RecruitingNot ApplicableNCT06338475

A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer


Sponsor

University of California, Irvine

Enrollment

100 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 39 Years

Inclusion Criteria7

  • 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 Criteria3

  • 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)

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Interventions

BEHAVIORALGoal-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.

BEHAVIORALIndividual 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.


Locations(1)

University of California, Irvine

Irvine, California, United States

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NCT06338475


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