RecruitingNot ApplicableNCT05715255

Adaptive Symptom Self-Management Immunotherapy Study

Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors


Sponsor

University of Arizona

Enrollment

400 participants

Start Date

May 8, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital tool designed to help cancer patients manage emotional side effects — like anxiety, sadness, and discouragement — that can occur while receiving immunotherapy. Participants use a phone or app-based program to track and address their mental health symptoms alongside treatment. **You may be eligible if...** - You are 18 or older - You started immunotherapy (immune checkpoint inhibitor) for cancer within the last 12 weeks - You are experiencing at least mild anxiety, sadness, or discouragement based on a short questionnaire - You can speak and understand English or Spanish - You have access to a telephone **You may NOT be eligible if...** - You are already receiving regular behavioral or mental health counseling Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAutomated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)

Participants randomized to the adaptive intervention are telephoned weekly and asked to enter by pin-pad or voice the severity of the PRO-CTCAE items on a 0-4 scale, with 0 being none and 4 being very severe. Participants are mailed the Symptom Management and Survivorship Handbook in their preferred language (English or Spanish). Survivors who rated any item at moderate or higher (2-4) will be referred by the ATSM to read the corresponding chapters in the Handbook and given a call back in 24 hours to inquire about the severity of the reported symptom, whether it has improved or worsened, and whether the participant reported it to their HCP, or the HCP has contacted the survivor. Participants that report elevated symptoms for two consecutive weeks are rerandomized to continue the ATSM alone or continue the ATSM with TIP-C added for 8 weeks. TIP-C is delivered by a masters prepared counselor with cancer expertise via weekly 30-minute phone calls using interpersonal techniques.

BEHAVIORALActive control comparator

Survivors in the active control will receive weekly AVR assessments of PROCTCAE symptoms, and summary of these assessments will be sent securely to HCPs. Survivors will not receive the Handbook and will not be prompted by the AVR to contact HCPs unless the symptoms are severe.


Locations(3)

Valleywise Health Medical Center

Phoenix, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

University of Michigan

Ann Arbor, Michigan, United States

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NCT05715255


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