A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer

Trial Title: A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer

NCT ID: NCT06338475

Condition: Cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Participant)

Intervention:

Intervention type: Behavioral
Intervention name: Goal-Focused Emotion-Regulation Therapy (GET)
Description: 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.
Arm group label: Goal-Focused Emotion-Regulation Therapy (GET)

Intervention type: Behavioral
Intervention name: Individual Supportive Listening (ISL)
Description: 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.
Arm group label: Individual Supportive Listening (ISL)

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.

Criteria for 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)

Gender: Male

Gender based: Yes

Gender description: This study tests an intervention developed specifically for male young adult cancer survivors.

Minimum age: 18 Years

Maximum age: 39 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of California, Irvine

Address:
City: Irvine
Zip: 92617
Country: United States

Status: Recruiting

Contact:
Last name: Michael Hoyt, PhD

Phone: 949-824-5281
Email: mahoyt@uci.edu

Start date: June 1, 2024

Completion date: June 2026

Lead sponsor:
Agency: University of California, Irvine
Agency class: Other

Source: University of California, Irvine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06338475