Recovery Support for Bladder Cancer Patients and Caregivers

NCT04055311 | Completed Results

• 1 other identifier: 18-0400
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer; Patient Engagement; Patient Empowerment; Ileal Conduit

Keywords

patient focused intervention; caregiver; Internet based information; recovery support; bladder cancer; urinary diversion; neobladder

Outcome Measures

Primary Outcomes (10)

• Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

  Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

  Baseline

• Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

  Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

  1 month

• Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

  Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

  3 months

• Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

  Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

  6 months

• Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy

  Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168

  12 months

• Quality of Life Caregiver: The Caregiver Quality of Life Index-C

  Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

  Baseline

• Quality of Life Caregiver: The Caregiver Quality of Life Index-C

  Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

  1 month

• Quality of Life Caregiver: The Caregiver Quality of Life Index-C

  Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

  3 months

• Quality of Life Caregiver: The Caregiver Quality of Life Index-C

  Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

  6 months

• Quality of Life Caregiver: The Caregiver Quality of Life Index-C

  Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12.

  12 months

Secondary Outcomes (8)

• Infection Rate (Biological Factor)

  1 month

• Infection Rate (Biological Factor)

  3 months

• Infection Rate (Biological Factor)

  6 months

• Infection Rate (Biological Factor)

  12 months

• Visiting Nurse/ER Visits

  1 month

Other Outcomes (2)

• Exploratory Cost Analysis

  6 months

• Exploratory Cost Analysis

  12 months

Study Arms (2)

Usual care enhanced

ACTIVE COMPARATOR

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

Intervention

EXPERIMENTAL

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)

Interventions

Cancer Resource Information Support (CRIS) BEHAVIORAL

Intervention support is patient initiated and accessed as needed

Intervention

Usual Care Enhanced BEHAVIORAL

Usual care is enhanced with the addition of the NCI Facing Forward brochure

Usual care enhanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead
• Fox Chase Cancer Center: collaborator

Study Sites (2)

Northwell Health

Manhasset, New York, 11030, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Limitations included the following: (1) The COVID-19 pandemic halted recruitment efforts for a considerable amount of time, reducing our overall number of patients. (2) Fewer caregivers (63%) were enrolled into the trial compared with patients; caregivers who agreed to participate may have somewhat differed from those who declined. ( 3) The inability to track software use objectively required reliance on self-report data, therefore hampering our QOL effect conclusions among caregivers.

Results Point of Contact

• Title: Michael Diefenbach
• Organization: Northwell Health

mdiefenbach@northwell.edu

516-600-1400

Study Officials

• Michael Diefenbach, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized based on a randomization table developed by study statistician. Care providers are not informed of the assigned study condition. Patients complete assessments through Redcap survey. Data analyst will be blinded to the nature of the numerical assignment of intervention vs control condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Behavioral Research

Model Details: The RSBC intervention will be evaluated in a 12-month randomized controlled trial among patients and caregiver dyads (anticipated to recruit a total of 287 participants) against a time and attention comparison condition that focuses on general wellness.

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 13, 2019
• Study Start: October 1, 2018
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: March 19, 2026
• Results First Posted: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol, including the statistical analysis plan, informed consent form, data dictionary, and de-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
• Access Criteria: De-identified, pooled IPD will be made freely available on Open Science (https://osf.io/hy63z/). If additional information is requested, access can be provisioned by emailing the PI and completing a data use agreement.

Locations

US (2)