An interventional study of Cancer Resource Information Support (CRIS) and Usual Care Enhanced in Bladder Cancer, Patient Engagement and Patient Empowerment, sponsored by Northwell Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Northwell Health · Not applicable, Interventional, and Supportive care
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.
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 174 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
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Exclusion Criteria:
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
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
Usual care is enhanced with the addition of the NCI Facing Forward brochure
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 6 months
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.
Time frame: 12 months
Bladder cancer survivor patients and associated caregivers were recruited from Northwell Health and Fox Chase Cancer Center/Temple University Hospital between October 2018 to June 2024. The study team reviewed electronic medical records, screening physicians' schedules for eligible survivors and leveraged physician referrals for recruitment. Following identification of eligible patient survivors, their associated caregivers were also assessed for eligibility and approached for recruitment.
| Milestone | Intervention (Survivors) | Intervention (Caregivers) | Usual Care Enhanced (Survivors) | Usual Care Enhanced (Caregivers) |
|---|---|---|---|---|
| Started | 47 | 31 | 62 | 34 |
| 1-month | 39 | 24 | 53 | 30 |
| 3-month | 37 | 21 | 51 | 30 |
| 6-month | 36 | 21 | 49 | 31 |
| 12-month | 28 | 16 | 38 | 26 |
| Completed | 28 | 16 | 38 | 26 |
| Not completed | 19 | 15 | 24 | 8 |
| Withdrew: Death | 4 | 0 | 6 | 0 |
| Withdrew: Lost to follow-up | 8 | 9 | 10 | 5 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 4 | 5 | 4 | 2 |
| Withdrew: Survey incomplete since after data collection period | 3 | 1 | 3 | 1 |
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 Score | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | 117.59 ± 21.68 | 118.70 ± 25.46 |
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 Score | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | 116.34 ± 22.94 | 106.82 ± 22.74 |
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 Score | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | 127.50 ± 18.14 | 119.98 ± 23.03 |
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 Score | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | 129.71 ± 21.51 | 121.29 ± 25.48 |
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 Score | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | 130.46 ± 21.01 | 123.21 ± 24.73 |
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 Score | Intervention (Caregivers) | Usual Care Enhanced (Caregivers) |
|---|---|---|
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | 34.29 ± 8.75 | 33.21 ± 8.28 |
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 Score | Intervention (Caregivers) | Usual Care Enhanced (Caregivers) |
|---|---|---|
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | 32.07 ± 9.18 | 34.33 ± 6.08 |
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 Score | Intervention (Caregivers) | Usual Care Enhanced (Caregivers) |
|---|---|---|
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | 34.05 ± 6.79 | 35.90 ± 7.74 |
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 Score | Intervention (Caregivers) | Usual Care Enhanced (Caregivers) |
|---|---|---|
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | 35.90 ± 8.90 | 35.00 ± 8.92 |
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 Score | Intervention (Caregivers) | Usual Care Enhanced (Caregivers) |
|---|---|---|
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | 35.12 ± 8.52 | 36.88 ± 9.95 |
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.
| Participants | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| No Infection Present — No Infection Present | 33 | 43 |
| Infection Present — No Infection Present | 3 | 5 |
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.
| Participants | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| No Infection Present | 32 | 39 |
| Infection Present | 4 | 9 |
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.
| Participants | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| No Infection Present | 30 | 38 |
| Infection Present | 6 | 10 |
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.
| Participants | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| No Infection Present | 30 | 37 |
| Infection Present | 6 | 11 |
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.
| Participants | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| No ER or Nurse Visit | 29 | 41 |
| ER or Nurse Visit | 7 | 8 |
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.
| Participants | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| No ER or Nurse Visit | 25 | 32 |
| ER or Nurse Visit | 11 | 17 |
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.
| Participants | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| No ER or Nurse Visit | 21 | 29 |
| ER or Nurse Visit | 15 | 20 |
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.
| Participants | Intervention (Survivors) | Usual Care Enhanced (Survivors) |
|---|---|---|
| No ER or Nurse Visit | 21 | 24 |
| ER or Nurse Visit | 15 | 25 |
Costs relative to the development, implementation \& maintenance of the intervention and cost of post-treatment care from the medical and billing records.
No measurements were reported for this outcome.
Costs relative to the development, implementation \& maintenance of the intervention and cost of post-treatment care from the medical and billing records.
No measurements were reported for this outcome.
Collected over 12-months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention (Survivors) | 4/47 (8.5%) | 0/47 (0%) | 0/47 (0%) |
| Intervention (Caregivers) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Usual Care Enhanced (Survivors) | 6/62 (9.7%) | 0/62 (0%) | 0/62 (0%) |
| Usual Care Enhanced (Caregivers) | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Age, Continuous(Years) | Intervention (Survivors) | Intervention (Caregivers) | Usual Care Enhanced (Survivors) | Usual Care Enhanced (Caregivers) | Total |
|---|---|---|---|---|---|
| Mean | 66.69 ± 9.54 | 60.55 ± 12.38 | 67.10 ± 9.83 | 59.32 ± 12.60 | 64.27 ± 11.28 |
| Sex: Female, Male(Participants) | Intervention (Survivors) | Intervention (Caregivers) | Usual Care Enhanced (Survivors) | Usual Care Enhanced (Caregivers) | Total |
|---|---|---|---|---|---|
| Female | 11 | 26 | 20 | 31 | 88 |
| Male | 36 | 5 | 42 | 3 | 86 |
| Race (NIH/OMB)(Participants) | Intervention (Survivors) | Intervention (Caregivers) | Usual Care Enhanced (Survivors) | Usual Care Enhanced (Caregivers) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 7 | 1 | 10 |
| White | 42 | 27 | 54 | 29 | 152 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 4 | 1 | 2 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Intervention (Survivors) | Intervention (Caregivers) | Usual Care Enhanced (Survivors) | Usual Care Enhanced (Caregivers) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 0 | 2 | 8 |
| Not Hispanic or Latino | 43 | 28 | 61 | 32 | 164 |
| Unknown or Not Reported | 1 | 0 | 1 | 0 | 2 |
| Region of Enrollment(Participants) | Intervention (Survivors) | Intervention (Caregivers) | Usual Care Enhanced (Survivors) | Usual Care Enhanced (Caregivers) | Total |
|---|---|---|---|---|---|
| United States | 47 | 31 | 62 | 34 | 174 |
| Urinary Diversion Decision(Participants) | Intervention (Survivors) | Intervention (Caregivers) | Usual Care Enhanced (Survivors) | Usual Care Enhanced (Caregivers) | Total |
|---|---|---|---|---|---|
| Ileal conduit | 31 | 22 | 40 | 21 | 114 |
| Indiana pouch | 1 | 2 | 4 | 2 | 9 |
| Neobladder | 12 | 6 | 17 | 11 | 46 |
| Other | 3 | 1 | 1 | 0 | 5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
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