RECRUITING

Adaptive Symptom Self-Management Immunotherapy Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-08
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05715255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older
  2. * Within 12 weeks after starting ICI treatment for cancer
  3. * Cognitively oriented to person, place and time (determined by recruiter)
  4. * Able to speak and understand English or Spanish
  5. * Access to a telephone
  6. * 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
  1. * Currently receiving regular behavioral counseling

Contacts and Locations

Study Contact

Molly Hadeed
CONTACT
520-626-0583
mcbarry@arizona.edu

Principal Investigator

Terry Badger, PhD
PRINCIPAL_INVESTIGATOR
University of Arizona

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Arizona

  • Terry Badger, PhD, PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-08
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2023-05-08
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • Cancer
  • Cancer Survivors
  • Immunotherapy
  • Immune Checkpoint Inhibitors
  • Symptom Management
  • Psychosocial Oncology
  • Telephone Intervention

Additional Relevant MeSH Terms

  • Breast Cancer
  • Colon Cancer
  • Lung Cancer
  • Skin Cancer
  • Rectum Cancer