Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy (COMPETENCE)

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: Perioperative geriatric assessment and intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jørgen Bjerggaard Jensen, Prof., DMSc; Phone Number: +45 78452617; Email: Bjerggaard@skejby.rm.dk
• Study Contact Backup: Name: Katharina S Prior, MD, PhD stud; Email: katans@rm.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Lasse Bro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional; Perioperative "care as usual" according to exciting principles and guidelines
Experimental: Geriatric; Perioperative geriatric assessment and tailored interventions in relation to radical cystectomy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complications	Number and severity (Clavien-Dindo grad I-V)	Within 30 and 90 days after cystectomy
Length of stay	Number of days hospitalized during the index hospitalization	Within 90 days after surgery
Hospital readmissions	Number of days admitted to hospital	Within 30 and 90 days after cystectomy
Mortality	Number	Within 30 and 90 days after cystectomy
Chair stand test (CST)	Physical function measured by 30-s CST	3 weeks postoperatively
Patient Quality of Life	Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L)	Within 30 and 90 days postoperatively
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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Odense University Hospital; University of Aarhus; Aalborg University Hospital
• Investigators: Principal Investigator: Jørgen S Bjerggaard Jensen, Prof., DMSc, Aarhus University Hospital and Aarhus University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Frailty; Comprehensive Geriatric Assessment
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 1-10-72-182-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No