Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

Bladder Cancer Clinical Trial

— COMPETENCE  

Official title:

Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679557
• Other study ID #: 1-10-72-182-22
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: July 2023
• Source: Aarhus University Hospital
• Contact: Jørgen Bjerggaard Jensen, Prof., DMSc
• Phone: +45 78452617
• Email: Bjerggaard[@]skejby.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). The aim of the study is to investigate the effect of perioperative Comprehensive Geriatric Assessment (CGA) and tailored intervention in older, frail patients with bladder cancer undergoing RC.

Description:

Patients will be randomized 1:1 and allocated into either control or intervention study arm. The control group will receive perioperative "care as usual" according to exciting principles and guidelines. The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• Perioperative geriatric assessment and intervention
The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment (CGA) and tailored interventions, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Aarhus University Hospital	Aalborg University Hospital, Odense University Hospital, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days Alive and out of Hospital (DAOH)	Primary outcome will be DAOH counted from day of surgery until 90 days after surgery. DAOH as an endpoint combines the duration of hospital stay, the burden of subsequently readmissions and mortality, and hence is an expression for the expected reduction in medical postoperative complications.	Within 90 days after cystectomy
Secondary	Days Alive and out of Hospital (DAOH)	Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery.	Within 30 days after cystectomy
Secondary	Complications	Number and severity (Clavien-Dindo grad I-V)	Within 30 and 90 days after cystectomy
Secondary	Length of stay	Number of days hospitalized during the index hospitalization	Within 90 days after surgery
Secondary	Hospital readmissions	Number of days admitted to hospital	Within 30 and 90 days after cystectomy
Secondary	Patient Quality of Life	Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L)	Within 30 and 90 days postoperatively
Secondary	Patient Quality of Life	Quality of Life evaluated by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30/BLM30 (muscle invasive bladder cancer)).	Within 30 and 90 days postoperatively
Secondary	Mortality	Number	Within 30 and 90 days after cystectomy
Secondary	Chair stand test (CST)	Physical function measured by 30-s CST	3 weeks postoperatively