Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
MALE
ID05836688

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

N/A

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

Researchers are evaluating a new behavioral intervention called Goal-focused Emotion-Regulation Therapy (GET) aimed at reducing distress, improving emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult men diagnosed with testicular cancer. This randomized controlled trial compares GET to Individual Supportive Listening (ISL) to understand their effects on psychological and biological outcomes. The study focuses on young adults aged 18 to 39 who have completed chemotherapy and experience distress related to their cancer. Participants will be randomly assigned to receive either six sessions of GET or ISL over eight weeks. GET helps patients identify meaningful personal goals, refine them, and develop strategies to overcome obstacles while improving emotional regulation and sense of purpose. ISL provides supportive, non-directive therapy focused on listening and encouraging expression of thoughts and feelings. Both interventions are delivered individually via an interactive video platform to improve access. During the study, participants will complete assessments at baseline, immediately after treatment, and at three- and six-month follow-ups. These include questionnaires measuring depression, anxiety, emotion regulation, goal navigation, career confusion, and spiritual well-being. Researchers will also collect biological samples to measure stress hormones and inflammatory markers. The study aims to evaluate the feasibility, acceptability, and effects of these interventions on psychological distress and biological stress indicators in young adult testicular cancer survivors.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 39Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 39 years at time of consent
  • Confirmed diagnosis of testicular cancer at any stage
  • Completion of chemotherapy for testicular 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 investigator
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Lifetime history of psychiatric or cognitive disturbance
  • Unable to provide informed consent or complete study sessions and assessments
  • Medical conditions affecting the immune system that may confound 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)
  • Daily smoker

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Approximately 8 weeks

Participants receive either the Goal-Focused Emotion-Regulation Therapy (GET) or Individual Supportive Listening (ISL) over 6 sessions to help manage distress and improve emotional regulation after testicular cancer treatment.

6 sessions delivered via an interactive video platform

Follow-up

Duration - Up to 6 months post-intervention

Participants are monitored to assess the lasting effects of the intervention on psychological distress, biobehavioral indicators, and goal navigation.

2 follow-up assessments at 3 months and 6 months post-intervention

Trial Site Locations

Total: 1 location

1

University of California, Irvine

Irvine, California, United States, 92697-3954

Actively Recruiting

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Research Team

M

Michael A Hoyt, PhD

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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Published Research Related To This Trial

Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol.

Michael A Hoyt, Ashley Wei-Ting Wang, Sean J Ryan...

https://pubmed.ncbi.nlm.nih.gov/32290859

Goal-focused Emotion-Regulation Therapy for young adult survivors of testicular cancer: Feasibility of a behavioral intervention.

Michael A Hoyt, Christian J Nelson

https://pubmed.ncbi.nlm.nih.gov/32913918

A Randomized Controlled Trial of Goal-Focused Emotion-Regulation Therapy for Young Adult Survivors of Testicular Cancer: Effects on Salivary and Inflammatory Stress Markers.

Michael A Hoyt, Ashley W Wang, Elizabeth C Breen...

https://pubmed.ncbi.nlm.nih.gov/34514890