A Biobehavioral Intervention for Young Men With Testicular Cancer
Status unconfirmed · Phase 2
Conditions studied: Testis Cancer
In brief
This study is a randomized controlled biobehavioral pilot trial designed to investigate the feasibility and preliminary efficacy 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 Therapy (ISP) 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) and twelve weeks after intervention at T2. Additionally, identified biomarkers will be measured at baseline and at T2.
Key facts
- Study ID
- NCT04150848
- Run by
- University of California, Irvine
- People needed
- 100
- Starts
- 2018-11-01
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2020-12-19
Who can join
Age: 18 and older, up to 39. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- between the ages of 18 and 39 years at the time of consent
- confirmed diagnosis of testis cancer (any stage)
- completed chemotherapy for testis cancer within 2 years prior to consent
- fluency in English (per self-report)
- sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale or a score of 4 or greater on the Distress Thermometer (DT)
You may not qualify if…
- lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (per self-report)
- active suicide plan
- disorder that compromises comprehension of assessments or informed consent information
- self-reported medical condition or medication use known to confound measures of systemic inflammation
- daily smoking
Where it is running
- University of California, Irvine — Irvine, California, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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