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NCT04055311 · ClinicalTrials.gov registry record · NA
Recovery Support for Bladder Cancer Patients and Caregivers
A NA study, sponsored by Northwell Health.
- Completed
- Registry status
- NA
- Development phase
- 174
- Enrollment target
NCT04055311: Completed NA study, sponsored by Northwell Health.
NCT04055311 is a NA study that has completed, run by Northwell Health. The registered enrollment target is 174 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04055311, a NA study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 174 participants
- Enrollment target
Study Summary
For patients with certain types of bladder cancer, the removal of the bladder and the construction of an artificial bladder or reservoir are the only treatment options. Both before and after treatment, patients and caregivers face profound challenges preparing for surgery and planning for tasks during their recovery. To aid in recovery and enhance quality of life this program of research will develop and evaluate a multi-stage intervention geared towards patients and their caregivers. Part 1 of this program will have a nurse or trained health professional prepare both patients and their caregivers before treatment about the upcoming surgery. During this time the nurse will also demonstrate the necessary tools and techniques for stoma care. In addition, patients and their caregivers will receive access to a recovery website, specifically designed for bladder cancer patients to be used as a resource for after treatment. The website will be part 2 of this research and will contain important recovery information, videos about post-surgical care, testimonials by other patients and physicians and a variety of other resources. Patients and caregivers in the control group will receive the Facing Forward brochures from the National Cancer Institute in part 2. This research has been funded by the National Cancer Institute and will be the first study to address the needs of bladder cancer patients and their caregivers. The ultimate goal of the study is to reduce infections and unplanned nurse/ER visits and improve quality of life for both patients and their caregivers. This new program will be evaluated over the course of 12-months and if found successful, has the potential to be disseminated throughout the health care systems of the two study sites.
Primary Outcome
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 w
Interventions
- BEHAVIORAL Cancer Resource Information Support (CRIS)
- BEHAVIORAL Usual Care Enhanced
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2024-12-16 |
| Phase | NA |
What the finished NCT04055311 record still lists
NCT04055311 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Cancer Resource Information Support (CRIS) is the first listed.
NCT04055311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04055311 about?
NCT04055311 is a clinical study titled "Recovery Support for Bladder Cancer Patients and Caregivers". For patients with certain types of bladder cancer, the removal of the bladder and the construction of an artificial bladder or reservoir are the only treatment options. Both before and after treatment, patients and caregivers face profound challenges preparing for surgery and planning for tasks duri...
What is the current status of trial NCT04055311?
This trial is currently completed. It is a NA study. The enrollment target is 174 participants. The study started on 2018-10-01. Estimated completion is 2024-12-16.
What interventions are being tested in trial NCT04055311?
The interventions under investigation include: Cancer Resource Information Support (CRIS) (BEHAVIORAL), Usual Care Enhanced (BEHAVIORAL).
Who is sponsoring clinical trial NCT04055311?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04055311's enrollment target sits among peer trials
174 610th of 2000 higher than 1,390 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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