Biobehavioral intervention for young adult testicular cancer survivors
A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
This study is testing a new therapy to help young adult testicular cancer survivors manage their emotions and stress better, comparing it to regular supportive listening over eight weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Male |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT05836688 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and acceptability of a novel intervention called Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms and emotional regulation in young adult testicular cancer survivors. Participants will be randomly assigned to receive either GET or Individual Supportive Listening over six sessions within eight weeks. The study will measure psychological outcomes such as depressive and anxiety symptoms, emotion regulation, and goal navigation skills at multiple time points. Additionally, biomarkers related to stress will be assessed to evaluate the intervention's impact on physical health.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18 to 39 who have completed chemotherapy for testicular cancer within the last four years and are experiencing distress.
Not a fit: Patients with a lifetime history of psychiatric or cognitive disturbances may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the emotional and psychological well-being of young adult testicular cancer survivors.
How similar studies have performed: Other studies have shown success with similar biobehavioral interventions in cancer survivorship, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Irvine, California
- University of California, Irvine — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: Michael A Hoyt, PhD — University of California, Irvine
- Study coordinator: Michael A Hoyt, PhD
- Email: mahoyt@uci.edu
- Phone: 949-824-5281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.