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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 01620 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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IRB closure, slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery Only Group | Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link. |
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| Surgery and Radiation Therapy Group | Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REDCap Questionnaires | Other | 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 ® . |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Female survivors of colorectal cancer and their partners.
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| Name | Affiliation | Role |
|---|---|---|
| Candace Parker-Autry, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27103 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D014549 | Urinary Incontinence |
| D005242 | Fecal Incontinence |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |