NCT04150848

A Biobehavioral Intervention for Young Men With Testicular Cancer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Male
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Testis Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Goal-Focused Emotion Regulation Therapy (GET)	Six sessions delivered individually over 8 weeks
BEHAVIORAL	Individual Supportive Psychotherapy (ISP)	Six sessions delivered individually over 8 weeks

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2019-11-05
• Last updated: 2020-12-19

Locations

2 sites across 1 country: United States