Skip to main content
OpenTrials
Completed

NCT Number: NCT04055311

Recovery Support for Bladder Cancer Patients and Caregivers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Cancer Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Ileal Conduit Male Urogenital Diseases Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Empowerment Patient Engagement Patient Participation Treatment Adherence and Compliance Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwell Health, Manhasset, New York, United States

Loading trial locations.

About this study

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 (anticipated to recruit a total of 287 participants) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Cancer Resource Information Support (CRIS)

Behavioral

Intervention support is patient initiated and accessed as needed

Usual Care Enhanced

Behavioral

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

Primary outcomes

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

    Time frame: Baseline

    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

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

    Time frame: 1 month

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

    Time frame: 3 months

    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

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

    Time frame: 6 months

    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

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

    Time frame: 12 months

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

    Time frame: Baseline

    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.

  7. Quality of Life Caregiver: The Caregiver Quality of Life Index-C

    Time frame: 1 month

    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.

  8. Quality of Life Caregiver: The Caregiver Quality of Life Index-C

    Time frame: 3 months

    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.

  9. Quality of Life Caregiver: The Caregiver Quality of Life Index-C

    Time frame: 6 months

    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.

  10. Quality of Life Caregiver: The Caregiver Quality of Life Index-C

    Time frame: 12 months

    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.

Secondary outcomes

  1. Infection Rate (Biological Factor)

    Time frame: 1 month

    Infection rate was assessed through self-report and verified through electronic medical chart review for each patient. Only patients with complete data on infection status (i.e., noted as having an "infection present" or "no infection present") were included in our analysis.

  2. Infection Rate (Biological Factor)

    Time frame: 3 months

    Infection rate was assessed through self-report and verified through electronic medical chart review for each patient. Only patients with complete data on infection status (i.e., noted as having an "infection present" or "no infection present") were included in our analysis.

  3. Infection Rate (Biological Factor)

    Time frame: 6 months

    Infection rate was assessed through self-report and verified through electronic medical chart review for each patient. Only patients with complete data on infection status (i.e., noted as having an "infection present" or "no infection present") were included in our analysis.

  4. Infection Rate (Biological Factor)

    Time frame: 12 months

    Infection rate was assessed through self-report and verified through electronic medical chart review for each patient. Only patients with complete data on infection status (i.e., noted as having an "infection present" or "no infection present") were included in our analysis.

  5. Visiting Nurse/ER Visits

    Time frame: 1 month

    Nurse or ER visits were assessed through self-report and verified through electronic medical record chart review for each patient. Only patients with complete data on ER/nurse visits (i.e., noted as having "ER or nurse visit" or "No ER or nurse visit" were included in our analysis.

  6. Visiting Nurse/ER Visits

    Time frame: 3 months

    Nurse or ER visits were assessed through self-report and verified through electronic medical record chart review for each patient. Only patients with complete data on ER/nurse visits (i.e., noted as having "ER or nurse visit" or "No ER or nurse visit" were included in our analysis.

  7. Visiting Nurse/ER Visits

    Time frame: 6 months

    Nurse or ER visits were assessed through self-report and verified through electronic medical record chart review for each patient. Only patients with complete data on ER/nurse visits (i.e., noted as having "ER or nurse visit" or "No ER or nurse visit" were included in our analysis.

  8. Visiting Nurse/ER Visits

    Time frame: 12 months

    Nurse or ER visits were assessed through self-report and verified through electronic medical record chart review for each patient. Only patients with complete data on ER/nurse visits (i.e., noted as having "ER or nurse visit" or "No ER or nurse visit" were included in our analysis.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Fox Chase Cancer Center

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2019
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.