N/A
Completed N=174
Recovery Support for Bladder Cancer Patients and Caregivers
Bladder Cancer · Patient Engagement · Patient Empowerment · Ileal Conduit
Source: ClinicalTrials.gov NCT04055311 ↗
Enrolled (actual)
174
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy — 117.59; 118.70 Quality of Life Score — p=0.772
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy |
130.46; 123.21 | 0.18 |
| PRIMARY Quality of Life Caregiver: The Caregiver Quality of Life Index-C |
35.12; 36.88 | 0.073 |
| SECONDARY Infection Rate (Biological Factor) |
30; 37; 6; 11 | 0.48 |
| SECONDARY Visiting Nurse/ER Visits |
21; 24; 15; 25 | 0.393 |
Eligibility Criteria
Inclusion Criteria
- (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
Exclusion Criteria
- (a) the caregiving relationship is temporary (e.g., an out-of-town relative provides temporary support) as stated by both patient and caregiver.
Data sourced from ClinicalTrials.gov (NCT04055311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.