Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Effects

早期与晚期癌症姑息治疗：临床和生物行为效应

• 批准号: 7846065
• 负责人: Marie Anne Bakitas
• 金额: $ 47.4万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7846065
• 关键词: Address; Advanced Malignant Neoplasm; Advanced Practice Nurse; Affect; American; Bereavement; Biological; Biological Markers; Blood; Blood specimen; Brain; Cancer Patient; Caregiver Burden; Caregivers; Caring; Cessation of life; Chronic Disease; Chronic stress; Clinical; Clinical Research; Communication; Comprehensive Cancer Center; Control Groups; Decision Making; Demographic Factors; Diagnosis; Discipline; Disease; Educational Curriculum; Effectiveness of Interventions; Elements; Enrollment; Ensure; Family; Funding; Goals; Grief reaction; Guidelines; Healthcare Systems; Hematologic Neoplasms; Hematology; Hydrocortisone; Immune; Immunity; Incidence; Institute of Medicine (U.S.); Institutes; International; Intervention; Interview; Knowledge; Life; Lymphocyte Subset; Malignant Neoplasms; Measures; Mediating; Mediator of activation protein; Modeling; Moods; NCI-Designated Cancer Center; Newly Diagnosed; Online Systems; Outcome; Outcome Study; Palliative Care; Palliative Care Nursing; Participant; Patient Care; Patients; Pattern; Persons; Plasma; Population; Prevention; Primary Health Care; Problem Solving; Proxy; Quality of Care; Quality of life; Quality-of-Life Assessment; Questionnaires; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Recurrence; Recurrent Malignant Neoplasm; Reporting; Risk; Rural; Rural Population; Saliva; Salivary; Sampling; Self Care; Solid Neoplasm; Stress; Surveys; Symptoms; Telephone; Terminal Disease; Testing; Time; Training; Value of Life; Wood material; Work; base; behavior change; biobehavior; biological adaptation to stress; biopsychosocial; cancer palliative treatment; chronic care model; clinical care; coping; cytokine; depressive symptoms; empowered; empowerment; end of life; end of life care; evidence based guidelines; expectation; experience; follow-up; hazard; immune function; improved; intervention effect; oncology; outcome forecast; palliative; patient oriented; post intervention; preference; prevent; programs; psychosocial; public health relevance; quality of death; skills; symptom management; treatment as usual

DESCRIPTION (provided by applicant): In 2008, cancer claimed more than 565,000 American lives -1,500 people a day. Palliative care strives to improve quality of life (QOL) and to prevent "bad deaths" by providing expert, interdisciplinary care to manage the effects of disease and treatment. Effective end-of-life (EOL) care depends upon proactive, patient-centered interventions to prepare patients and families for the challenges of terminal illness. We were able to demonstrate feasibility and efficacy of a concurrent oncology palliative care (COPC) intervention; however, a number of gaps in our knowledge remain. The proposed study is a logical extension of that work. This randomized controlled clinical trial will determine whether a COPC intervention (introduced immediately or 12 weeks after diagnosis) can improve clinical outcomes and end-of-life (EOL) care for patients with advanced cancer and their caregivers. We will also examine potential mechanisms, mediators, and moderators whereby the intervention has its effects. Exploratory aims will investigate the feasibility of recruiting patients with less common solid tumors and hematological malignancies, the patterns of stress and immune biomarkers, and the biomarkers' relationship to QOL, mood, symptoms, and survival. Patients will be randomized to begin the intervention either immediately or 12 weeks after a new diagnosis of advanced or recurrent cancer. This phone-based intervention consists of: 1) an Advanced Practice Palliative Care Nurse Interventionist instituting 1a) a 6-session manualized patient curriculum- Charting Your Course, 1b) a 4-session manualized, caregiver curriculum- the COPE program, and 1c) on-going patient and caregiver follow up; and 2) Palliative Care Team Comprehensive Assessment & Management. Patients will complete baseline questionnaires about QOL, depression, and symptoms. Caregivers will complete questionnaires on caregiver burden, and grief. Questionnaires will be completed using a web-based portal at 6, 12, and 18 weeks, and every 12 weeks thereafter until the patients' death or study completion. Three months after a participant's death, caregivers will be asked to complete an after death questionnaire about the quality of care the patient received while dying. Saliva and blood samples will be collected at baseline and 12 and 24 weeks from patients who choose to participate in the study to examine biomarkers of stress and immune function. Quantitative and qualitative analyses will be performed to determine EOL outcomes of early vs. later entry into palliative care. PUBLIC HEALTH RELEVANCE: In 2008, cancer claimed more than 565,000 American lives -1,500 people a day. This study will determine whether a concurrent model of palliative cancer care (introduced at diagnosis or 12 weeks after diagnosis) can improve end-of-life (EOL) care for patients with advanced cancer. We will ask patients to complete surveys on quality of life, depression, and symptoms and we will ask their caregivers to complete surveys on burden and the quality of care the patient received while dying. In addition, we will ask some patients to provide blood and saliva samples to determine if this care affects their biological immunity and stress responses. Findings from this study could help to determine guidelines and improve EOL care for underserved, vulnerable cancer patients.

描述（由申请人提供）：2008年，癌症每天夺取56.5万多人的生活-1,500人。姑息治疗努力通过为专家，跨学科的护理来管理疾病和治疗的影响，以改善生活质量（QOL）并防止“不良死亡”。有效的生命终止（EOL）护理取决于主动，以患者为中心的干预措施，以准备患者和家庭应对绝症的挑战。我们能够证明并发肿瘤学护理（COPC）干预的可行性和功效；但是，我们的知识仍然存在许多差距。拟议的研究是该工作的逻辑扩展。这项随机对照临床试验将确定COPC干预（立即引入或诊断后12周）可以改善晚期癌症及其护理人员患者的临床结局和临终关心（EOL）护理。我们还将检查潜在的机制，调解者和主持人，从而有其影响。探索目的将调查招募较不常见的实体瘤和血液系统恶性肿瘤的患者的可行性，压力和免疫生物标志物的模式，以及生物标志物与QOL，情绪，症状和生存的关系。患者将在新诊断晚期或复发性癌症后立即或12周开始干预。这项基于电话的干预措施包括：1）先进的姑息治疗护士干预主义者1A）1A）一项六阶段的手动患者课程 - 图表您的课程，1B）一项4条经营的手动手动，护理人员课程 - COPE课程和1C）持续的患者和护理人员和护理人员的随访； 2）姑息治疗团队全面评估与管理。患者将完成有关QOL，抑郁和症状的基线问卷。看护人将完成有关照料者负担和悲伤的问卷。问卷将在6、12和18周时使用基于Web的门户进行完成，此后每12周一次，直到患者的死亡或学习完成为止。参与者死后三个月后，将要求看护人填写有关患者在垂死时接受的护理质量的死后问卷。唾液和血液样本将在基线和12和24周的患者中收集，他们选择参加研究以检查压力和免疫功能的生物标志物。将进行定量和定性分析，以确定早期的EOL结局，而后来进入姑息治疗。 公共卫生相关性：2008年，癌症每天夺走了56.5万多人的生活-1,500人。这项研究将确定姑息治疗癌症护理的并发模型（诊断或诊断后12周引入）是否可以改善晚期癌症患者的寿命（EOL）护理。我们将要求患者完成有关生活质量，抑郁和症状的调查，我们将要求他们的护理人员完成有关患者死亡时接受的负担和护理质量的调查。此外，我们将要求一些患者提供血液和唾液样本，以确定此护理是否影响其生物免疫和压力反应。这项研究的结果可以帮助确定指南，并改善服务不足的脆弱癌症患者的EOL护理。