NCT04634617

Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 310 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVE: 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

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

Interventions

Type	Name	Description
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2020-01-09
• Primary completion: 2027-04-11
• Completion: 2027-04-11
• First posted: 2020-11-18
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States