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

• 批准号: 10216197
• 负责人: Michael A Diefenbach
• 金额: $ 61.23万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 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/10216197
• 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; 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

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 肌层浸润性膀胱癌 (MIBC) 的治疗包括切除膀胱和构建膀胱 新的排尿系统，对患者和护理人员来说在身体和心理上都面临着巨大的挑战。 根据我们发表的文献和广泛的试点数据，患者和护理人员还有大量未得到满足的问题 从诊断之时起，到信息、社会、心理、工具和医疗需求 医疗保健专业人员没有充分解决治疗和康复问题。我们建议 通过完善和评估全面的两部分（面对面和 基于网络的）干预，针对患者和护理人员。具体来说，在目标 1 期间，形成性 阶段，我们建议在 设立患者/护理人员咨询委员会。膀胱癌康复支持 (RSBC) 干预措施， 包括由训练有素的医疗保健专业人员进行的治疗前、现场准备指导课程 （模块 1）为患者和护理人员提供适应即将到来的治疗和康复的技能 时期。接下来是后处理、基于交互式网络的程序（模块 2），以提供进一步的帮助 为患者和护理人员提供支持，以提高生活质量 (QOL) 并减少感染和护士/急诊室 访问。 RSBC 干预措施将在一项为期 12 个月的随机对照试验（目标 2）中进行评估 患者和护理人员二人组（初始样本 N=330；最终样本 230）与时间和注意力进行比较 包含标准护理出院说明和以健康为重点的模块的条件。基本的 患者和护理人员的结果都将得到改善，假设生活质量将显着提高 随机分配到 RSBC 的参与者中更高。次要结果将是减少感染和护理 随机进入 RSBC 的患者进行急诊室就诊。目标 3 提出调节因素（即年龄、性别、手术分流 类型）和中介（即患者激活、痛苦）干预效果分析。我们假设 RSBC 在 (a) 年长者、(b) 女性参与者和 (c) 患有某种疾病的患者中会取得更大的成功 导管导流类型。患者积极性水平提高（即更高的自我护理知识、自我效能感、更低的自我保健能力） 痛苦）将调节干预效果。探索性目标 4 将检查成本和潜在的节省 与制定和实施 RSBC 干预措施相关。我们假设最初的发展 RSBC 的实施成本将通过减少护士/急诊室就诊次数来抵消。科学前提是强有力的 并得到既定的理论框架、广泛的试点数据和严格应用的支持 临床研究方法。拟议的研究具有高度创新性，因为它全面解决了未满足的问题 患者和护理人员从治疗前和（立即）治疗后到康复的需求。这样就实现了 通过现场准备和技能培养以及基于网络的技术的创新结合。如果 如果成功，RSBC 有可能显着改变 MIBC 患者和护理人员的临床护理。