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

摘要 肌层浸润性膀胱癌（MIBC）的治疗包括切除膀胱并构建一个 新的排泄系统，对患者和护理人员的身体和心理都具有深刻的挑战性。 根据我们已发表的文献和广泛的试点数据，患者和护理人员有广泛的未满足 信息，社会，心理，工具和医疗需求，从诊断的时间，通过 医疗保健专业人员没有充分处理的治疗和康复问题。我们建议 通过完善和评估由两部分组成的综合性（面对面和 基于网络的）干预，面向患者和护理者。具体而言，在目标1中， 我们建议在第三阶段，借助 建立病人/护理人员咨询委员会。膀胱癌康复支持（RSBC） 由经过培训的医疗保健专业人员进行的治疗前现场准备指导会议组成 （模块1）使患者和护理人员具备适应即将到来的治疗和康复的技能 期随后是一个治疗后，互动式基于网络的程序（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）并减少感染和护理/ER 探访RSBC干预将在一项为期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（N=330初始样本; 230最终样本）与时间和注意力比较 条件，包括护理标准出院指示和侧重于健康的模块。初级 患者和护理人员的结局将改善QOL，假设QOL显著 在随机分配到RSBC的参与者中，次要结果将是减少感染和护理- 随机分配至RSBC的患者的ER访视。目标3提议主持人（即，年龄、性别、手术分流 类型）和中介体（即，患者激活、痛苦）的干预效果分析。我们假设 RSBC在（a）老年受试者，（B）女性受试者，和（c） 管道导流型患者激活水平升高（即，自我保健知识、自我效能感较高， （2）干预效果的中介作用。探索性目标4将研究成本和潜在的节约 与制定和实施RSBC干预措施有关。我们假设最初的发展 RSBC的实施费用将通过减少护士/急诊室访问来抵消。科学前提是强有力的 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得到满足的问题， 患者和护理人员从治疗前和（立即）治疗后到康复的需求。实现这一点 通过创新性地将亲自准备、技能培养和基于网络的技术相结合。如果 RSBC的成功有可能显着改变MIBC患者和护理人员的临床护理。

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.