A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 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 efficacy trial designed to investigate the feasibility and acceptability 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 Listening (ISL) 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), twelve weeks after intervention (T2) and 24 weeks after the intervention (T3). Additionally, identified biomarkers will be measured at baseline and at T1, T2, and T3.
详细描述
Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood. Cohort studies reveal the prevalence of depressive symptoms in testicular cancer exceeds the general population. 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, effective interventions exist to assist young 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, we 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, we will randomly allocate 250 young adult (ages 18 -39) testicular cancer patients to 6 sessions of GET or ISL, and evaluate primary and secondary outcomes at baseline, post-treatment, 3-month follow-up, and 6-months follow-up. We 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 three- and six-months following intervention. The intervention will be delivered via an interactive video platform to enhance access. An additional exploratory aim focuses on potential epigenetic vulnerabilities, to understand how environmental influences (via DNA methylation) on genes implicated in stress reactivity and mood regulation are related to cancer adjustment and intervention response.
This study capitalizes on the study team's unique expertise in biobehavioral oncology and salivary bioscience to test a novel behavioral intervention for young adult survivors. It has potential to understand how to alter proximal behavioral, biological, and psychological factors that underscore long term adverse effects.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 39 years at time of consent
- •A confirmed diagnosis of testis cancer (any stage)
- •Completion of chemotherapy for testis cancer within 4 years prior to consent
- •A score of >4 on the Distress Thermometer
- •English fluency, as per medical record documenting preferred language or in the judgment of the investigator
- •Spanish fluency, as per medical record documenting preferred language or in the judgment of the investigator
- •Able to perform informed consent
排除标准
- •Lifetime history of psychiatric of cognitive disturbance as per self-report or medical record
- •In the judgment of the consenting professional, is unable to provide informed consent and complete study sessions and assessment
- •As per self-report, has medical conditions that affect the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; Type I diabetes; acute hepatitis; recent vaccination for viral disease)
- •Regular smoker (daily use)
结局指标
主要结局
Change in Hospital Anxiety and Depression Scale (HADS)
时间窗: 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)
时间窗: 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 Output
时间窗: Change 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.
次要结局
- 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), and to 6-month post-intervention (~32 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), and to 6-month post-intervention (~32 weeks))
- Change in Career Thoughts Inventory (CTI) Global Score(Change from Baseline (T0) to intervention completion (~8 weeks), to 3-month post-intervention (~20 weeks), and to 6-month post-intervention (~32 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), and to 6-month post-intervention (~32 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), and to 6-month post-intervention (~32 weeks))
研究者
Michael Hoyt
Associate Professor
University of California, Irvine