- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05134142
Quality of Life and Function of Patients With Pelvic Tumors After Undergoing Hemipelvectomy
Quality of Life and Function of Patients After Hemipelvectomy
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. To determine functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy.
SECONDARY OBJECTIVES:
I. To determine factors that influence the functional outcomes of these patients following surgery.
II. Assess sexual and urinary function in patients who have undergone internal or external hemipelvectomy.
III. Determine whether type of surgery influences long-term sexual and urinary function.
OUTLINE:
Patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years. Patients who are 1 year out from surgery complete pain-related questionnaires once. Patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Valerae O Lewis
- Phone Number: 713-792-5073
- Email: volewis@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Valerae O. Lewis
- Phone Number: 713-792-5073
-
Principal Investigator:
- Valerae O. Lewis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients within the institution who have undergone or will undergo a hemipelvectomy
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (Physical tests, questionnaires, record review)
Patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years.
Patients who are 1 year out from surgery complete pain-related questionnaires once.
Patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.
|
Complete questionnaire
Undergo medical record review
Undergo physical performance testing
Other Names:
Complete assessments
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy
Time Frame: Through study completion, average of 1 year
|
All continuous variables including the scoring systems will be described as mean with standard deviation or median with range.
Frequencies and percentages will be obtained for all categorical variables.
Pediatric participants' data measures will be collected and analyzed separately from the adult populations.
|
Through study completion, average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Valerae O Lewis, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA12-1046 (Other Identifier: M D Anderson Cancer Center)
- NCI-2021-11297 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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