A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer

NCT06338475 | Recruiting

• 1 other identifier: 5510
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in Hospital Anxiety and Depression Scale (HADS)

  The HADS was developed to assess anxiety and depression in medical patients. It purposefully excluded somatic symptoms (e.g., sleep disturbance) to reduce confounding psychological symptoms with disease or treatment. The HADS has become a "benchmark" measure of anxiety and depression among diverse clinical and nonclinical hospital populations, including individuals diagnosed with cancer. The HADS is a 14-item self-administered questionnaire, with 7 items assigned to each the HADS-Anxiety and HADS-Depression subscales. Each item is rated on a 4-point response scale (from 0 to 3). Subscale scores are typically categorized to indicate the level of anxiety or depression experienced where scores of less than 8 are categorized as normal, scores of 8-10 as borderline, and scores of 11-21 as clinical. A number of psychometric studies have established the scale's strengths, including its brevity, reliability, and validity and availability of comparison scores across different populations.

  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)

  The investigators will focus on four biomarkers, IL-6, IL-1ra, CRP, sTNFαRII, that indicate systemic inflammation and are associated with distress symptoms and emotion regulation. Levels will be assessed from plasma. Cytokine levels will be determined by immunosorbent assay (ELISA) according to assay manufacturer's protocols. All samples will be run in duplicate, and assays will be repeated on two separate days; intra-assay and interassay mean levels will be used in all analyses.

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)

• Change in Salivary Diurnal Cortisol Daily Output

  Diurnal rhythm in salivary cortisol will be measured over three days at each assessment. Participants will collect saliva samples in their natural environment upon awakening, 30 minutes later, 8 hours later, and at bedtime. Participants will complete a diary to assess relevant health behaviors (e.g., caffeine, tobacco, alcohol consumption; physical activity, sleep) as well as daily stress. They will be instructed to avoid brushing their teeth, eating, or drinking within 20 minutes before sampling. Participants will keep samples refrigerated prior to returning them to the research laboratory and returned salivettes will be stored in a -20-degree Celsius freezer until analyzed. Salivary cortisol will be analyzed with a time-resolved fluorescence immunoassay. Cortisol output will be measured by area under the daily curve and total daily cortisol output.

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)

Secondary Outcomes (7)

• Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) Subscale Score

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)

• Change in Career Thoughts Inventory (CTI) Global Score

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)

• Change in Emotion Regulation Questionnaire (ERQ) Scale Scores

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)

• Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)

• Change in Emotional Approach Coping Questionnaire (EAC) Scale Scores

  Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)

Study Arms (2)

Goal-Focused Emotion-Regulation Therapy (GET)

EXPERIMENTAL

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.

Behavioral: Goal-Focused Emotion-Regulation Therapy (GET)

Individual Supportive Listening (ISL)

ACTIVE COMPARATOR

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.

Behavioral: Individual Supportive Listening (ISL)

Interventions

Goal-Focused Emotion-Regulation Therapy (GET) BEHAVIORAL

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.

Goal-Focused Emotion-Regulation Therapy (GET)

Individual Supportive Listening (ISL) BEHAVIORAL

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.

Individual Supportive Listening (ISL)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: This study tests an intervention developed specifically for male young adult cancer survivors.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92617, United States

RECRUITING

Related Publications (3)

• Hoyt MA, Wang AW, Ryan SJ, Breen EC, Cheavens JS, Nelson CJ. Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol. Trials. 2020 Apr 14;21(1):325. doi: 10.1186/s13063-020-04242-0.

  PMID: 32290859 BACKGROUND

• Hoyt MA, Nelson CJ. Goal-focused Emotion-Regulation Therapy for young adult survivors of testicular cancer: Feasibility of a behavioral intervention. Contemp Clin Trials Commun. 2020 Aug 21;19:100648. doi: 10.1016/j.conctc.2020.100648. eCollection 2020 Sep.

  PMID: 32913918 BACKGROUND

• Hoyt MA, Wang AW, Breen EC, Nelson CJ. A Randomized Controlled Trial of Goal-Focused Emotion-Regulation Therapy for Young Adult Survivors of Testicular Cancer: Effects on Salivary and Inflammatory Stress Markers. Am J Mens Health. 2021 Sep-Oct;15(5):15579883211044557. doi: 10.1177/15579883211044557.

  PMID: 34514890 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Michael A Hoyt, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Hoyt, PhD

CONTACT

949-824-5281; mahoyt@uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: March 29, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

US (1)