Summary

Eligibility
for males ages 18-39 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Biobehavioral Intervention for Young Men With Testicular Cancer: A Pilot Study

Keywords

Testis Cancer Testicular Neoplasms Goal-Focused Emotion Regulation Therapy (GET) Individual Supportive Psychotherapy (ISP)

Eligibility

You can join if…

Open to males ages 18-39

  • 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 CAN'T join 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

Locations

  • University of California, Irvine accepting new patients
    Irvine California 92697-3957 United States
  • Memorial Sloan Kettering Cancer Center accepting new patients
    New York New York 10017 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT04150848
Phase
Phase 2
Study Type
Interventional
Last Updated