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

Full Title of Study: “Quality of Life and Function of Patients After Hemipelvectomy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 31, 2021

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary 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
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

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

  • None

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Valerae O Lewis, Principal Investigator, M.D. Anderson Cancer Center
  • Overall Contact(s)
    • Valerae O Lewis, 713-792-5073, volewis@mdanderson.org

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