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A Biobehavioral Intervention (GET) for the Reduction of Adverse Outcomes in Young Adult Testicular Cancer Survivors
Trial Status: active
This clinical trial compares the impact of Goal-focused Emotion-Regulation Therapy (GET) to individual supportive psychotherapy (ISP) on navigating life goals and managing emotions in young adult testicular cancer survivors. Testicular cancer diagnosis and treatment, especially given the impact on sexuality and reproductive health, can be distressing in young adults. Studies have shown that depressive symptoms are higher in testicular cancer patients, however, there are few effective interventions to assist young survivors in re-negotiating life goals and regulating cancer-related emotions. Behavioral interventions, such as GET counseling, use techniques including identifying value-derived goals and discussing strategies to refine and attain goals to enhance self-regulation. ISP, uses non-directive supportive listening and encouraging expression of thoughts and feelings to reinforce management of stressors. Participating in GET sessions compared to ISP sessions may increase coping skills and improve quality of life in young adult testicular cancer survivors.
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 2 years prior to consent
A score of < 1.8 on the goal navigation scale or < 0.6 on the goal facility scale of the Cancer Assessment for Young Adults (CAYA) or > 4 on the distress thermometer
English 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)
Additional locations may be listed on ClinicalTrials.gov for NCT05836688.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
I. Determine the efficacy of GET as compared to ISP in improving depressive symptoms (primary outcomes) as well as emotion regulation, goal attainment skills, and career confusion (secondary outcomes) in young adult testicular cancer patients.
II. Examine the relative change in salivary markers of distress-relevant biomarkers (i.e., diurnal cortisol parameters) and inflammation (i.e., soluble tumor necrosis factor-alpha receptor II, Interleukin 6) in young adult testicular cancer patients receiving GET versus ISP.
III. Evaluate adaptive emotion regulation and goal attainment skills as a self-regulation mechanism of GET to reduce depressive symptoms.
EXPLORATORY OBJECTIVE:
I. Evaluate the relative ability of GET to alter epigenetic vulnerability (deoxyribonucleic acid [DNA] methylation) with a focus on NR3C1 (glucocorticoid receptor gene) and SLC6A4 (serotonin transporter gene).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in GET sessions over 1-1.5 hours for 6 sessions in 8-14 weeks. Patients also undergo saliva and oral swab collection throughout study.
ARM II: Patients participate in ISP sessions over 1-1.5 hours for 6 sessions in 8-14 weeks. Patients also undergo saliva and oral swab collection throughout study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
