RECRUITING

A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer

Quick Facts

Study Start:2024-06-01
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06338475

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 39 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 to 39 years at time of consent
  2. * Male gender; self-identified
  3. * A confirmed diagnosis of cancer (any stage)
  4. * Diagnosed with cancer between the ages of 15 and 39
  5. * Hispanic/Latino identification
  6. * A score ≤ 1.8 on the Goal Navigation Scale or ≥ 4 on the Distress Thermometer
  7. * English or Spanish fluency
  1. * lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (self-report)
  2. * compromised cognitive capacity
  3. * self-reported medical condition or medication use known to confound measures of systemic inflammation (e.g., autoimmune disorder, active infection)

Contacts and Locations

Study Contact

Michael A Hoyt, PhD
CONTACT
949-824-5281
mahoyt@uci.edu

Principal Investigator

Michael A Hoyt, PhD
PRINCIPAL_INVESTIGATOR
University of California, Irvine

Study Locations (Sites)

University of California, Irvine
Irvine, California, 92617
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-06-01
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer