Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors
NCT ID: NCT04634617
Last Updated: 2025-11-10
Study Results
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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ACTIVE_NOT_RECRUITING
310 participants
OBSERVATIONAL
2020-01-09
2027-04-11
Brief Summary
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Detailed Description
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I. To estimate and compare the prevalence of pelvic floor dysfunction in uterine cancer survivors by modality of treatment and to compare with a control group with no history of cancer using the Pelvic Floor Distress Inventory (PFDI).
SECONDARY OBJECTIVES:
I. To compare the degree of sexual dysfunction in uterine cancer survivors by modality of treatment using the Female Sexual Function Index (FSFI) as a continuous measure, and to compare to a non-cancer control group.
II. To compare the long term quality of life (QoL) (using the FSFI, the Pelvic Floor Impact Questionnaire \[PFIQ\], Functional Assessment of Cancer Therapy-Endometrial Cancer \[FACT-En\], Brief Pain Inventory \[BPI\], Alzheimer's Disease Assessment Scale \[ADAS\]/Cancer Rehabilitation Evaluation System for Research \[CARES\] dating scale and Menopausal survey) of patients who were treated with surgery and radiotherapy versus surgery alone (with or without chemotherapy), and to compare to a control group with no history of cancer.
III. To evaluate associations between dose volume parameters of organs at risk and pelvic floor symptoms using the PFIQ and PFDI.
IV. To evaluate associations between the radiation and surgical technique and quality of life (including pelvic symptoms and sexual function using the FSFI, PFIQ, PFDI, and FACT-En).
OUTLINE:
Patients complete questionnaires over 45-60 minutes consisting of demographic, treatment, lifestyle, disease, and comorbidity questions, as well as multiple study instruments assessing quality of life as it pertains to common toxicities of uterine cancer treatment.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Observational (questionnaires)
Patients complete questionnaires over 45-60 minutes consisting of demographic, treatment, lifestyle, disease, and comorbidity questions, as well as multiple study instruments assessing quality of life as it pertains to common toxicities of uterine cancer treatment.
Questionnaire Administration
Complete questionnaires
Interventions
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Questionnaire Administration
Complete questionnaires
Eligibility Criteria
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Inclusion Criteria
* Eligible surgeries include laparoscopic or robotic assisted abdominal total hysterectomy, total abdominal hysterectomy, and vaginal hysterectomy with or without pelvic node dissection, with or without omentectomy or omental biopsies
* In addition, patients must have had all WITH bilateral-salpingo-oophorectomy (BSO), either during their surgery or in a previous or subsequent (within 3 months of endometrial cancer diagnosis) surgery
* Patients have had at least one year of follow-up
* Patients have not had any recurrence of disease
* Patients must be able to complete the survey of their own volition
* Patients must be able to read and speak English fluently
* CONTROL GROUP: Patients have never been diagnosed with any cancer other than non-melanomatous skin cancers
* CONTROL GROUP: Patient has undergone hysterectomy/BSO for benign reasons between 2006 and 2017
* CONTROL GROUP: Patients must be able to complete the survey of their own volition
* CONTROL GROUP: Patients must be able to speak and read English fluently
Exclusion Criteria
* Patients with additional pelvic surgery at the time of their hysterectomy (for example pelvic exenteration, urostomy placement, etc.)
* Patients with a secondary primary cancer (including cervical cancer), as this will affect their current quality of life. Patients may have either squamous cell or basal cell carcinoma of the skin
* Neurocognitive deficits that render patients unable to complete the survey on their own
* Patients who have not yet had removal of their bilateral ovaries
* Preoperative radiotherapy prior to hysterectomy
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lilie L Lin
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2019-08260
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0242
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0242
Identifier Type: -
Identifier Source: org_study_id