COMPETENCE: Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05679557
• Collaborator: University of Aarhus (Other), Aalborg University Hospital (Other), Odense University Hospital (Other)
• Enrollment: 140
• Arms: 2
• Anticipated Duration (Months): 49.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Other: Perioperative geriatric assessment and intervention	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A prospective, multicenter, randomized clinical trialA prospective, multicenter, randomized clinical trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Days Alive and out of Hospital (DAOH) [Within 90 days after cystectomy]

   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.

Secondary Outcome Measures

1. Days Alive and out of Hospital (DAOH) [Within 30 days after cystectomy]

   Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery.

2. Complications [Within 30 and 90 days after cystectomy]

   Number and severity (Clavien-Dindo grad I-V)

3. Length of stay [Within 90 days after surgery]

   Number of days hospitalized during the index hospitalization

4. Hospital readmissions [Within 30 and 90 days after cystectomy]

   Number of days admitted to hospital

5. Patient Quality of Life [Within 30 and 90 days postoperatively]

   Quality of Life will be evaluated by the EuroQol 5D questionnaire (EQ-ED-5L)

6. Patient Quality of Life [Within 30 and 90 days postoperatively]

   Quality of Life will also be evaluated by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30/BLM30 (muscle invasive bladder cancer)).

7. Mortality [Within 30 and 90 days after cystectomy]

   Number

8. Chair stand test (CST) [3 weeks postoperatively]

   Physical function measured by 30-s CST

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aarhus University Hospital
• University of Aarhus
• Aalborg University Hospital
• Odense University Hospital

Investigators

• Principal Investigator: Jørgen S Bjerggaard Jensen, Prof., DMSc, Aarhus University Hospital and Aarhus University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jørgen Bjerggaard Jensen, Professor, DMSc, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT05679557
• Other Study ID Numbers: 1-10-72-182-22
• First Posted: Jan 11, 2023
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jørgen Bjerggaard Jensen, Professor, DMSc, Aarhus University Hospital: Frailty; Comprehensive Geriatric Assessment
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Feb 1, 2023