NCT05836688 A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
| NCT ID | NCT05836688 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Irvine |
| Condition | Testicular Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2023-11-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Michael A Hoyt, PhD
PRINCIPAL INVESTIGATOR
University of California, Irvine
Frequently Asked Questions
Who can join the NCT05836688 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 39 Years, studying Testicular Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05836688 currently recruiting?
Yes, NCT05836688 is actively recruiting participants. Contact the research team at mahoyt@uci.edu for enrollment information.
Where is the NCT05836688 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT05836688 clinical trial?
NCT05836688 is sponsored by University of California, Irvine. The principal investigator is Michael A Hoyt, PhD at University of California, Irvine. The trial plans to enroll 250 participants.
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