Recovery Support for Bladder Cancer Patients and Caregivers

May 10, 2023 updated by: Michael Diefenbach, Northwell Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
        • Principal Investigator:
          • Michael Diefenbach, PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Contact:
        • Principal Investigator:
          • Suzanne Miller, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care enhanced
Bladder cancer patients & caregivers receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual.
Behavioral: Usual Care Enhanced
Usual care is enhanced with the addition of the NCI Facing Forward brochure
Experimental: Intervention
Bladder cancer patients & caregivers receive standard instructions about post-op care from nursing staff plus access to Internet based software program, specifically designed for this research study. Software program contains relevant bladder cancer care instructions through videos, text, and graphics.
Behavioral: Cancer Resource Information Support (CRIS)
Intervention support is patient initiated and accessed as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
Time Frame: Baseline,
The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
Baseline,
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
Time Frame: 1 month
The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
1 month
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
Time Frame: 3 months
The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
3 months
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
Time Frame: 6 months
The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
6 months
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
Time Frame: 12 months
The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy
12 months
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
Time Frame: Baseline
The Caregiver Quality of Life Index-C
Baseline
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
Time Frame: 1 month
The Caregiver Quality of Life Index-C
1 month
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
Time Frame: 3 months,
The Caregiver Quality of Life Index-C
3 months,
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
Time Frame: 6 months,
The Caregiver Quality of Life Index-C
6 months,
Quality of Life Caregiver: The Caregiver Quality of Life Index-C
Time Frame: 12 months,
The Caregiver Quality of Life Index-C
12 months,

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection rate (biological factor)
Time Frame: 1 month
Infection rate will be assessed through self-report and verified through electronic medical chart review for each patient
1 month
Infection rate (biological factor)
Time Frame: 3 months
Infection rate will be assessed through self-report and verified through electronic medical chart review for each patient
3 months
Infection rate (biological factor)
Time Frame: 6 months
Infection rate will be assessed through self-report and verified through electronic medical chart review for each patient
6 months
Infection rate (biological factor)
Time Frame: 12 months
Infection rate will be assessed through self-report and verified through electronic medical chart review for each patient
12 months
Visiting Nurse/ER visits
Time Frame: 1 month
Nurse or ER visits will be assessed through self-report and verified through electronic medical chart review
1 month
Visiting Nurse/ER visits
Time Frame: 3 months
Nurse or ER visits will be assessed through self-report and verified through electronic medical chart review
3 months
Visiting Nurse/ER visits
Time Frame: 6 months
Nurse or ER visits will be assessed through self-report and verified through electronic medical chart review
6 months
Visiting Nurse/ER visits
Time Frame: 12 months
Nurse or ER visits will be assessed through self-report and verified through electronic medical chart review
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Cost Analysis
Time Frame: 6 months
Costs relative to the development, implementation & maintenance of the intervention and cost of post-treatment care from the medical and billing records.
6 months
Exploratory Cost Analysis
Time Frame: 12 months
Costs relative to the development, implementation & maintenance of the intervention and cost of post-treatment care from the medical and billing records.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Collaborators

Fox Chase Cancer Center

Investigators

  • Principal Investigator: Michael Diefenbach, PhD, Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-0400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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