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Clinical Trial 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 cancer survivors. 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.

Clinical Trial 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, we 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. We will evaluate primary and secondary outcomes at baseline, post-treatment, and 3-month follow-up. We 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, we believe that GET could be optimized to meet the needs of this group. To this end, we 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT06338475
Study type Interventional
Source University of California, Irvine
Contact Michael A Hoyt, PhD
Phone 949-824-5281
Status Not yet recruiting
Phase N/A
Start date May 1, 2024
Completion date June 2026

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