Recovery Support for Bladder Cancer Patients and Caregivers

Bladder Cancer Clinical Trial

Official title:

Recovery Support for Bladder Cancer Patients and Caregivers: A Multimodal Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055311
• Other study ID #: 18-0400
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Northwell Health
• Contact: Michael Diefenbach, PhD
• Phone: 516-600-1440
• Email: mdiefenbach[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Ileal Conduit
• Patient Empowerment
• Patient Engagement
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Cancer Resource Information Support (CRIS)
Intervention support is patient initiated and accessed as needed
• Usual Care Enhanced
Usual care is enhanced with the addition of the NCI Facing Forward brochure

Locations

Country	Name	City	State
United States	Northwell Health	Manhasset	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Cost Analysis	Costs relative to the development, implementation & maintenance of the intervention and cost of post-treatment care from the medical and billing records.	6 months
Other	Exploratory Cost Analysis	Costs relative to the development, implementation & maintenance of the intervention and cost of post-treatment care from the medical and billing records.	12 months
Primary	Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	Baseline,
Primary	Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	1 month
Primary	Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	3 months
Primary	Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	6 months
Primary	Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy	12 months
Primary	Quality of Life Caregiver: The Caregiver Quality of Life Index-C	The Caregiver Quality of Life Index-C	Baseline
Primary	Quality of Life Caregiver: The Caregiver Quality of Life Index-C	The Caregiver Quality of Life Index-C	1 month
Primary	Quality of Life Caregiver: The Caregiver Quality of Life Index-C	The Caregiver Quality of Life Index-C	3 months,
Primary	Quality of Life Caregiver: The Caregiver Quality of Life Index-C	The Caregiver Quality of Life Index-C	6 months,
Primary	Quality of Life Caregiver: The Caregiver Quality of Life Index-C	The Caregiver Quality of Life Index-C	12 months,
Secondary	Infection rate (biological factor)	Infection rate will be assessed through self-report and verified through electronic medical chart review for each patient	1 month
Secondary	Infection rate (biological factor)	Infection rate will be assessed through self-report and verified through electronic medical chart review for each patient	3 months
Secondary	Infection rate (biological factor)	Infection rate will be assessed through self-report and verified through electronic medical chart review for each patient	6 months
Secondary	Infection rate (biological factor)	Infection rate will be assessed through self-report and verified through electronic medical chart review for each patient	12 months
Secondary	Visiting Nurse/ER visits	Nurse or ER visits will be assessed through self-report and verified through electronic medical chart review	1 month
Secondary	Visiting Nurse/ER visits	Nurse or ER visits will be assessed through self-report and verified through electronic medical chart review	3 months
Secondary	Visiting Nurse/ER visits	Nurse or ER visits will be assessed through self-report and verified through electronic medical chart review	6 months
Secondary	Visiting Nurse/ER visits	Nurse or ER visits will be assessed through self-report and verified through electronic medical chart review	12 months