Biobehavioral Intervention for Young Adult Testicular Cancer Survivors
This study is for young men, aged 18-39, who have completed chemotherapy for testicular cancer within the last four years and are experiencing distress. It aims to see if two different approaches can help reduce anxiety and depression, improve emotional well-being, and manage stress. You would receive either "Goal-Focused Emotion-Regulation Therapy (GET)" or "Individual Supportive Listening (ISL)" over eight weeks. Researchers will measure changes in your anxiety and depression levels, as well as stress-related markers in your blood and saliva, to understand how these interventions affect your well-being. The study is looking for 250 participants.
- Study design
- This is a randomized controlled study, meaning participants will be assigned by chance to one of two intervention groups. The study plans to enroll 250 men.
- What's involved
- You would participate in six sessions of either GET or ISL over eight weeks. Measurements will be taken at the start, immediately after the intervention, and then 3 and 6 months later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after the intervention is completed.
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A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
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), and to 6-month post-intervention (~32 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), and to 6-month post-intervention (~32 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 Slope and Daily OutputChange from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 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. Several indices will be computed including diurnal slope, area under the daily curve, cortisol awakening response, and total daily cortisol output.