Actively Recruiting
A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
Led by University of California, Irvine · Updated on 2025-05-01
250
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
M
Memorial Sloan Kettering Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 39 years at time of consent
- Confirmed diagnosis of testis cancer at any stage
- Completed chemotherapy for testis cancer within 4 years prior to consent
- Score greater than 4 on the Distress Thermometer
- Fluent in English or Spanish as documented or judged by the investigator
- Able to provide informed consent
You will not qualify if you...
- Lifetime history of psychiatric or cognitive disturbance by self-report or medical record
- Unable to provide informed consent or complete study sessions and assessments as judged by staff
- Medical conditions affecting the immune system that could affect immune evaluation (e.g., autoimmune disorder, inflammatory disease, uncontrolled thyroid disease, active infection, recent heart attack or stroke, Type I diabetes, acute hepatitis, recent viral vaccination)
- Regular daily smoker
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, Irvine
Irvine, California, United States, 92697-3954
Actively Recruiting
Research Team
M
Michael A Hoyt, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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