Recovery Support for Bladder Cancer Patients and Caregivers

Status: complete

For patients with certain types of bladder cancer, the removal of the bladder and the construction of an artificial bladder or reservoir are the only treatment options. Both before and after treatment, patients and caregivers face profound challenges preparing for surgery and planning for tasks during their recovery. To aid in recovery and enhance quality of life this program of research will develop and evaluate a multi-stage intervention geared towards patients and their caregivers. Part 1 of this program will have a nurse or trained health professional prepare both patients and their caregivers before treatment about the upcoming surgery. During this time the nurse will also demonstrate the necessary tools and techniques for stoma care. In addition, patients and their caregivers will receive access to a recovery website, specifically designed for bladder cancer patients to be used as a resource for after treatment. The website will be part 2 of this research and will contain important recovery information, videos about post-surgical care, testimonials by other patients and physicians and a variety of other resources. Patients and caregivers in the control group will receive the Facing Forward brochures from the National Cancer Institute in part 2. This research has been funded by the National Cancer Institute and will be the first study to address the needs of bladder cancer patients and their caregivers. The ultimate goal of the study is to reduce infections and unplanned nurse/ER visits and improve quality of life for both patients and their caregivers. This new program will be evaluated over the course of 12-months and if found successful, has the potential to be disseminated throughout the health care systems of the two study sites.

Inclusion Criteria

(a) male or female patients diagnosed with BC
(b) undergoing bladder removal surgery and one of the following urinary diversions: 1) ileal conduit, 2) neobladder or 3) Indiana pouch.
(c) did not need or completed neo-adjuvant chemotherapy,
(d) able to communicate with ease in English

Exclusion Criteria

(a) the caregiving relationship is temporary (e.g., an out-of-town relative provides temporary support) as stated by both patient and caregiver.

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.

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Recovery Support for Bladder Cancer Patients and Caregivers

Description

Eligibility Criteria

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Trial Objectives and Outline

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