Recruiting

Biobehavioral Intervention

Sponsor:

UCLA

Code:

NCT05836688

Conditions

Testicular Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Goal-Focused Emotion-Regulation Therapy (GET)

Individual Supportive Listening

Study Details

Brief 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.

Conditions

Testicular Cancer

Study ID

NCT05836688

Start date

Nov 1, 2023

Status verified date

Apr, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 to 39 years at time of consent
  • A confirmed diagnosis of testis cancer (any stage)
  • Completion of chemotherapy for testis cancer within 4 years prior to consent
  • A score of >4 on the Distress Thermometer
  • English fluency, as per medical record documenting preferred language or in the judgment of the investigator
  • Spanish fluency, as per medical record documenting preferred language or in the judgment of the investigator
  • Able to perform informed consent

Exclusion Criteria:

  • Lifetime history of psychiatric of cognitive disturbance as per self-report or medical record
  • In the judgment of the consenting professional, is unable to provide informed consent and complete study sessions and assessment
  • 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)
  • Regular smoker (daily use)

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Goal-Focused Emotion-Regulation Therapy (GET)

A novel behavioral intervention to enhance self-regulation through improved goal navigation skills, improved sense of purpose, and better ability to regulate emotional responses in young adults with testicular cancer.

active comparator: Individual Supportive Listening

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.

Interventions

Goal-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.

Individual 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.

Primary outcome measure

  • Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks) ]
  • Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein [CRP], sTNFαRII) [ Time Frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks) ]
  • Change in Salivary Diurnal Cortisol Slope and Daily Output [ Time Frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks) ]

Central Contacts and Locations

Central contacts

Michael A Hoyt, PhD

949-824-5281mahoyt@uci.edu

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92697-3954

Contacts

Michael A Hoyt, PhD

949-824-5281mahoyt@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

May 1, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2025-05-01.