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This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy.
This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy. The objective is to determine the rate of fecal incontinence at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. The primary endpoint of this study is the rate of fecal incontinence at 3 months after RT utilizing the EORTC-QLQ CX24 validated survey. A score of 1 or higher will be classified as having incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic floor physical therapy | Experimental | Patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor physical therapy | Procedure | Four weeks after completion of RT, patients will begin a standardized pelvic floor PT course. The protocol will include two 1-hour physical therapy appointments focused on pelvic floor muscle training, dilator training and education. These sessions will be 4 weeks apart and performed by a pelvic floor physical therapist. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate fecal incontinence via EORTC-QLQ CX24 validated survey | To determine the rate of fecal incontinence at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. The primary endpoint of this study is the rate of fecal incontinence at 3 months after RT utilizing the EORTC-QLQ CX24 validated survey. A score of 1 or higher will be classified as having incontinence. | 3 months after Radiation Therapy Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of urinary incontinence via EORTC-QLQ CX24 | 1. To determine the rates of urinary incontinence 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. a. Secondary endpoints will include rates of urinary incontinence as obtained from the EORTC-QLQ CX24 at 3-months post-treatment. | 3 months after Radiation Therapy Treatment |
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Inclusion Criteria:
Exclusion Criteria:
1. Participants must be female.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCCC Clinical Trials Office | Contact | 513-584-7698 | cancer@uchealth.com | |
| Sarah Sittenfeld | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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This is a single arm phase II study in which 28 patients who will be undergoing definitive pelvic external beam radiation therapy for cervical cancer will receive pelvic floor physical therapy 4 weeks after completing radiation therapy.
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|
| Sexual symptoms via EORTC-QLQ CX24 | 1. To determine sexual symptoms at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. a. Secondary endpoints will include rates of sexual symptoms as obtained from the EORTC-QLQ CX24 at 3-months post-treatment. | 3 months after Radiation Therapy Treatment |
| QOL as obtained from the EORTC-QLQ CX24 | 1. To determine QOL at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. a. Secondary endpoints will include QOL as obtained from the EORTC-QLQ CX24 at 3-months post-treatment. | 3 months after Radiation Therapy Treatment |
| Compliance rates with recommended standard of care schedule of dilator via self reports | 2. To determine compliance rates with recommended standard of care schedule of dilator use at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies.
| 3 months after Radiation Therapy Treatment |
| Evaluate changes in pelvic floor muscle function using the validated Brink scale | 3. To evaluate changes in pelvic floor muscle function at 3 months after RT in women undergoing pelvic radiation for gynecologic malignancies. a. Descriptive analysis of pelvic floor muscle function (strength, coordination, endurance objectively graded using the validated Brink scale) at baseline and follow up, along with participant reported compliance with home exercise course will also be collected and reported. | At Baseline and at 3 months after Radiation Therapy Treatment |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |