A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 39
Healthy Volunteers: f
View:

• 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

• English fluency, as per medical record documenting preferred language or in the judgment of the investigator

• Spanish fluency, as per medical record documenting preferred language or in the judgment of the investigator

• Able to perform informed consent

Locations
United States
California
University of California, Irvine
RECRUITING
Irvine
Contact Information
Primary
Michael A Hoyt, PhD
mahoyt@uci.edu
949-824-5281
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2028-07
Participants
Target number of participants: 250
Treatments
Experimental: Goal-Focused Emotion-Regulation Therapy (GET)
A novel behavioral intervention to enhance self-regulation through improved goal navigation skills, improved sense of purpose, and better ability to regulate emotional responses in young adults with testicular cancer.
Active_comparator: Individual Supportive Listening
Supportive therapy will be non-directive and will primarily reinforce a patient's ability to manage stressors through attentively listening and encouraging expression of thoughts and feelings, assisting the individual to gain a greater understanding of their situation and alternatives, and helping to buttress the individual's self-esteem and resilience.
Related Therapeutic Areas
Sponsors
Collaborators: Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI)
Leads: University of California, Irvine

This content was sourced from clinicaltrials.gov