RECRUITING

A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors

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

This study is a randomized controlled biobehavioral efficacy trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients. Participants will be randomized to receive six sessions of GET or Individual Supportive Listening (ISL) delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1), twelve weeks after intervention (T2) and 24 weeks after the intervention (T3). Additionally, identified biomarkers will be measured at baseline and at T1, T2, and T3.

Official Title

A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors

Quick Facts

Study Start:2023-11-01
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05836688

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 to 39 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 to 39 years at time of consent
  2. * A confirmed diagnosis of testis cancer (any stage)
  3. * Completion of chemotherapy for testis cancer within 4 years prior to consent
  4. * A score of \>4 on the Distress Thermometer
  5. * English fluency, as per medical record documenting preferred language or in the judgment of the investigator
  6. * Spanish fluency, as per medical record documenting preferred language or in the judgment of the investigator
  7. * Able to perform informed consent
  1. * Lifetime history of psychiatric of cognitive disturbance as per self-report or medical record
  2. * In the judgment of the consenting professional, is unable to provide informed consent and complete study sessions and assessment
  3. * As per self-report, has medical conditions that affect the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; Type I diabetes; acute hepatitis; recent vaccination for viral disease)
  4. * Regular smoker (daily use)

Contacts and Locations

Study Contact

Michael A Hoyt, PhD
CONTACT
949-824-5281
mahoyt@uci.edu

Principal Investigator

Michael A Hoyt, PhD
PRINCIPAL_INVESTIGATOR
University of California, Irvine

Study Locations (Sites)

University of California, Irvine
Irvine, California, 92697-3954
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Michael A Hoyt, PhD, PRINCIPAL_INVESTIGATOR, University of California, Irvine

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 Date2023-11-01
Study Completion Date2028-07

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2028-07

Terms related to this study

Additional Relevant MeSH Terms

  • Testicular Cancer