||5R01CA224918-02 Interpret this number
||Feinstein Institute For Medical Research
||Recovery Support for Bladder CA Patients and Caregivers: a Multimodal Approach
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.
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