A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
Recruiting now · Not applicable
Conditions studied: Testicular Cancer
In brief
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.
Key facts
- Study ID
- NCT05836688
- Run by
- University of California, Irvine
- People needed
- 250
- Starts
- 2023-11-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2025-05-01
Who can join
Age: 18 and older, up to 39. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
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)
Where it is running
- University of California, Irvine — Irvine, California, United States (enrolling)
Full record on ClinicalTrials.gov
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