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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Valleywise Health Medical Center
RECRUITING
Phoenix
University of Arizona Cancer Center
RECRUITING
Tucson
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Molly Hadeed
mcbarry@arizona.edu
520-626-0583
Time Frame
Start Date: 2023-05-08
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 400
Treatments
Experimental: Adaptive Intervention
The adaptive intervention sequence is assumed to affect psychological distress (depression and anxiety) severity of other symptoms and irAEs, as tested in Aim 1. Both the Automated Telephone Symptom Management (ATSM) system and the Telephone Interpersonal Counseling (TIP-C) interventions help participants to identify and understand troublesome symptoms, with suggestions to effectively self-manage these symptoms. The proposed interventions are expected to alleviate burdensome symptoms through several key mediating variables, as tested in Aim 2.
Active_comparator: Active Control
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. An active control comparator was purposively selected to enable a more rigorous testing of intervention effectiveness in Aims 1 and 2. Also, the study team will be better able to address the question about which channel of communication (automated versus survivor initiated) results in better outcomes.
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: University of Arizona

This content was sourced from clinicaltrials.gov