A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of California, Irvine
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Salivary Diurnal Cortisol Daily Output
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Michael Hoyt
Professor
University of California, Irvine
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)
Outcomes
Primary Outcomes
Change in Salivary Diurnal Cortisol Daily Output
Time Frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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 in Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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 in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFαRII)
Time Frame: Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks)
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.
Secondary Outcomes
- 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 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 Emotional Approach Coping Questionnaire (EAC) Scale Scores(Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks))
- Change in Salivary Diurnal Cortisol Slope(Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks))
- Change in Salivary Diurnal Cortisol Awakening Response(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))