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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05134142
Collaborator
National Cancer Institute (NCI) (NIH)
200
Enrollment
1
Location
105.2
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Electronic Health Record Review
  • Other: Physical Performance Testing
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy.
SECONDARY OBJECTIVES:

  1. To determine factors that influence the functional outcomes of these patients following surgery.

  2. Assess sexual and urinary function in patients who have undergone internal or external hemipelvectomy.

  3. 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Quality of Life and Function of Patients After Hemipelvectomy
Actual Study Start Date :
Mar 27, 2013
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm 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: 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

    • Other: Questionnaire Administration
    Complete questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients within the institution who have undergone or will undergo a hemipelvectomy
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Valerae O Lewis, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05134142
    Other Study ID Numbers:
    • PA12-1046
    • NCI-2021-11297
    • PA12-1046
    First Posted:
    Nov 24, 2021
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    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
    Additional relevant MeSH terms:
    Pelvic Neoplasms

    Study Results

    No Results Posted as of Nov 24, 2021