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Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy (COMPETENCE)

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Perioperative geriatric assessment and intervention
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Frailty, Comprehensive Geriatric Assessment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with muscle-invasive bladder cancer and scheduled radical cystectomy. Planned urinary diversion with an ileal conduit Age ≥ 65 years. Patients considered frail by G8 screening tool (total score ≤14). Exclusion Criteria: Patients who refuse or are not able to provide informed consent. Patients who do not speak or understand Danish. Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC

Sites / Locations

  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional

Geriatric

Arm Description

Perioperative "care as usual" according to exciting principles and guidelines

Perioperative geriatric assessment and tailored interventions in relation to radical cystectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Days Alive and out of Hospital (DAOH)
Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery.
Complications
Number and severity (Clavien-Dindo grad I-V)
Length of stay
Number of days hospitalized during the index hospitalization
Hospital readmissions
Number of days admitted to hospital
Patient Quality of Life
Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L)
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)).
Mortality
Number
Chair stand test (CST)
Physical function measured by 30-s CST

Full Information

First Posted
December 20, 2022
Last Updated
July 27, 2023
Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus, Aalborg University Hospital, Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05679557
Brief Title
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
Acronym
COMPETENCE
Official Title
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus, Aalborg University Hospital, Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Frailty, Comprehensive Geriatric Assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, multicenter, randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
No Intervention
Arm Description
Perioperative "care as usual" according to exciting principles and guidelines
Arm Title
Geriatric
Arm Type
Experimental
Arm Description
Perioperative geriatric assessment and tailored interventions in relation to radical cystectomy.
Intervention Type
Other
Intervention Name(s)
Perioperative geriatric assessment and intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days Alive and out of Hospital (DAOH)
Description
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.
Time Frame
Within 90 days after cystectomy
Secondary Outcome Measure Information:
Title
Days Alive and out of Hospital (DAOH)
Description
Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery.
Time Frame
Within 30 days after cystectomy
Title
Complications
Description
Number and severity (Clavien-Dindo grad I-V)
Time Frame
Within 30 and 90 days after cystectomy
Title
Length of stay
Description
Number of days hospitalized during the index hospitalization
Time Frame
Within 90 days after surgery
Title
Hospital readmissions
Description
Number of days admitted to hospital
Time Frame
Within 30 and 90 days after cystectomy
Title
Patient Quality of Life
Description
Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L)
Time Frame
Within 30 and 90 days postoperatively
Title
Patient Quality of Life
Description
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)).
Time Frame
Within 30 and 90 days postoperatively
Title
Mortality
Description
Number
Time Frame
Within 30 and 90 days after cystectomy
Title
Chair stand test (CST)
Description
Physical function measured by 30-s CST
Time Frame
3 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with muscle-invasive bladder cancer and scheduled radical cystectomy. Planned urinary diversion with an ileal conduit Age ≥ 65 years. Patients considered frail by G8 screening tool (total score ≤14). Exclusion Criteria: Patients who refuse or are not able to provide informed consent. Patients who do not speak or understand Danish. Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jørgen Bjerggaard Jensen, Prof., DMSc
Phone
+45 78452617
Email
Bjerggaard@skejby.rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina S Prior, MD, PhD stud
Email
katans@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørgen S Bjerggaard Jensen, Prof., DMSc
Organizational Affiliation
Aarhus University Hospital and Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lasse Bro, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

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