Psycho-Spiritual Management for Patients with Advanced Cancer and their Family Caregivers

晚期癌症患者及其家庭照顾者的心理精神管理

• 批准号: 10734689
• 负责人: Kathrin Milbury
• 金额: $ 69.41万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-11 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10734689
• 关键词: Address; Advanced Malignant Neoplasm; Affect; Area; Attention; Behavior; Behavioral Medicine; Behavioral Sciences; Cancer Family; Cancer Patient; Caregivers; Caring; Cessation of life; Community Hospitals; Control Groups; Data; Devices; Diagnosis; Disease; Disease Progression; Disseminated Malignant Neoplasm; Distress; Dose; Emotional; Enrollment; Ensure; Exercise; Family; Family Caregiver; Feeling hopeless; Feeling suicidal; Fostering; Fright; Future; Goals; Hospice Care; Immunotherapy; Intervention; Intervention Studies; Knowledge; Latino; Life; Literature; Malignant Neoplasms; Manuals; Measurement; Meditation; Mental Depression; Methods; Nature; Outcome; Palliative Care; Participant; Patient Care; Patient Self-Report; Patients; Personal Satisfaction; Population; Population Heterogeneity; Procedures; Prognosis; Psychology; Psychosocial Assessment and Care; Randomized; Randomized, Controlled Trials; Sampling; Self Assessment; Site; Social support; Solid; Spirituality; Supportive care; Symptoms; Techniques; Translating; Translations; Treatment Efficacy; Videoconferencing; Work; arm; attentional control; cancer therapy; clinical care; comparison group; coping; depressive symptoms; efficacious intervention; efficacy trial; emotional disclosure; end of life; end of life care; evidence base; experience; follow-up; high risk; hospital care; improved; in vivo; innovation; negative affect; novel; patient population; peace; pilot test; positive emotional state; preference; primary outcome; prognostic value; programs; psychologic; psychological distress; psychosocial; recruit; secondary outcome; stressor; tool; treatment arm; treatment as usual; trial comparing; usual care arm

PROJECT SUMMARY/ABSTRACT Given the generally incurable nature of metastatic cancer, patients and their family caregivers are at high risk of experiencing depressive symptoms and spiritual distress (e.g., lack of meaning and peace, despair, alienation). As caregivers struggle with their own fears and stressors, providing quality support and care to the patient may be difficult. Moreover, psychospiritual distress is interdependent in families coping with cancer suggesting the need for a dyadic approach to psychospiritual supportive care. Despite accumulating evidence that highlights the value of positive psychology interventions in improving depressive symptoms and spiritual wellbeing, evidence-based dyadic interventions are limited in the palliative care setting. To address critical knowledge gaps and build upon our pilot work, we propose an adequately powered efficacy trial of a 4-session family-focused meditation (FFM) intervention targeting psychospiritual outcomes. Patient-family caregiver dyads will be randomized to either the FFM intervention, a usual care (UC) control group or a dose-matched attention control (AC) group receiving a social support intervention. To enhance accessibility and scalability for future dissemination, the FFM and AC interventions will be delivered via videoconferencing. To increase generalizability of our findings, we will use a multi-site enrollment strategy and recruit families from a community hospital caring for a diverse including underserved patient population. We will administer all study procedures including the Patients and caregivers will complete assessments at baseline (prior to randomization) and then again 6, 12, and 24 weeks later. Guided by our exciting pilot findings, we propose a multi-method assessment strategy to uncover a priori intervention mechanisms. In addition to self-reports, at baseline and the 6-week follow-up, patients and caregivers will wear a device called the Electronically Activated Recorder (EAR), an innovative, in vivo naturalistic observation tool that will allow us to objectively assess changes in observed behaviors in daily life as a function of group assignment to evaluate mechanisms of intervention efficacy. We propose depressive symptoms as the primary outcome given the prognostic value of depression in the survival of metastatic cancer patients and family caregivers; and spiritual wellbeing as the secondary outcome as it protects against the desire for a hastened death, hopelessness, and suicidal ideation independent of depression in patients with metastatic cancer. For families who transition to end of life care over the course of the study, we seek to explore their experiences with this transition and if the FFM program improves patient and caregiver psychospiritual adjustment at this crucial timepoint. The knowledge gained from this randomized controlled trial will advance the science of behavioral medicine, and, ultimately, inform the clinical care of a vulnerable and understudied patient-caregiver population. intervention in English or Spanish based on participant preference.

项目概要/摘要 鉴于转移性癌症通常无法治愈，患者及其家庭护理人员面临着很高的风险 经历抑郁症状和精神困扰（例如，缺乏意义和平静、绝望、疏远）。 当护理人员与自己的恐惧和压力作斗争时，为患者提供优质的支持和护理可能会 很难。此外，在应对癌症的家庭中，心理精神困扰是相互依赖的，这表明 需要采用二元方法进行精神精神支持护理。尽管越来越多的证据表明 积极心理学干预在改善抑郁症状和精神健康方面的价值， 基于证据的二元干预措施在姑息治疗环境中受到限制。解决关键知识差距 并在我们的试点工作的基础上，我们提出了一项以家庭为中心的 4 个疗程的充分功效试验 针对心理精神结果的冥想（FFM）干预。患者与家属护理人员二人组将 随机分配至 FFM 干预组、常规护理 (UC) 对照组或剂量匹配注意力对照组 (AC) 组接受社会支持干预。增强未来的可访问性和可扩展性 传播方面，实况调查团和审计委员会将通过视频会议进行干预。提高普遍性 根据我们的研究结果，我们将采用多地点招募策略，并从社区医院招募家庭来照顾 为包括服务不足的患者群体在内的多元化患者群体提供服务。我们将管理所有研究程序，包括 患者和护理人员将完成 在基线（随机化之前）进行评估，然后在 6、12 和 24 周后再次进行评估。在我们的指导下 令人兴奋的试点结果，我们提出了一种多方法评估策略来发现先验干预 机制。除了自我报告之外，在基线和 6 周随访时，患者和护理人员还将佩戴 一种称为电子激活记录器 (EAR) 的设备，一种创新的体内自然观察工具 这将使我们能够客观地评估日常生活中观察到的行为变化作为群体的功能 分配评估干预效果的机制。我们建议将抑郁症状作为主要症状 考虑到抑郁症对转移性癌症患者及其家人的生存预后价值的结果 照顾者；精神健康作为次要结果，因为它可以防止急于求成的愿望 转移性癌症患者的死亡、绝望和自杀意念与抑郁无关。为了 在研究过程中过渡到临终关怀的家庭，我们试图探索他们的经历 这种转变以及 FFM 计划是否能在这一关键时刻改善患者和护理人员的心理精神调整 时间点。从这项随机对照试验中获得的知识将推动行为科学的发展 医学，并最终为弱势且未被充分研究的患者护理人员群体的临床护理提供信息。 根据参与者的偏好使用英语或西班牙语进行干预。