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New program aims to ease mental and physical side effects of immunotherapy

NCT ID NCT05715255

Symptom relief Sponsor: University of Arizona Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tests a personalized self-management program to help cancer survivors on immune checkpoint inhibitors better handle side effects and reduce anxiety or depression. About 400 adults with breast, colon, lung, skin, or rectal cancer who recently started immunotherapy will take part. Participants will report symptoms weekly and receive guidance to manage them, with the goal of improving quality of life and reducing treatment disruptions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm colon carcinoma colonic neoplasm lung cancer lung neoplasm neoplasm rectal cancer rectal neoplasm skin cancer skin neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Colon cancer Lung cancer Rectum cancer Skin cancer

Contacts and locations

Locations

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Valleywise Health Medical Center

    Phoenix, Arizona, 85008, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.