Recovery Support for Bladder CA Patients and Caregivers: A Multimodal Approach

膀胱 CA 患者和护理人员的康复支持：多模式方法

基本信息

批准号：
10436957
负责人：
Michael A Diefenbach
金额：
$ 56.7万
依托单位：
FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
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：
2018-07-01 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10436957
关键词：
Address Aftercare Age Area Attention Bladder Body Image Cancer Intervention Cancer Patient Caregivers Caring Categories Climacteric Clinical Combined Modality Therapy Complex Data Data Analyses Development Diagnosis Disease Distress Emergency Care Emergency Nursing Emergency department visit Evaluation Excision Face Feeling Female Fright Future Gender Goals Health Professional Health Promotion Home visitation Hospitals Ileal conduit procedure Infection Information Resources Instruction Intervention Knowledge Learning Literature Maintenance Malignant neoplasm of urinary bladder Mediating Mediator of activation protein Medical Modeling Online Systems Operative Surgical Procedures Participant Patient Care Patients Persons Phase Physicians Pilot Projects Preparation Prostate Publishing Quality of life Randomized Randomized Controlled Trials Recovery Recovery Support Recurrence Regimen Research Research Methodology Sampling Savings Self Care Self Efficacy Spouses Stomas System Technology Testing Time Treatment Efficacy Visit Visiting Nurse Work base caregiving clinical application clinical care comparison group cost cost effective experience group intervention health training implementation cost improved innovation intervention cost intervention effect lymph nodes multimodality muscle invasive bladder cancer novel primary outcome programs psychologic psychosocial readmission rates secondary outcome skills social standard of care survivorship therapy design usability web-based intervention

项目摘要

ABSTRACT Treatment for muscle invasive bladder cancer (MIBC) involves the removal of the bladder and construction of a new voiding system and is physically and psychologically profoundly challenging for patients and caregivers. Based on our published literature and extensive pilot data, patients and caregivers have extensive unmet informational, social, psychological, instrumental, and medical needs from the time of diagnosis, through treatment and recovery which are not adequately addressed by health care professionals. We propose to address these unmet needs through the refinement and evaluation of a comprehensive, 2-part (in-person and web-based) intervention, geared towards the patient and caregiver. Specifically, during Aim 1, the formative phase, we propose to further refine our newly developed intervention components with the help of an established patient/caregiver advisory board. The intervention, Recovery Support for Bladder Cancer (RSBC), consists of a pre-treatment, in-person preparatory instructional session with a trained health care professional (Module 1) to equip patients and caregivers with the skills to adjust to the upcoming treatment and recovery period. This is followed by a post-treatment, interactive web-based program (Module 2) to provide further support for both patients and caregivers to enhance quality of life (QOL) and reduce infections and nurse/ER visits. The RSBC intervention will be evaluated in a 12-month randomized controlled trial (Aim 2) among patients and caregiver dyads (N=330 initial; 230 final sample) against a time and attention comparison condition that incorporates standard of care discharge instructions and modules focusing on wellness. Primary outcomes for both patients and caregivers will be improved QOL, which is hypothesized to be significantly higher among participants randomized into RSBC. Secondary outcomes will be fewer infections and nurse- ER visits for patients randomized into RSBC. Aim 3 proposes moderator (i.e., age, gender, surgical diversion type) and mediator (i.e., patient activation, distress) analyses of intervention efficacy. We hypothesize that RSBC will be significantly more successful among (a) older, (b) female participants, and (c) patients with a conduit diversion type. Elevated levels of patient activation (i.e., higher self-care knowledge, self-efficacy, lower distress) will mediate the intervention effects. Exploratory Aim 4 will examine the costs and potential savings associated with developing and implementing the RSBC intervention. We hypothesize that initial development and implementation costs of RSBC will be offset by reduced nurse/ER visits. The scientific premise is strong and supported by an established theoretical framework, extensive pilot data and a rigorous application of clinical research methods. The proposed study is highly innovative, as it comprehensively addresses unmet needs of both patients and caregivers from pre- and (immediate) post-treatment to recovery. This is achieved through an innovative combination of in-person preparation and skill-building and web-based technology. If successful, RSBC has the potential to significantly change clinical care for patients and caregivers with MIBC.

抽象的肌肉浸润性膀胱癌（MIBC）的治疗涉及去除膀胱和建造新的空白系统，对患者和护理人员来说在身体和心理方面具有挑战性。根据我们已发表的文献和广泛的试验数据，患者和看护者的未经含义广泛从诊断开始，卫生保健专业人员无法充分解决的治疗和恢复。我们建议通过对全面的，2部分的改进和评估来满足这些未满足的需求（面对面的和基于网络的）干预措施，针对患者和护理人员。具体而言，在目标1期间，形成性阶段，我们建议借助于已建立的患者/护理人员顾问委员会。干预措施，对膀胱癌（RSBC）的恢复支持，由训练有素的医疗保健专业人员组成（模块1）为患者和看护人提供适应即将进行的治疗和恢复的技能时期。接下来是处理后的，基于互动网络的程序（模块2），以进一步提供支持患者和护理人员提高生活质量（QOL）并减少感染和护士访问。 RSBC干预将在12个月的随机对照试验中进行评估（AIM 2）患者和护理人员二元组（n = 330个初始; 230最终样本），而注意力和注意力比较结合了关注健康的护理排放指令和模块的条件。基本的患者和护理人员的结果将得到改善，QoL被认为是显着的参与者中随机分为RSBC。次要结果将减少感染和护士 - 随机分为RSBC的患者的急诊就诊。 AIM 3提出主持人（即年龄，性别，手术转移类型）和调解人（即患者激活，困扰）干预功效的分析。我们假设这一点 RSBC在（a）年龄较大，（b）女性参与者和（c）患有A 导管转移类型。患者激活水平升高（即，自我保健知识，自我效能感，较低困扰）将调解干预效果。探索目标4将检查成本和潜在节省与开发和实施RSBC干预有关。我们假设最初的发展 RSBC的实施成本将被减少护士/急诊就诊所抵消。科学前提很强并由已建立的理论框架，广泛的试验数据和严格应用临床研究方法。拟议的研究具有很高的创新性，因为它全面解决了未定的患者和护理人员的需求从治疗前和（立即）治疗到康复。这是实现的通过面对面准备，技能建设和基于网络的技术的创新组合。如果成功的RSBC有可能对MIBC的患者和护理人员显着改变临床护理。