Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer
This study is testing two behavioral interventions for Latino/Hispanic young adults (ages 18-39) who have had cancer. The interventions are called Goal-Focused Emotion-Regulation Therapy (GET) and Individual Supportive Listening (ISL). Researchers want to see if these interventions can improve anxiety and depression, reduce inflammation (measured by cytokine levels), and help regulate stress hormones (measured by salivary cortisol). You might be able to join if you are a male, 18-39 years old, identify as Hispanic/Latino, have a cancer diagnosis, and speak English or Spanish. The study is currently recruiting 100 participants, but its overall status is unclear.
- Study design
- This is an interventional study with 100 planned participants. Participants will be randomly assigned to receive either Goal-Focused Emotion-Regulation Therapy (GET) or Individual Supportive Listening (ISL).
- What's involved
- You would participate in six sessions of either GET or ISL over eight weeks. You would also have measurements taken at the start, after 8 weeks, and again 3 months later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 months after the intervention is completed.
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A Biobehavioral Intervention for Latino/Hispanic Young Adults with Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Michael A Hoyt, PhD · PRINCIPAL_INVESTIGATOR · University of California, Irvine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Hospital Anxiety and Depression Scale (HADS)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)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.
- Change in Salivary Diurnal Cortisol Daily OutputChange 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.