Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
MALE
ID06338475

A Biobehavioral Intervention for Latino/Hispanic Young Adult Males with Cancer involving Goal-Focused Emotion-Regulation Therapy versus Supportive Listening

Led by University of California, Irvine · Updated on 2025-03-25

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new biobehavioral intervention called Goal-focused Emotion-Regulation Therapy (GET) for Latino/Hispanic young adult males who survived cancer diagnosed between ages 15 and 39. This study compares GET to an active control called Individual Supportive Listening (ISL). The goal is to improve distress symptoms, emotional regulation, goal navigation skills, and reduce stress-related biological markers. The trial builds on earlier research showing a high risk of distress and adverse outcomes in young Hispanic/Latino cancer survivors, aiming to address psychological and biobehavioral challenges during young adulthood. Participants will be randomly assigned to receive six sessions of GET or ISL over eight weeks. GET focuses on helping individuals set and pursue meaningful goals, regulate emotions related to cancer, and improve self-regulation skills. ISL provides supportive therapy through attentive listening and encouragement without directive advice. Both interventions are delivered individually via an interactive video platform to improve access. The study also explores how cultural factors like Familism and Acculturative Stress may influence outcomes. During the study, participants will complete assessments at baseline, immediately after the intervention, and three months later. Researchers will measure psychological outcomes such as anxiety, depression, spiritual well-being, career thoughts, and emotional coping, along with stress-sensitive biomarkers including inflammatory cytokines and salivary cortisol patterns. The study includes monitoring intervention feasibility and cultural influences. Participation will last about 20 weeks from baseline through follow-up.

CONDITIONS

Brief Title

A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer

Who Can Participate

Age: 18Years - 39Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 39 years at time of consent
  • Male gender; self-identified
  • Confirmed diagnosis of cancer at any stage
  • Diagnosed with cancer between ages 15 and 39
  • Self-identify as Hispanic or Latino
  • Score of 1.8 or less on the Goal Navigation Scale or 4 or higher on the Distress Thermometer
  • Fluency in English or Spanish
Not Eligible

You will not qualify if you...

  • Lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder (self-reported)
  • Compromised cognitive capacity
  • Medical condition or medication use known to affect systemic inflammation (e.g., autoimmune disorder, active infection) (self-reported)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Outpatient Treatment

Duration - Approximately 8 weeks

Participants receive 6 sessions of a behavioral intervention (either Goal-Focused Emotion-Regulation Therapy or Individual Supportive Listening) delivered via an interactive video platform to help manage cancer-related distress and improve emotional regulation and goal navigation skills.

6 sessions conducted individually via video platform

Follow-up

Duration - Approximately 12 weeks after treatment completion

Participants are assessed to evaluate the lasting effects of the intervention on distress, biobehavioral indicators, and emotional well-being.

1 follow-up visit (remote or in-person)

Trial Site Locations

Total: 1 location

1

University of California, Irvine

Irvine, California, United States, 92617

Actively Recruiting

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Research Team

M

Michael A Hoyt, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol.

Michael A Hoyt, Ashley Wei-Ting Wang, Sean J Ryan...

https://pubmed.ncbi.nlm.nih.gov/32290859

Goal-focused Emotion-Regulation Therapy for young adult survivors of testicular cancer: Feasibility of a behavioral intervention.

Michael A Hoyt, Christian J Nelson

https://pubmed.ncbi.nlm.nih.gov/32913918

A Randomized Controlled Trial of Goal-Focused Emotion-Regulation Therapy for Young Adult Survivors of Testicular Cancer: Effects on Salivary and Inflammatory Stress Markers.

Michael A Hoyt, Ashley W Wang, Elizabeth C Breen...

https://pubmed.ncbi.nlm.nih.gov/34514890