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

NCT ID: NCT05134142

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-27

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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Malignant Primary Pelvic Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Electronic Health Record Review

Intervention Type OTHER

Undergo medical record review

Physical Performance Testing

Intervention Type OTHER

Undergo physical performance testing

Quality-of-Life Assessment

Intervention Type OTHER

Complete assessments

Questionnaire Administration

Intervention Type OTHER

Complete questionnaire

Interventions

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Electronic Health Record Review

Undergo medical record review

Intervention Type OTHER

Physical Performance Testing

Undergo physical performance testing

Intervention Type OTHER

Quality-of-Life Assessment

Complete assessments

Intervention Type OTHER

Questionnaire Administration

Complete questionnaire

Intervention Type OTHER

Other Intervention Names

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Physical Fitness Testing Physical Function Testing Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerae O Lewis

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Valerae O Lewis

Role: CONTACT

Phone: 713-792-5073

Email: [email protected]

Facility Contacts

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Valerae O. Lewis

Role: primary

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center website

Other Identifiers

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NCI-2021-11297

Identifier Type: REGISTRY

Identifier Source: secondary_id

PA12-1046

Identifier Type: OTHER

Identifier Source: secondary_id

PA12-1046

Identifier Type: -

Identifier Source: org_study_id