About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Goal-Focused Emotion-Regulation Therapy (GET)
- Individual Supportive Listening
Treatment groups
Sponsors and collaborators
University of California, Irvine
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborator
National Cancer Institute (NCI)
Collaborator