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A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer

NCT06338475 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-25

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Michael A Hoyt, PhD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06338475 on ClinicalTrials.gov