Quality of Life and Function of Patients With Pelvic Tumors After Undergoing Hemipelvectomy

Recruiting

• Conditions: Malignant Primary Pelvic Neoplasm
• Interventions: Other: Electronic Health Record Review; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT05134142
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This study aims to determine the functional outcomes of patients who underwent internal hemipelvectomy with or without reconstruction or external hemipelvectomy for pelvic tumors. Learning about the outcomes of these patients may help researchers determine the long-term effects of different types of hemipelvectomy procedures and may help improve quality of life.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-03-27
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-11-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients within the institution who have undergone or will undergo a hemipelvectomy

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (Physical tests, questionnaires, record review)	Questionnaire Administration	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.
Observational (Physical tests, questionnaires, record review)	Electronic Health 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.
Observational (Physical tests, questionnaires, record review)	Physical Performance Testing	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.
Observational (Physical tests, questionnaires, record review)	Quality-of-Life Assessment	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.

Primary Outcome Measures

Name	Time	Method
Functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States