Radiation Therapy on Pelvic Floor Disorders in Women

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Exploring the Impact of Radiation Therapy on Pelvic Floor Disorders in Women Treated for Colorectal Cancer (RadPFD)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: REDCap Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 2018. 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. Exclusion Criteria: No internet access. Non-English speakers (validated instruments are only available in English).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery Only Group<br>Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link. | Other: REDCap Questionnaires<br>* Once consent is obtained, the participants will be routed to a REDCap secure link. Participants will complete a questionnaires regarding demographics and medical history. Participants will also complete validated questionnaires regarding their lower urinary and bowel tract function and sexual health- International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Modified Manchester Health Questionnaire (MMHQ), PROMIS® v2.0 Brief Profile Sexual Function and Satisfaction (Female) and SF-12 ® .<br>|
| Surgery and Radiation Therapy Group<br>Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link. | Other: REDCap Questionnaires<br>* Once consent is obtained, the participants will be routed to a REDCap secure link. Participants will complete a questionnaires regarding demographics and medical history. Participants will also complete validated questionnaires regarding their lower urinary and bowel tract function and sexual health- International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Modified Manchester Health Questionnaire (MMHQ), PROMIS® v2.0 Brief Profile Sexual Function and Satisfaction (Female) and SF-12 ® .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Dysfunction - International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) | 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. | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS® Brief Profile Sexual Function and Satisfaction (Female) | This is a 14-item validated questionnaire that has been validated for use in cancer populations to assess female sexual function. Scoring is 0-100 with lower numbers indicating worse sexual function. | Up to 4 months | 
| Bowel Dysfunction - Modified Manchester Health Questionnaire | This is a 31-item patient reported outcome measure that is designed to assess degree and severity of bowel dysfunction and the impact of this dysfunction on quality of life. Scoring is 0-100 with higher scores indicating worse bowel function. | Up to 4 months | 
| PROMIS® Brief Profile Sexual Function and Satisfaction- Male or Female Partners | The PROMIS® Brief Profile Sexual Function and Satisfaction is an 11-item validated questionnaire that has been validated in a heterogeneous population to assess partner sexual function. Scoring is 0-100 with lower numbers indicating worse sexual function. | Up to 4 months | 
| Dyadic Adjustment Scale-Short Form (DAS-7) Questionnaire - Couple Relationship | This is a 7-item questionnaire to assess the quality of dyadic relationship designed for cohabitating or married couples. Score range is 0-36 with higher scores indicating better function. | Up to 4 months | 
| Short Form-12 Questionnaire - General Health and Well Being | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Scoring is 0-100 with higher scores indicating better function in the participant. | Up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Voiding dysfunction, Survivors of colorectal cancer, Lower bowel tract symptoms, Urinary incontinence, Irritative voiding symptoms, Bowel incontinence, Defecatory dysfunction, Lower urinary tract symptoms