Treatment for certain types of bladder cancer (BC) 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 investigators' 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.
Investigators 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, investigators
propose to further refine the 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=287
initial; 238 final sample) against a time and attention comparison condition (the Facing
Forward brochures). 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. Investigators 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. Investigators 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 BC.