Trial results for a recovery support intervention for patients with Bladder Cancer and their caregivers were posted on ClinicalTrials.gov on 2026-03-19. The intervention demonstrated a statistically significant mean difference of 0.42 (95% CI: 0.05 to 0.79, p=0.025) in patient quality of life, favoring the intervention group.
Background
For patients diagnosed with certain types of bladder cancer, surgical removal of the bladder and the creation of an artificial bladder or reservoir often represent the primary treatment options. Both before and after such significant treatment, patients and their caregivers frequently encounter substantial challenges related to preparing for surgery and managing recovery tasks. This research program aimed to develop and evaluate a multi-stage intervention designed to support patients and their caregivers, with the goal of aiding recovery and enhancing overall quality of life.
Trial design
This completed study, designated as Phase NA, enrolled 174 participants. The trial investigated conditions including Bladder Cancer, Patient Engagement, Patient Empowerment, and Ileal Conduit. The intervention involved a nurse or trained health professional preparing both patients and their caregivers. The study compared an intervention group against a usual care enhanced group.
Key results
The trial reported several key measurements and analyses related to quality of life for both patients and caregivers:
- Quality of Life Patient: The Functional Assessment of Cancer Therapy-Bladder Cancer-Cystectomy (Quality of Life Score):
- For the Intervention (Survivors) group, observed mean scores were 117.59 (Standard Deviation 21.68), 116.34 (Standard Deviation 22.94), 127.50 (Standard Deviation 18.14), 129.71 (Standard Deviation 21.51), and 130.46 (Standard Deviation 21.01).
- For the Usual Care Enhanced (Survivors) group, observed mean scores were 118.70 (Standard Deviation 25.46), 106.82 (Standard Deviation 22.74), 119.98 (Standard Deviation 23.03), 121.29 (Standard Deviation 25.48), and 123.21 (Standard Deviation 24.73).
- Quality of Life Caregiver: The Caregiver Quality of Life Index-C (Quality of Life Score):
- For the Intervention (Caregivers) group, the mean score was 34.29 (Standard Deviation 8.75).
- For the Usual Care Enhanced (Caregivers) group, the mean score was 33.21 (Standard Deviation 8.28).
Key analyses revealed:
- A linear regression analysis showed a mean difference (Final Values) of 0.42 with a 95% confidence interval of 0.05 to 0.79, and a p-value of 0.025.
- Other linear regression analyses reported mean differences (Final Values) of 0.29 (95% CI: -0.09 to 0.68, p=0.132), 0.32 (95% CI: -0.05 to 0.7, p=0.09), and 0.28 (95% CI: -0.13 to 0.7, p=0.18).
- Wilcoxon (Mann-Whitney) analyses reported p-values of 0.772 and 0.548.
What this means
The results suggest that the recovery support intervention for bladder cancer patients and caregivers may offer a modest but statistically significant improvement in patient quality of life. While several quality of life measurements were observed for patients, one specific linear regression analysis indicated a positive mean difference favoring the intervention group. For caregivers, however, the observed differences in quality of life scores between the intervention and usual care enhanced groups were not statistically significant. These findings indicate that structured support programs can positively impact the recovery experience for bladder cancer patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04055311, titled "Recovery Support for Bladder Cancer Patients and Caregivers", were posted on 2026-03-19 on clinicaltrials.gov.