Giving and receiving: A reciprocal support writing intervention to reduce symptoms during stem cell transplant

给予和接受：相互支持写作干预，以减轻干细胞移植期间的症状

基本信息

批准号：
9750307
负责人：
Christine Rini
金额：
$ 45万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-01 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9750307
关键词：
Acute Address Advanced Development Advocacy Algorithms Antineoplastic Agents Behavior Therapy Cancer Patient Cancer Survivor Caregivers Cognitive Communities Computers Data Development Disease Distress Drug usage Emotional Ethics Ethnic Origin Evaluation Fatigue Focus Groups Future Goals Health Personnel Hematologic Neoplasms Hospitalization Individual Intervention Malignant Neoplasms Mediator of activation protein Methods Online Systems Outcome Pain Participant Pathway interactions Patient Care Patient Recruitments Patients Performance Status Pilot Projects Population Prevalence Public Health Quality of life Race Randomized Randomized Controlled Trials Recovery Research Resources Severities Stem cell transplant Structure Subgroup Survivors Symptoms Testing Therapeutic Time Transplant Recipients Transplantation Writing active control acute symptom arm attentional control base clinically relevant clinically significant cost cost effectiveness design disability evidence base experience expressive writing follow up assessment health goals improved insight novel patient oriented patient subsets peer peer support persistent symptom physical symptom post intervention post-transplant prevent primary outcome programs prototype psychologic psychological distress psychological symptom recruit reduce symptoms secondary outcome sex showing emotion social theories transplant survivor trial comparing usability

项目摘要

Use of stem cell transplant (mostly for hematologic cancers) is expected to increase 5-fold by 2030, when the number of survivors will reach 500,000. This highly toxic treatment causes a range of acute physical and psychological symptoms (e.g., pain, fatigue, distress) which then persist for years for up to 45% of patients. To address gaps in existing symptom-focused behavioral interventions that can be added to standard patient care, we developed Expressive Helping (EH), a low-cost, low-burden intervention that targets a range of physical and psychological symptoms in a broad group of transplant recipients. EH includes 2 therapeutic components, completed in 4 brief structured writing sessions over 4 weeks: 3 sessions of Pennebaker’s emotionally expressive writing followed by 1 session of theory- and evidence-based “peer support” writing in which patients use insights from expressive writing to write an account of their transplant experience that is meant to be shared to help people preparing for or undergoing transplant. In a randomized controlled trial (RCT) comparing EH to 3 active control arms in long-term transplant survivors, EH reduced physical symptoms and distress in survivors with moderate to severe persistent symptoms. Because symptoms are elevated for most patients as they undergo transplant, and early symptoms predict persistent symptoms, we now propose to determine whether EH can be used during transplant to reduce common acute symptoms and prevent development of persistent symptoms. Further, EH was designed to be part of a complementary, 2-part “reciprocal benefits of helping” intervention strategy based on evidence that patients can benefit both from getting experiential information about transplant from other patients’ peer support narratives and from providing peer support by completing EH. We therefore propose to begin development and evaluation of a web-based supportive resource to deliver peer support narratives from EH to patients preparing for and undergoing transplant. Thus, in Aim 1 we propose to conduct a 2-arm RCT to evaluate the efficacy of EH when used in the early post- transplant period. Participants will be 315 cancer patients with at least moderate symptoms, recruited pre- transplant and randomized to EH or a neutral writing (NW) time and attention control arm. They will complete their assigned writing from the first week of hospitalization to 2 weeks post-discharge and be followed for 12- months to evaluate effects on symptom burden (primary outcome) and psychological distress, quality of life, and performance status (secondary outcomes). In Aim 2 we will evaluate potential intervention mechanisms (theorized causal pathways) and moderators. In Aim 3 we will develop and evaluate optimal methods for delivering peer support narratives from EH to patients preparing for or undergoing transplant, guided by data from trial participants, a community advisory board of key stakeholders, focus groups, and usability testing. This proposed integrated approach is novel and holds promise as a disseminable and clinically-relevant intervention strategy for reducing acute and persistent symptoms in stem cell transplant recipients.

到 2030 年，干细胞移植（主要用于血液癌症）的使用预计将增加 5 倍，届时幸存者人数将达到50万，这种剧毒治疗会导致一系列急性身体和疾病。高达 45% 的患者会出现心理症状（例如疼痛、疲劳、痛苦），并持续数年。解决现有以症状为中心的行为干预措施中的差距，这些干预措施可以添加到标准患者护理中，我们开发了表达性帮助 (EH)，这是一种低成本、低负担的干预措施，针对一系列身体问题 EH 包括 2 个治疗成分，在 4 周内完成 4 个简短的结构化写作课程：3 个彭尼贝克情感课程表达性写作，然后是 1 节基于理论和证据的“同伴支持”写作，其中患者利用表达性写作的见解来描述他们的移植经历在一项随机对照试验 (RCT) 中进行比较，以帮助人们准备或接受移植。 EH 为长期移植幸存者提供 3 个主动控制臂，EH 减少了患者的身体症状和痛苦具有中度至重度持续症状的幸存者，因为大多数患者的症状会加重。他们接受移植，早期症状预示着持续症状，我们现在建议确定是否可以在移植期间使用 EH 来减少常见的急性症状并预防发生此外，EH 被设计为互补的、两部分“互惠互利”的一部分。帮助”干预策略基于证据表明患者可以从获得体验中受益有关移植的信息来自其他患者的同伴支持叙述以及通过提供同伴支持因此，我们建议开始开发和评估基于网络的支持。提供从 EH 到患者准备和接受移植的同伴支持叙述的资源。在目标 1 中，我们建议进行 2 组 RCT，以评估 EH 在术后早期使用时的功效。参与者将是 315 名至少有中度症状的癌症患者，在移植前招募。移植并随机分配到 EH 或中性写作 (NW) 时间和注意力控制组，他们将完成。他们从住院第一周到出院后两周的指定写作，并跟踪 12- 几个月来评估对症状负担（主要结果）和心理困扰、生活质量的影响，在目标 2 中，我们将评估潜在的干预机制。在目标 3 中，我们将开发和优化评估方法。在数据指导下，向准备或接受移植的患者提供来自 EH 的同伴支持叙述来自试验参与者、主要利益相关者的社区咨询委员会、焦点小组和可用性测试。这种提出的综合方法是新颖的，有望作为一种可传播且与临床相关的方法减少干细胞移植受者急性和持续症状的干预策略。