Measuring Surgical Recovery After Radical Cystectomy

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03193970
Collaborator
(none)
20,000
11
247.1
1818.2
7.4

Study Details

Study Description

Brief Summary

The intent of this study is to establish a registry of post-surgical outcomes in patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating institutions. The goals of this initiative are to obtain a detailed baseline of multiple patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Post-Operative Recovery Registry

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Measuring Surgical Recovery After Radical Cystectomy
Actual Study Start Date :
Apr 30, 2015
Anticipated Primary Completion Date :
Dec 1, 2034
Anticipated Study Completion Date :
Dec 1, 2035

Arms and Interventions

Arm Intervention/Treatment
Bladder Cancer Patients Undergoing Radical Cystectomy

Prospective registry of bladder cancer patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating centers.

Behavioral: Post-Operative Recovery Registry
Multi-institutional prospective database of patients with bladder cancer undergoing radical cystectomy.

Outcome Measures

Primary Outcome Measures

  1. Post-Surgical Outcomes in Patients Undergoing Radical Cystectomy [3 months]

    Post-surgical outcomes determined from patient-reported assessment of symptom burden using the MD Anderson Symptom Inventory (MDASI-BLC form).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.
Exclusion Criteria:

N/A

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California - San Francisco San Francisco California United States 94143
2 Stanford University Stanford California United States 94305
3 Emory University Atlanta Georgia United States 30322
4 University of Chicago Chicago Illinois United States 60637
5 University of Kansas Medical Center Lawrence Kansas United States 66045
6 John Hopkins Medical Institutions Baltimore Maryland United States 21205
7 Spectrum Health Medical Group Grand Rapids Michigan United States 49503
8 Winthrop University Hospital Mineola New York United States 11501
9 University of Rochester Rochester New York United States 14611
10 University of Texas - Southwestern Dallas Texas United States 75390
11 University of Texas MD Anderson Cancer Center Houston Texas United States 77339

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Neema Navai, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT03193970
Other Study ID Numbers:
  • PA15-0026
  • NCI-2018-01433
First Posted:
Jun 21, 2017
Last Update Posted:
Dec 3, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by M.D. Anderson Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2020