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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
28
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.
University of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGEvaluate 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.
Time frame: 3 months after Radiation Therapy Treatment
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.
Time frame: 3 months after Radiation Therapy Treatment
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.
Time frame: 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.
Time frame: 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. 1. Participant reported compliance with home exercise course from baseline through 3 months will be collected and analyzed for rate of compliance against protocol usage. 2. Reported dilator compliance will be compared to reported historical compliance rates for this SOC recommendation
Sarah Sittenfeld
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Time frame: 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.
Time frame: At Baseline and at 3 months after Radiation Therapy Treatment