Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors

NCT04634617 | Active Not Recruiting

• 2 other identifiers: 2018-0242NCI-2019-08260
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies pelvic floor dysfunction and quality of life in uterine cancer survivors. Using questionnaires may help researchers learn more about the sexual function and quality of life in uterine cancer survivors.

Conditions

Endometrial Carcinoma; Malignant Uterine Neoplasm; Uterine Corpus Cancer; Uterine Corpus Sarcoma

Outcome Measures

Primary Outcomes (1)

• Pelvic floor distress (PFD)

  Measured by the Pelvic Floor Distress Inventory-20. Descriptive statistics (i.e. frequencies, percentages, medians, ranges, means, standard deviations, measures of skewness and kurtosis), including 95% confidence intervals (CIs) will be computed for the measures derived by study cohort. Prevalence estimates along with exact 95% CIs will be computed. Logistic regression analysis will be used to assess the odds of PFD for treatment cohorts relative to the cohort of patient controls.

  Up to 1 year

Study Arms (1)

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.

Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Complete questionnaires

Observational (questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with uterine cancer treated with surgery +/- radiation at MD Anderson between 2006 and 2017 and patients who have never been diagnosed with any cancer other than non-melanomatous skin cancers and have undergone hysterectomy/bilateral-salpingo-oophorectomy (BSO) for benign reasons between 2006 and 2017

You may qualify if:

• Patients with uterine cancer (including endometrial and uterine carcinoma or sarcoma) treated with surgery +/- radiation at MD Anderson between 2006 and 2017
• 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

You may not qualify if:

• Patients with cancer recurrence, as this will affect their current quality of life
• 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

Sponsors & Collaborators

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

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lilie L Lin

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 18, 2020
• Study Start: January 9, 2020
• Primary Completion (Estimated): April 11, 2027
• Study Completion (Estimated): April 11, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)