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
(anticipated to recruit a total of 287 participants) 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.
