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临床试验/NCT04150848
NCT04150848Unknown2 期

A Biobehavioral Intervention for Young Men With Testicular Cancer: A Pilot Study

University of California, Irvine3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
100
试验地点
3
主要终点
Change in Hospital Anxiety and Depression Scale (HADS)

研究概览

简要总结

This study is a randomized controlled biobehavioral pilot trial designed to investigate the feasibility and preliminary efficacy of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET) aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients.

Participants will be randomized to receive six sessions of GET or Individual Supportive Therapy (ISP) delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1) and twelve weeks after intervention at T2. Additionally, identified biomarkers will be measured at baseline and at T2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • between the ages of 18 and 39 years at the time of consent
  • confirmed diagnosis of testis cancer (any stage)
  • completed chemotherapy for testis cancer within 2 years prior to consent
  • fluency in English (per self-report)
  • sub-optimal self-regulation as evidenced by a score of 1.8 or below on the Goal Navigation Scale or a score of 4 or greater on the Distress Thermometer (DT)

排除标准

  • lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder (per self-report)
  • active suicide plan
  • disorder that compromises comprehension of assessments or informed consent information
  • self-reported medical condition or medication use known to confound measures of systemic inflammation
  • daily smoking

结局指标

主要结局

Change in Hospital Anxiety and Depression Scale (HADS)

时间窗: Change from Baseline (T0) at 12-weeks Post-Intervention (T2)

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, CRP, sTNFαRII)

时间窗: Change from Baseline (T0) at intrervention completion, an average of 8 weeks

The investigators will focus on four biomarkers, IIL-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 Output

时间窗: Change from Baseline (T0) at intrervention completion, an average of 8 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. After data collection is complete, salivary cortisol will be analyzed with a time-resolved fluorescence immunoassay at the IISBR laboratory at UC Irvine. Several indices will be computed including diurnal slope, area under the daily curve, cortisol awakening response, and total daily cortisol output.

次要结局

  • Change in Emotion Regulation Questionnaire (ERQ) Scale Scores(Change from Baseline (T0) at 12-weeks Post-Intervention (T2))
  • Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score(Change from Baseline (T0) at 12-weeks Post-Intervention (T2))
  • Change in Career Thoughts Inventory (CTI) Global Score(Change from Baseline (T0) at 12-weeks Post-Intervention (T2))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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