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

Quality of Life and Function of Patients After Hemipelvectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Primary Pelvic Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Electronic Health Record Review; Other: Physical Performance Testing; Other: Quality-of-Life Assessment

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: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Valerae O Lewis; Phone Number: 713-792-5073; Email: volewis@mdanderson.org

Study Locations

• United States
  • 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: No

• Sampling Method: Non-Probability Sample

Study Population

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

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?

Number of groups / cohorts

1

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.

Other: Questionnaire Administration; Complete questionnaire; Other: Electronic Health Record Review; Undergo medical record review; Other: Physical Performance Testing; Undergo physical performance testing; Other Names: Physical Fitness Testing; Physical Function Testing; Other: Quality-of-Life Assessment; Complete assessments; Other Names: Quality of Life Assessment

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	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: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Valerae O Lewis, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center website

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2013
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Pelvic Neoplasms; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Respiratory Function Tests; Ergometry; Exercise Test
• 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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No