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（由应用提供）：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。我们将使用由护士主导的或牧师主导的干预，尊严治疗（DT），重点是尊严保护任务，例如建立关系，分享爱的话以及为死亡分离做准备。这些任务是老年癌症患者的核心需求，但是尚不清楚DT是否应由护士O牧师领导，这是姑息治疗中最可用于提供DT的两个学科。 We will include 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, existing tasks, and cancer progression awareness).我们将包括560名来自美国6个门诊姑息治疗服务的癌症患者 第一步期（12个月），在接下来的三个步骤中的每个步骤中，每个步骤随机分配2个站点以开始并继续由护士或牧师领导。在通常的护理步骤中，280名患者将完成预测量测量（患者结果，过程，协变量[身体症状，精神痛苦]），接受常规的牧师护理，4-6周后将完成后测测量。在实验步骤中，作为常规姑息治疗的一部分，有280名患者将完成预测试措施，接受护士为主导或牧师主导的DT，4-6周后，将完成后测措施。过程措施将在所有步骤中完成。我们将使用现场，提供商（护士，牧师）和模型中包含的时间（步骤）进行混合级别的分析，我们将比较通常的护理和DT组，以实现对患者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。具体目的是：AIM 1与DT（由护士领导的，由牧师主导的）组相比，将常规的姑息治疗和通常的姑息治疗对：我们假设，在控制预测试分数的情况下，每个DT组的尊严影响和现有任务措施的分数将比通常的护理组更高。与通常的护理组相比，每个DT组的和平意识和治疗偏好与癌症的预后更一致。 b）提供姑息精神护理服务的过程（满意，未满足的精神需求）。我们假设与通常的护理小组相比，DT组将表现出患者对精神护理服务的满意度提高，未满足的精神需求更少。 AIM 2探讨了身体症状和精神困扰对尊严影响和现有任务的影响，通常由姑息治疗和由护士主导或由牧师主导的DT的影响。我们假设身体症状和精神困扰将显着影响干预效果。 DT的严格试验将构成姑息治疗和精神的地标步骤。 卫生服务研究。