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

摘要 肌肉浸润性膀胱癌(MIBC)的治疗包括切除膀胱和构建 新的排尿系统，对患者和照顾者来说，在生理和心理上都是巨大的挑战。 根据我们发表的文献和广泛的试点数据，患者和照顾者有大量的未得到满足 从诊断之时起的信息、社会、心理、工具和医疗需求，通过 医疗保健专业人员没有充分解决的治疗和康复问题。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，面向患者和照顾者。具体来说，在目标1期间，形成者 阶段，我们建议进一步完善我们新开发的干预组件， 成立了患者/护理者顾问委员会。干预，膀胱癌康复支持(RSBC)， 包括与训练有素的医疗保健专业人员面对面的治疗前准备指导会议 (模块1)让患者和照顾者掌握适应即将到来的治疗和康复的技能 句号。之后是一个基于网络的后处理交互式方案(模块2)，以提供进一步的 为患者和护理人员提供支持，以提高生活质量(QOL)，减少感染和护士/急诊室 来访。RSBC干预将在一项为期12个月的随机对照试验(AIM 2)中进行评估 患者和照顾者二人组(N=330初始样本；230最终样本)与时间和注意力的比较 包含护理出院标准说明和侧重于健康的模块的情况。主要 患者和照顾者的结果都将改善生活质量，这被认为是显著的 在随机加入RSBC的参与者中更高。次要结果将是减少感染和护理- 随机纳入RSBC的患者的急诊室就诊。目标3建议调节因素(即年龄、性别、手术分流 类型)和中介(即患者的激活度、苦恼)对干预效果的分析。我们假设 在(A)老年、(B)女性参与者和(C)患有 导管导流型。患者活跃度提高(即更高的自我护理知识、自我效能、更低的 危难)将调解干预效果。探索性目标4将检查成本和潜在的节省 与制定和实施RSBC干预措施有关。我们假设最初的发展 RSBC的实施成本将被护士/急诊室就诊的减少所抵消。科学的前提是强有力的 并得到了既定的理论框架、广泛的试点数据和严格的 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满足的问题 从治疗前和(立即)治疗后到康复，患者和照顾者的需求。这是实现的 通过身临其境的准备和技能建设与基于网络的技术的创新结合。如果 成功的RSBC有可能显著改变对MIBC患者和照顾者的临床护理。

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.