Recovery Support for Bladder Cancer Patients and Caregivers
Part of paid clinical trials in Manhasset, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT04055311
- Status
- Completed
Conditions
- Bladder Cancer
- Ileal Conduit
- Patient Empowerment
- Patient Engagement
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cancer Resource Information Support (CRIS) — BEHAVIORALIntervention support is patient initiated and accessed as needed
- Usual Care Enhanced — BEHAVIORALUsual care is enhanced with the addition of the NCI Facing Forward brochure
Study Details
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.
Key Dates
- Start date
- Oct 1, 2018
- Status verified
- Feb 2026
- Primary completion
- Dec 16, 2024
- Completion
- Dec 16, 2024
Study Design
- Enrollment
- 174 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: 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.
- Experimental: InterventionBladder 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.
Primary Outcome Measure
Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy [ Time Frame: Baseline ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwell Health | Manhasset | New York | 11030 | - |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | - |
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