Improving care for older patients undergoing bladder cancer surgery
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
This study tests if a detailed health check and support from a geriatric team can help older patients with bladder cancer have better surgery outcomes and recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Trial ID | NCT05679557 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a Comprehensive Geriatric Assessment (CGA) on older patients with muscle-invasive bladder cancer scheduled for radical cystectomy. Participants will be randomly assigned to either a control group receiving standard care or an intervention group receiving a thorough preoperative geriatric assessment and tailored interventions. The intervention aims to optimize health issues that may affect surgical outcomes, with ongoing support from a geriatric team during the postoperative period. This approach emphasizes interdisciplinary collaboration to enhance patient care.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 and above with muscle-invasive bladder cancer who are considered frail based on the G8 screening tool.
Not a fit: Patients who are not frail, do not speak or understand Danish, or are undergoing other major surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce perioperative complications and improve outcomes for older patients undergoing bladder cancer surgery.
How similar studies have performed: Other studies have shown promising results with similar geriatric assessment approaches in surgical settings, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with muscle-invasive bladder cancer and scheduled radical cystectomy. 2. Planned urinary diversion with an ileal conduit 3. Age ≥ 65 years. 4. Patients considered frail by G8 screening tool (total score ≤14). Exclusion Criteria: 1. Patients who refuse or are not able to provide informed consent. 2. Patients who do not speak or understand Danish. 3. Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC
Where this trial is running
Odense
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Jørgen S Bjerggaard Jensen, Prof., DMSc — Aarhus University Hospital and Aarhus University
- Study coordinator: Jørgen Bjerggaard Jensen, Prof., DMSc
- Email: katans@rm.dk
- Phone: +45 30915525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.