Clinical trial NCT04055311: Recovery Support for Bladder Cancer Patients and Caregivers
Official title: Recovery Support for Bladder Cancer Patients and Caregivers: A Multimodal Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Patient Engagement
Patient Empowerment
Ileal Conduit
Keywords: patient focused intervention
caregiver
Internet based information
recovery support
bladder cancer
urinary diversion
neobladder
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Fox Chase Cancer Center
First posted: 2019-08-13
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The RSBC intervention will be evaluated in a 12-month randomized controlled trial among patients and caregiver dyads (N=287 initial; 238 final sample) against a time and attention comparison condition that focuses on general wellness.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
timeFrame: Baseline,
measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
timeFrame: 1 month
measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
timeFrame: 3 months
measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
timeFrame: 6 months
measure: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
timeFrame: 12 months
measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C
timeFrame: Baseline
measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C
timeFrame: 1 month
measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C
timeFrame: 3 months,
measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C
timeFrame: 6 months,
measure: Quality of Life Caregiver: The Caregiver Quality of Life Index-C
timeFrame: 12 months,
Secondary outcomes:
measure: Infection rate (biological factor)
timeFrame: 1 month
measure: Infection rate (biological factor)
timeFrame: 3 months
measure: Infection rate (biological factor)
timeFrame: 6 months
measure: Infection rate (biological factor)
timeFrame: 12 months
measure: Visiting Nurse/ER visits
timeFrame: 1 month
measure: Visiting Nurse/ER visits
timeFrame: 3 months
measure: Visiting Nurse/ER visits
timeFrame: 6 months
measure: Visiting Nurse/ER visits
timeFrame: 12 months
Other outcomes:
measure: Exploratory Cost Analysis
timeFrame: 6 months
measure: Exploratory Cost Analysis
timeFrame: 12 months
Locations:
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Northwell Health
name: Michael Diefenbach, PhD
role: PRINCIPAL_INVESTIGATOR
References: