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| Name | Class |
|---|---|
| Fox Chase Cancer Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer Resource Information Support (CRIS) | Behavioral | Intervention support is patient initiated and accessed as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168 | Baseline |
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168 | 1 month |
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Exploratory Cost Analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Diefenbach, PhD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health | Manhasset | New York | 11030 | United States | ||
| Fox Chase Cancer Center |
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.
The study protocol, including the statistical analysis plan, informed consent form, data dictionary, and de-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
De-identified, pooled IPD will be made freely available on Open Science (https://osf.io/hy63z/). If additional information is requested, access can be provisioned by emailing the PI and completing a data use agreement.
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N = 174 participants (109 patient survivors, 65 caregivers) met study inclusion criteria and were enrolled in study. While this is not a dyad study, patients and caregivers who opted to participate were randomly assigned to the same conditions (i.e., intervention or enhanced usual care control arm). Our analyses comprised the following groups: (Intervention (Survivors), N = 47; Intervention (Caregivers), N = 31; Usual Care Enhanced (Survivors), N = 62, Usual Care Enhanced (Caregivers), N = 34.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (Survivors) | Bladder cancer survivors 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. |
| FG001 | Intervention (Caregivers) | Caregivers of bladder cancer survivors 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. |
| FG002 | Usual Care Enhanced (Survivors) | Bladder cancer survivors receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual. |
| FG003 | Usual Care Enhanced (Caregivers) | Caregivers of bladder cancer survivors receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention (Survivors) | Bladder cancer survivors 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | Baseline |
|
12-months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention (Survivors) | Bladder cancer survivors 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. |
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Limitations included the following: (1) The COVID-19 pandemic halted recruitment efforts for a considerable amount of time, reducing our overall number of patients. (2) Fewer caregivers (63%) were enrolled into the trial compared with patients; caregivers who agreed to participate may have somewhat differed from those who declined. ( 3) The inability to track software use objectively required reliance on self-report data, therefore hampering our QOL effect conclusions among caregivers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Diefenbach | Northwell Health | 516-600-1400 | mdiefenbach@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2025 | Dec 5, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2023 | Dec 5, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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Participants will be randomized based on a randomization table developed by study statistician. Care providers are not informed of the assigned study condition. Patients complete assessments through Redcap survey. Data analyst will be blinded to the nature of the numerical assignment of intervention vs control condition.
| Usual Care Enhanced | Behavioral | Usual care is enhanced with the addition of the NCI Facing Forward brochure |
|
| 3 months |
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168 | 6 months |
| Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy | Bladder cancer survivor quality of life was assessed using the 42-item FACT-BL-CYS, which employed a 5-point Likert-type scale ranging from 0-4. Scale was computed as per published instructions: Higher summary and subscale scores indicated better quality of life. Median imputation at the item level was performed if at least 2/3 of items per subscales had responses. Potential score range for each subscale: Physical well-being (7 items): 0-28; Social/family well-being (7 items): 0-28; Emotional well-being (6 items): 0-24; Functional well-being (7 items): 0-28; BL-CYS well-being (15 items): 0-60. Potential score range for total score: 0-168 | 12 months |
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12. | Baseline |
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12. | 1 month |
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12. | 3 months |
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12. | 6 months |
| Quality of Life Caregiver: The Caregiver Quality of Life Index-C | Caregiver quality of life was assessed using an abbreviated version of the 35-item CQOLC, (including items 1, 3, 5, 6, 7, 8, 11, 14, 19, 22, 28, and 34) and employing a 5-point Likert type scale ranging from 0-4; items were reverse scored so that a higher score indicated better quality of life. Items were summed together to get a total score, and median imputation was completed at the item level if at least 2/3 of items asked had responses (8+ items). Potential score range for total score: 0-48. Potential score range for each subscale: Disruptiveness (3 items; items 1, 3, 5): 0-12; Financial concerns (3 items; items 6, 7, 8): 0-12; Emotional distress (3 items; items 11, 14, 19): 0-12; Positive adaptation (3 items; items 22, 28, 34): 0-12. | 12 months |
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 12 months |
Costs relative to the development, implementation & maintenance of the intervention and cost of post-treatment care from the medical and billing records.
| 12 months |
| Philadelphia |
| Pennsylvania |
| 19111 |
| United States |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Survey incomplete since after data collection period |
|
| Intervention (Caregivers) |
Caregivers of bladder cancer survivors 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. |
| BG002 | Usual Care Enhanced (Survivors) | Bladder cancer survivors receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual. |
| BG003 | Usual Care Enhanced (Caregivers) | Caregivers of bladder cancer survivors receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual. |
| BG004 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Urinary Diversion Decision | Urinary Diversion Decision: Bladder cancer survivors and their associated caregivers were asked to report on their shared decision regarding the urinary diversion method. Depending on clinical factors and bladder cancer survivor and caregiver preferences, there are three possible urinary diversion methods : (a) ileal conduit, (b) Indiana pouch, and c) neobladder. | Count of Participants | Participants |
|
| OG001 | Usual Care Enhanced (Survivors) | Bladder cancer survivors receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual. |
|
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| Primary | 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 | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | 1 month |
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| Primary | 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 | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | 3 months |
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| Primary | 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 | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | 6 months |
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| Primary | 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 | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | 12 months |
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| Primary | 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. | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | Baseline |
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| Primary | 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. | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | 1 month |
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| Primary | 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. | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | 3 months |
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| Primary | 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. | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | 6 months |
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| Primary | 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. | ITT | Posted | Mean | Standard Deviation | Quality of Life Score | 12 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | 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. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | 1 month |
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| Secondary | 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. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | 12 months |
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| Other Pre-specified | 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. | We are unable to explore costs and potential savings associated with developing and implementing the RSBC intervention due to unscheduled nurse, ER visits or infection findings. | Posted | 6 months |
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| Other Pre-specified | 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. | We are unable to explore costs and potential savings associated with developing and implementing the RSBC intervention due to unscheduled nurse, ER visits or infection findings. | Posted | 12 months |
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| 4 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Intervention (Caregivers) | Caregivers of bladder cancer survivors 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Usual Care Enhanced (Survivors) | Bladder cancer survivors receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual. | 6 | 62 | 0 | 62 | 0 | 62 |
| EG003 | Usual Care Enhanced (Caregivers) | Caregivers of bladder cancer survivors receive standard instructions about post-op care from nursing staff plus the NCI published Facing forward cancer survivorship manual. | 0 | 34 | 0 | 34 | 0 | 34 |
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |