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

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT05836688
Status
Recruiting
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Conditions

  • Testicular Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Goal-Focused Emotion-Regulation Therapy (GET) — BEHAVIORAL
    Patients will be asked to identify value-derived goals (i.e., goals for the most important domains of one's life) and ones sufficiently important to sustain movement toward them in the short-term future. Patients will discuss their goal possibilities, providing a forum to ensure that goals are manageable and consistent with identified values. Patients will learn strategies to refine their goals (e.g., approaching goals rather than avoiding obstacles, defining markers of progress), generate pathways to goals, and address potential obstacles and blockages. The overall goal is to enhance self-regulation through improved goal navigation skills, improved sense of meaning and purpose, and better ability to regulate specific emotional responses.
  • Individual Supportive Listening — BEHAVIORAL
    ISL sessions will be matched in terms of time and attention. 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. This will be delivered in the same manner as GET (individually) and is a common, non-directive control method in intervention research.

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Apr 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92697-3954
Michael A Hoyt, PhD
[email protected]
949-824-5281

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By research site
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