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Recruiting NCT05134142

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

Observational Malignant Primary Pelvic Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electronic Health Record Review, Physical Performance Testing, Quality-of-Life Assessment, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Malignant Primary Pelvic Neoplasm. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Quality of Life and Function of Patients After Hemipelvectomy

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\- None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT05134142 · PA12-1046 · NCI-2021-11297 · PA12-1046

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗