RecruitingNot ApplicableNCT05836688

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


Sponsor

University of California, Irvine

Enrollment

250 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a biobehavioral intervention — a program combining psychological support, behavioral strategies, and biological monitoring — to reduce emotional distress and adverse health outcomes in young adult men (ages 18–39) who have completed chemotherapy for testicular cancer. Testicular cancer survivors often experience ongoing anxiety, depression, and immune changes even after successful treatment. **You may be eligible if...** - You are a man between 18 and 39 years old - You have been diagnosed with testicular cancer (any stage) - You finished chemotherapy within the past 4 years - You are experiencing moderate-to-significant emotional distress (score above 4 on the Distress Thermometer) - You are fluent in English or Spanish **You may NOT be eligible if...** - You have a history of psychiatric or cognitive disorders - You have medical conditions affecting the immune system (autoimmune disease, recent infection, recent heart attack or stroke, etc.) - You are a regular daily smoker 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALGoal-Focused Emotion-Regulation Therapy (GET)

Patients will be asked to identify value-derived goals (i.e., goals for the most important domains of one's life) and ones sufficiently important to sustain movement toward them in the short-term future. Patients will discuss their goal possibilities, providing a forum to ensure that goals are manageable and consistent with identified values. Patients will learn strategies to refine their goals (e.g., approaching goals rather than avoiding obstacles, defining markers of progress), generate pathways to goals, and address potential obstacles and blockages. The overall goal is to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses.

BEHAVIORALIndividual Supportive Listening

ISL sessions will be matched in terms of time and attention. Supportive therapy will be non-directive and will primarily reinforce a patient's ability to manage stressors through attentively listening and encouraging expression of thoughts and feelings, assisting the individual to gain a greater understanding of their situation and alternatives, and helping to buttress the individual's self-esteem and resilience. This will be delivered in the same manner as GET (individually) and is a common, non-directive control method in intervention research.


Locations(1)

University of California, Irvine

Irvine, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05836688


Related Trials