Exploring the Impact of Radiation Therapy on Pelvic Floor Disorders in Women Treated for Colorectal Cancer (RadPFD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Urinary Dysfunction - International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
研究概览
简要总结
Investigators propose a retrospective cohort study to examine the impact of radiation therapy on the global pelvic floor function of women who have completed the immediate surveillance period for colorectal cancer
详细描述
Primary Objective: To characterize the impact of radiation therapy on the lower urinary and bowel tract symptoms, (featuring urinary incontinence, irritative voiding symptoms, voiding dysfunction, bowel incontinence, and defecatory dysfunction) of female survivors of colorectal cancer 2-5 years after treatment.
Secondary Objectives:
- To characterize sexual dysfunctions present in female colorectal cancer survivors 2-5 years after treatment and to determine the impact of radiation therapy compared to surgical treatment alone.
- To examine the impact of radiation therapy on the sexual function of the partner of female survivors of colorectal cancer treated with radiation treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Living, female patients.
- •Age 18 or older with a diagnosis of colorectal cancer (current or past, regardless of Stage)-confirmed by pathology report - made between the years of 2015 and
- •History of treatment for colorectal cancer in the Wake Forest Baptist Health System.
- •Sexual partners of the above participants (subjects can participate even if they are not sexually active or if no sexual partner is available).
- •English speaking.
排除标准
- •No internet access.
- •Non-English speakers (validated instruments are only available in English).
结局指标
主要结局
Urinary Dysfunction - International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
时间窗: Up to 4 months
The ICIQ-FLUTS is a 12-item validated, self-administered questionnaire that is derived from the Bristol Female Lower Urinary Tract Symptoms (BF-LUTS) questionnaire and designed for use in women and to assess urinary symptoms and effects on quality of life. There are 3 subscales within this instrument to assess incontinence, voiding and filling. Investigators will specifically use the incontinence subscale as the primary outcome. The instrument is based on 5 questions, with possible answers on a 5-point scale (ranging from "never" to "all of the time"). Scoring is 0-48 with higher scores equaling to a greater bother with urinary dysfunction in participants.
次要结局
- PROMIS® Brief Profile Sexual Function and Satisfaction- Male or Female Partners(Up to 4 months)
- Short Form-12 Questionnaire - General Health and Well Being(Up to 4 months)
- Bowel Dysfunction - Modified Manchester Health Questionnaire(Up to 4 months)
- PROMIS® Brief Profile Sexual Function and Satisfaction (Female)(Up to 4 months)
- Dyadic Adjustment Scale-Short Form (DAS-7) Questionnaire - Couple Relationship(Up to 4 months)