Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-08260 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0242 | Other Identifier | M D Anderson Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Administration | Other | Complete questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Patients with uterine cancer (including endometrial and uterine carcinoma or sarcoma) treated with surgery +/- radiation at MD Anderson between 2006 and 2017
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:
Not provided
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lilie L Lin | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |