Dignity Therapy RCT led by Nurses or Chaplains for Elderly Cancer Outpatients

由护士或牧师领导的针对老年癌症门诊患者的尊严治疗随机对照试验

• 批准号: 9125588
• 负责人: LINDA Leah EMANUEL
• 金额: $ 71.25万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-20 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9125588
• 关键词: Address; Affect; Awareness; Cancer Patient; Cancer Prognosis; Caring; Cessation of life; Client satisfaction; Data; Discipline; Distress; Elderly; Elements; Evaluation; Freedom; Goals; Health Professional; Health Services Research; Intervention; Life; Love; Malignant Neoplasms; Manuscripts; Measures; Modeling; Nurses; Outcome; Outcome Measure; Outpatients; Palliative Care; Palliative Care Nursing; Patient-Focused Outcomes; Patients; Personal Satisfaction; Pilot Projects; Preparation; Process; Process Measure; Provider; Psyche structure; Randomized; Randomized Controlled Trials; Reporting; Research; Sampling; Services; Site; Symptoms; Testing; Time; Work; arm; cancer diagnosis; design; efficacy testing; emotional symptom; improved; intervention effect; older patient; oncology; palliative; peace; physical symptom; preference; psychosocial; public health relevance; satisfaction

 DESCRIPTION (provided by applicant): Our long-term goal is to improve spiritual care outcomes for elderly patients facing a cancer diagnosis. We will use a nurse-led or chaplain-led intervention, Dignity Therapy (DT), focused on dignity conservation tasks such as settling relationships, sharing words of love, and preparing for separation by death. These tasks are central needs for elderly patients with cancer, but it is not clear if DT should be led by nurses o chaplains, the two disciplines within palliative care most available to provide DT. We propose a 3-arm, pre/posttest, randomized, controlled 4-step, stepped-wedge design to compare the effects of usual outpatient palliative care and usual outpatient palliative care along with either nurse-led or chaplain-led DT on pilot tested patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness). We will include 560 elderly patients with cancer from 6 outpatient palliative care services across the U.S. We will assign the 6 sites to usual care in the first-step period (12 months), and randomly assign 2 sites per step to begin and continue DT led either by a nurse or a chaplain during each of the next three steps. During usual care steps, 280 patients will complete pretest measures (patient outcomes, processes, covariates [physical symptoms, spiritual distress]), receive usual chaplain care, and 4-6 weeks later will complete posttest measures. During experimental steps as part of routine palliative care, 280 patients will complete pretest measures, receive nurse-led or chaplain-led DT, and 4-6 weeks later will complete posttest measures. Process measures will be completed during all steps. Using mixed level analysis with site, provider (nurse, chaplain), and time (step) included in the model, we wil compare the usual care and DT groups for effects on patient outcomes and spiritual care processes and determine the moderating effects of physical symptoms and spiritual distress. Specific aims are to: Aim 1 Compare usual palliative care and usual palliative care with DT (nurse-led, chaplain-led) groups for effects on: a) patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness). We hypothesize that, controlling for pretest scores, each of the DT groups will have higher scores on the dignity impact and existential tasks measures than the usual care group; each of the DT groups will have better peaceful awareness and treatment preference more consistent with their cancer prognosis than the usual care group; and b) processes of delivering palliative spiritual care services (satisfaction, unmet spiritual needs). We hypothesize that the DT groups will show increased patient satisfaction with spiritual care services and fewer unmet spiritual needs compared to the usual care group. Aim 2 Explore the influence of physical symptoms and spiritual distress on the dignity impact and existential tasks effects of usual palliative care and nurse-led or chaplain-led DT. We hypothesize that physical symptoms and spiritual distress will significantly affect intervention effects. This rigorous trial of DT will constitute a landmark step in palliative care and spiritual health services research.

 描述（由申请人提供）：我们的长期目标是改善面临癌症诊断的老年患者的精神护理结果。我们将使用护士主导或牧师主导的干预，尊严疗法（DT），专注于尊严保护任务，如解决关系，分享爱的话语，并为死亡分离做好准备。这些任务是老年癌症患者的核心需求，但目前尚不清楚DT是否应由护士或牧师领导，这两个学科在姑息治疗中最适合提供DT。我们提出了一个3臂、前/后测试、随机、对照4步、阶梯楔形设计，以比较常规门诊姑息治疗和常规门诊姑息治疗沿着护士主导或牧师主导的DT对试点测试患者结局（尊严影响、存在任务和癌症预后意识）的影响。我们将纳入来自美国6个门诊姑息治疗服务的560名老年癌症患者。 第一步阶段（12个月），每一步随机分配2个研究中心，在接下来的三个步骤中的每一个步骤中开始并继续由护士或牧师领导的DT。在常规护理步骤中，280名患者将完成预测试测量（患者结局、过程、协变量[身体症状、精神痛苦]），接受常规牧师护理，4-6周后将完成后测试测量。在作为常规姑息治疗一部分的实验步骤中，280名患者将完成预测试措施，接受护士或牧师领导的DT，4-6周后将完成后测试措施。将在所有步骤中完成工艺措施。使用混合水平分析与网站，提供者（护士，牧师），和时间（步骤）包括在模型中，我们将比较常规护理和DT组对患者的结果和精神护理过程的影响，并确定身体症状和精神困扰的调节作用。具体目标是：目的1比较常规姑息治疗和常规姑息治疗与DT（护士领导，牧师领导）组对患者结局（尊严影响，存在任务和癌症预后意识）的影响。我们假设，控制预测试分数，每个DT组将有更高的分数的尊严的影响和存在的任务措施比常规护理组;每个DT组将有更好的和平意识和治疗偏好更符合他们的癌症预后比常规护理组;和B）提供姑息性精神护理服务的过程（满意度，未满足的精神需求）。我们假设，DT组将显示出更高的患者满意度与精神护理服务和更少的未满足的精神需求相比，通常的护理组。目的2探讨躯体症状和精神痛苦对常规姑息治疗和护士或牧师主导的姑息治疗的尊严影响和生存任务效果的影响。我们假设，身体症状和精神困扰会显着影响干预效果。这种严格的DT试验将构成姑息治疗和精神治疗的里程碑式的一步。 卫生服务研究。