Bladder CancerNCT04055311
Recovery Support for Bladder Cancer Patients and Caregivers
A study testing Cancer Resource Information Support (CRIS) in people with Bladder Cancer and Patient Engagement, run by Northwell Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Patient Engagement, Patient Empowerment
- What is being tested?
- Cancer Resource Information Support (CRIS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2018to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (a) the caregiving relationship is temporary (e.g., an out-of-town relative provides temporary support) as stated by both patient and caregiver.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwell Health
Manhasset, New York, 11030
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: 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.
Read the 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 (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.
- Conditions
- Bladder Cancer, Patient Engagement, Patient Empowerment, Ileal Conduit
- Being tested
- Cancer Resource Information Support (CRIS), Usual Care Enhanced
- Keywords
- patient focused intervention, caregiver, Internet based information, recovery support, bladder cancer, urinary diversion, neobladder
- Medical subject headings
- Urinary Bladder Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Resource Information Support (CRIS)Behavioural
Intervention support is patient initiated and accessed as needed
Usual Care EnhancedBehavioural
Usual care is enhanced with the addition of the NCI Facing Forward brochure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cancer Resource Information Support (CRIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (8)
Infection Rate (Biological Factor)
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.
Measured: 1 month
Infection Rate (Biological Factor)
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.
Measured: 3 months
Infection Rate (Biological Factor)
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.
Measured: 6 months
Infection Rate (Biological Factor)
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.
Measured: 12 months
Visiting Nurse/ER Visits
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.
Measured: 1 month
Visiting Nurse/ER Visits
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.
Measured: 3 months
Visiting Nurse/ER Visits
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.
Measured: 6 months
Visiting Nurse/ER Visits
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Oct 2018
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Fox Chase Cancer Center
- Responsible party
- Principal investigator, Michael Diefenbach, Northwell Health
- Investigators
- Michael Diefenbach, PhD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055311
- Sponsor's protocol ID
- 18-0400
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2019
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary and statistical analysis plan for those who wish to replicate our findings or make new discoveries, using our collected data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Support for Bladder Cancer Patients and Caregivers: A Multimodal Approach
- ClinicalTrials.gov ID
- NCT04055311
- Acronym / sponsor ID
- 18-0400
- Conditions
- Bladder Cancer, Patient Engagement, Patient Empowerment, Ileal Conduit
- Keywords
- patient focused intervention, caregiver, Internet based information, recovery support, bladder cancer, urinary diversion, neobladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Fox Chase Cancer Center
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Posted 19 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual care enhanced | Active comparator | Behavioral: Usual Care EnhancedBladder cancer patients \& caregivers receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual. |
| Intervention | Experimental | Behavioral: Cancer Resource Information Support (CRIS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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
Key exclusion criteria (1 listed)
- (a) the caregiving relationship is temporary (e.g., an out-of-town relative provides temporary support) as stated by both patient and caregiver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer Resource Information Support (CRIS)Intervention support is patient initiated and accessed as needed | Behavioural | Intervention |
| Usual Care EnhancedUsual care is enhanced with the addition of the NCI Facing Forward brochure | Behavioural | Usual care enhanced |
Primary outcome
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
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
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
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
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
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.
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.
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.
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.
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.
8 secondary outcomes
Infection Rate (Biological Factor)
Time frame: 1 month
Infection Rate (Biological Factor)
Time frame: 3 months
Infection Rate (Biological Factor)
Time frame: 6 months
Infection Rate (Biological Factor)
Time frame: 12 months
Visiting Nurse/ER Visits
Time frame: 1 month
Visiting Nurse/ER Visits
Time frame: 3 months
Visiting Nurse/ER Visits
Time frame: 6 months
Visiting Nurse/ER Visits
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary and statistical analysis plan for those who wish to replicate our findings or make new discoveries, using our collected data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Diefenbach, PhD principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Resource Information Support (CRIS) in people with Bladder Cancer and Patient Engagement, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.