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Active Not RecruitingNot applicableNCT05715255
Official study title

Adaptive Symptom Self-Management Immunotherapy Study

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedAutomated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C) and Active control comparator

The study team can explain what participation involves.

Who it may be forBreast Cancer · Colon Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 31, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?University of Arizona

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
University of Arizona
Interventions being studied
Behavioral: Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C); Behavioral: Active control comparator
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Immunotherapy→Supportive or behavioral care→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion criteria

Currently receiving regular behavioral counseling

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Valleywise Health Medical CenterPhoenix, Arizona
  • University of Arizona Cancer CenterTucson, Arizona
  • University of MichiganAnn Arbor, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 31, 2026. Always confirm current availability with the study team.

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