Young Adult Latino Testicular Cancer Survivors: a Pilot Study of Goal-Focused Emotion Regulation Therapy (GET)

NCT07615998 | Completed DMC

• 1 other identifier: 20205703
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood. Responsive to the need for feasible, effective, and scalable interventions that meet the needs of ethnic minority men, 35 Hispanic/Latino young adults (ages 18-39) with testicular cancer will receive 6 sessions of GET. We will evaluate primary and secondary outcomes at baseline, post-treatment, and 3-month follow-up. In addition, identified biomarkers will be assessed at baseline and post-intervention.

Conditions

Testicular Cancer

Keywords

Testicular Cancer; Young Adult; Depression; Anxiety; Stress

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS)

  The HADS was developed to assess anxiety and depression in medical patients. It purposefully excluded somatic symptoms (e.g., sleep disturbance) to reduce confounding psychological symptoms with disease or treatment. The HADS has become a "benchmark" measure of anxiety and depression among diverse clinical and nonclinical hospital populations, including individuals diagnosed with cancer. The HADS is a 14-item self-administered questionnaire, with 7 items assigned to each the HADS-Anxiety and HADS-Depression subscales. Each item is rated on a 4-point response scale (from 0 to 3). Subscale scores are typically categorized to indicate the level of anxiety or depression experienced where scores of less than 8 are categorized as normal, scores of 8-10 as borderline, and scores of 11-21 as clinical. A number of psychometric studies have established the scale's strengths, including its brevity, reliability, and validity and availability of comparison scores across different populations.

  Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)

Secondary Outcomes (2)

• Cancer Assessment for Young Adults (CAYA-T)

  Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)

• Emotion Regulation Questionnaire (ERQ)

  Baseline (T0), Within 2 weeks of completing last intervention session (T1), Within 2 weeks of 3-months of completing last intervention session (T2)

Other Outcomes (2)

• Salivary Diurnal Cortisol

  Baseline (T0), Within 2 weeks of completing last intervention session (T1)

• Pro-inflammatory Markers (IL-6, IL-1ra, CRP, PD1, TNFaRII, VEGF)

  Baseline (T0), Within 2 weeks of completing last intervention session (T1)

Study Arms (1)

Goal-focused Emotion-regulation Therapy (GET)

EXPERIMENTAL

GET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses. Session topics include a review of cancer-related experiences and influences on goal pursuits, psychoeducation regarding emotions, skills, and values (Session 1), values clarifications and emotional awareness (Session 2), achievability of goals, cognitive skills training (Sessions 3), goal pathway mapping, navigating blocked goals and re-directing energy (Sessions 4), goal motivation and agentic actions, self-care behavior (Session 5), and goal pursuits moving forward (session 6). The first session is 90 minutes and each subsequent session is 60 minutes. Participants are given structured at home exercises via an interactive digital workbook designed to facilitate skill acquisition.

Behavioral: Goal-focused Emotion-regulation Therapy

Interventions

Goal-focused Emotion-regulation Therapy BEHAVIORAL

GET is a 6-session intervention delivered over 8 weeks to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses. Session topics include a review of cancer-related experiences and influences on goal pursuits, psychoeducation regarding emotions, skills, and values (Session 1), values clarifications and emotional awareness (Session 2), achievability of goals, cognitive skills training (Sessions 3), goal pathway mapping, navigating blocked goals and re-directing energy (Sessions 4), goal motivation and agentic actions, self-care behavior (Session 5), and goal pursuits moving forward (session 6). The first session is 90 minutes and each subsequent session is 60 minutes. Participants are given structured at home exercises via an interactive digital workbook designed to facilitate skill acquisition.

Goal-focused Emotion-regulation Therapy (GET)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 39 years at time of consent
• A confirmed diagnosis of testis cancer
• Completion of primary medical treatment for testicular cancer within 4 years at time of consent
• Hispanic/Latino identification (self or cancer registry confirmed)
• A score of \< 1.8 on the goal navigation scale or \< 0.6 on the goal facility scale of the CAYA or \>4 on the Distress Thermometer
• English or Spanish fluency, as per medical record documenting preferred language or in the judgment of the investigator
• Able to perform informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

• Hoyt MA, Campos B, Lechuga JG, Fortier MA, Llave K, Haydon M, Daneshvar M, Nelson CJ, Wu B. Young adult Latino testicular cancer survivors: a pilot study of Goal-focused Emotion regulation Therapy (GET). Support Care Cancer. 2024 Oct 30;32(11):758. doi: 10.1007/s00520-024-08960-y.

  PMID: 39477849 RESULT

MeSH Terms

Conditions

Testicular Neoplasms; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Michael A Hoyt, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: May 29, 2026
• Study Start: August 5, 2020
• Primary Completion: April 4, 2023
• Study Completion: August 14, 2023
• Last Updated: May 29, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)