherapy Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Currently receiving regular behavioral counseling

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Valleywise Health Medical Center

Phoenix, Arizona, United States, 85008

Active, Not Recruiting

2

University of Arizona Cancer Center

Tucson, Arizona, United States, 85724

Actively Recruiting

3

University of Michigan

Ann Arbor, Michigan, United States, 48109

Active, Not Recruiting

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Research Team

M

Molly Hadeed

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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