Clinical trial · Observational
Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors
NCT04634617CI-TRIAL-00112189active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Uterine Neoplasm | Malignant Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | ALIAS | 0.90 |
| Uterine Corpus Sarcoma | Uterine Corpus Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (questionnaires)
- description
- 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.
- interventionNames
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Pelvic floor distress (PFD)
- timeFrame
- Up to 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.