Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Pelvic floor distress (PFD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pelvic floor distress (PFD)
时间窗: Up to 1 year
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.
次要结局
未报告次要终点