A Biobehavioral Intervention to Reduce Adverse Outcomes in Young Adult Testicular Cancer Survivors

减少年轻成年睾丸癌幸存者不良后果的生物行为干预

• 批准号: 10736501
• 负责人: Michael A Hoyt
• 金额: $ 67.3万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-08 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10736501
• 关键词: Address; Adverse effects; Aftercare; Age; Behavior Therapy; Behavioral; Biological Factors; Biological Markers; Biological Sciences; California; Cancer Patient; Cancer Survivor; Chronic Disease; Clinic; Cohort Studies; Comprehensive Cancer Center; Confusion; County; DNA Methylation; Disease; Distress; Economics; Education; Emotional; Emotions; Epigenetic Process; Family; General Population; Genes; Glucocorticoid Receptor; Goals; Hormones; Hydrocortisone; Impairment; Individual; Inflammation; Informal Social Control; Interleukin-6; Interruption; Intervention; Late Effects; Life; Longevity; Malignant Neoplasms; Malignant neoplasm of testis; Measures; Mediation; Medical; Memorial Sloan-Kettering Cancer Center; Mental Depression; Morbidity - disease rate; NR3C1 gene; Oncology; Oranges; Outcome; Participant; Pattern; Pediatric Hospitals; Population; Positioning Attribute; Prevalence; Production; Psychological Factors; Race; Random Allocation; Randomized; Receptor Gene; Reproductive Health; Research; Resolution; Risk; Salivary; Second Primary Cancers; Sexuality; Stress; Survivors; Testing; Time; Treatment Side Effects; Urologic Oncology; Value of Life; Videoconferencing; Work; adverse outcome; anakinra; anxiety symptoms; biobehavior; cancer diagnosis; cancer therapy; career; comparative; depressive symptoms; design; effective intervention; efficacy evaluation; emerging adulthood; emotion regulation; experience; follow-up; improved; mood regulation; neoplasm registry; novel; pilot test; post intervention; primary outcome; psychologic; psychological distress; psychosocial; psychosocial adjustment; recruit; response; secondary outcome; serotonin transporter; side effect; skills; stress reactivity; success; survivorship; systemic inflammatory response; therapy design; video chat; young adult

Project Abstract 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 300 young adult (ages 18-39) testicular cancer patients to 6 sessions of GET or ISL (individual supportive listening), 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 inflammation), and these advantages will be maintained at three- and six-months following intervention. The intervention will be delivered via video conferencing to enhance access. An exploratory aim focuses on potential epigenetic vulnerabilities, to understand how environmental influences (via DNA methylation) on genes implicated in stress 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.

项目摘要 有检验的癌症诊断和治疗，特别是考虑到其对性和复制健康的威胁， 在年轻人的形成时期可能会令人痛苦。队列研究揭示了 检测癌症的抑郁症状超过一般人群。实际上，大多数年轻人 癌症的存活率将经历损害，痛苦和可修改的身体，行为和社会心理 初级医疗完成后很长一段时间持续存在的不良结果。这些包括 心理困扰，导航和追求人寿目标的损害，持续的副作用，提升 继发性恶性肿瘤和慢性病的风险以及生物行为伯嫩（例如，炎症增加， 影响发病率和与疾病相关的脆弱性的压力激素失调）。但是，很少 有针对性的有效干预措施，以帮助年轻生存重新谈判人生目标和监管 与癌症相关的情绪，没有一个专注于通过生物行为机制来减少发病率的燃烧。 年轻或“新兴”成年是目标达到目标的时期。慢性病经历了“ 时间”在寿命中，打断目标追求并威胁着有价值的生活方向。随着年轻人重返目标 追求，重新进入后癌的生活可能是生存轨迹的关键点。行为干预 目前，会议长期影响很高。从我们小组的初步研究中出现，我们 开发和试验性测试目标的情绪调节疗法（GET）是一种新颖的行为 干预措施通过提高目标导航技能，改善目的感来增强自我调节， 并更好地调节患有验证癌症的年轻人情绪反应的能力。获得是一个有前途的 候选干预措施以解决可能使癌症相关伯宁分辨率复杂化的机制。 响应对可行，有效和可扩展干预措施的需求，我们将随机分配300 年轻成年人（18-39岁）有证明癌症患者进行6个疗程或ISL（个人支持） 聆听），并在基线，治疗后，3个月的随访和评估初级和次要结果以及 6个月的随访。我们预测，Get将与出色的遇险结果和相对 提前减少生物行为指标（非调节的昼夜应力激素，升高 炎症），这些优势将在干预后仍在三个月和六个月内保持。 干预将通过视频会议进行，以增强访问。探索目的是 潜在的表观遗传脆弱性，以了解环境的影响（通过DNA甲基化）如何对 在压力和情绪调节中实施的基因与癌症的调整和干预反应有关。 这项研究利用了研究团队在生物行为肿瘤学和唾液方面的独特专业知识 生物科学测试针对年轻成人生存的新型行为干预。它有可能了解如何 改变近端行为，生物学和心理因素，强调长期不利影响。