Clinical trial NCT06338475: A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer
Official title: A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Cancer diagnosis and treatment can be distressing in the formative period of young adulthood. Cohort studies reveal the prevalence of depressive symptoms in young cancer survivors exceeds the general population, and young Hispanic/Latino men are at particular risk for adverse outcomes after treatment. In fact, the majority of young adult cancer survivors will experience impairing, distressing, and modifiable physical, behavioral, and psychosocial adverse outcomes that persist long after the completion of primary medical treatment. These include psychological distress, impairment in the navigation and pursuit of life goals, persistent side effects, elevated risk of secondary malignancies and chronic illness, and biobehavioral burden (e.g., enhanced inflammation, dysregulated stress hormones) which influence morbidity and disease-related vulnerabilities. However, few targeted, tailored, culturally-relevant interventions exist to assist young Hispanic/Latino survivors in re-negotiating life goals and regulating cancer-related emotions and none focus on reducing the burden of morbidity via biobehavioral mechanisms.

Young or "emerging" adulthood is a period marked by goal attainment. Chronic illness experienced as "off time" in the lifespan interrupts goal pursuits and threatens valued life directions. As young adults return to goal pursuits, re-entry to post-cancer life can be a critical point in the survivorship trajectory. Behavioral intervention at this time is well positioned to confer longer-term impact. Emergent from our group's preliminary research, the investigators developed and pilot-tested Goal-focused Emotion-Regulation Therapy (GET) as 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. GET is a promising candidate intervention to address the mechanisms likely complicating the resolution of cancer-related burden.

Responsive the need for feasible, effective, and scalable interventions that meet the need of ethnic minority survivors, 100 Hispanic/Latino young adults (ages 18-39) with cancer will receive 6 sessions of GET or ISL. Our team will evaluate primary and secondary outcomes at baseline, post-treatment, and 3-month follow-up. The investigators predict that GET will be associated with superior distress outcomes and comparatively greater reductions in adverse biobehavioral indicators (dysregulated diurnal stress hormones, elevated systemic inflammation), and these advantages will be maintained at 3-months following intervention. The intervention will be delivered via an interactive video platform to enhance access. However, the investigators believe that GET could be optimized to meet the needs of this group. To this end, the investigators will examine the influence of Latino cultural processes (Familism, Machismo/Caballarismo, Simpatia, Acculturative Stress).

Findings will be used to adapt the GET intervention for a future randomized efficacy trial.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
measure: Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFαRII)
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
measure: Change in Salivary Diurnal Cortisol Daily Output
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Secondary outcomes:
measure: Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) Subscale Score
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
measure: Change in Career Thoughts Inventory (CTI) Global Score
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
measure: Change in Emotion Regulation Questionnaire (ERQ) Scale Scores
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
measure: Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
measure: Change in Emotional Approach Coping Questionnaire (EAC) Scale Scores
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
measure: Change in Salivary Diurnal Cortisol Slope
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
measure: Change in Salivary Diurnal Cortisol Awakening Response
timeFrame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Michael A Hoyt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.