Recruiting

Biobehavioral Intervention

Sponsor:

UCLA

Code:

NCT06338475

Conditions

Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Goal-Focused Emotion-Regulation Therapy (GET)

Individual Supportive Listening (ISL)

Study Details

Brief summary:

Building upon the results of a single-arm trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), this trial is a randomized-controlled biobehavioral pilot trial of GET versus a time-and attention matched control (Instrumental Supportive Listening; ISL) in Latino/Hispanic young adult survivors of adolescent and young adult (AYA) cancer (age 15-39 years at diagnosis). Outcomes include improved distress symptoms, emotion regulation, goal navigation skills, and changes in stress-sensitive biomarkers.

Participants will be randomized to receive six sessions of GET or ISL delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary and secondary psychological outcomes prior to (T0), immediately after (T1), and twelve weeks after intervention (T2). Additionally, identified biomarkers will be measured at baseline and at T1, and T2.

Conditions

Cancer

Study ID

NCT06338475

Start date

Jun 1, 2024

Status verified date

Mar, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 to 39 years at time of consent
  • Male gender; self-identified
  • A confirmed diagnosis of cancer (any stage)
  • Diagnosed with cancer between the ages of 15 and 39
  • Hispanic/Latino identification
  • A score ≤ 1.8 on the Goal Navigation Scale or ≥ 4 on the Distress Thermometer
  • English or Spanish fluency

Exclusion Criteria:

  • lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (self-report)
  • compromised cognitive capacity
  • self-reported medical condition or medication use known to confound measures of systemic inflammation (e.g., autoimmune disorder, active infection)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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 (ISL)

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.

Interventions

Goal-Focused Emotion-Regulation Therapy (GET)

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 (ISL)

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.

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) ]
  • Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFαRII) [ Time Frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks) ]
  • Change in Salivary Diurnal Cortisol Daily Output [ Time Frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks) ]

Central Contacts and Locations

Central contacts

Michael A Hoyt, PhD

949-824-5281mahoyt@uci.edu

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92617

Contacts

Michael Hoyt, PhD

(949) 824-5281mahoyt@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Mar 25, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2025-03-25.