Status:
COMPLETED
Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Gynecologic Cancer
Sexual Dysfunction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to investigate the use of pelvic physical therapy for gynecologic cancer survivors who report sexual dysfunction. Physical therapy experts believe that a full 10-...
Detailed Description
Primary Objective(s): To determine the feasibility of an intensive pelvic physical therapy intervention with gynecologic cancer survivors reporting sexual dysfunction. Feasibility will be determined b...
Eligibility Criteria
Inclusion
- History of cervical, ovarian/fallopian tube/primary peritoneal, uterine, or vulvar/vaginal cancer, regardless of stage or amount of prior therapy. Patients must have completed radiation therapy 12 weeks prior enrollment. Patients must be at least 12 weeks remote from surgery. There is no minimum time after completion of chemotherapy for enrollment. There is no upper limit of time from treatment.
- History of treatment for gynecological cancer - surgery, radiation, chemotherapy, or combination of therapies.
- Screen positive for sexual dysfunction based on answers to the Brief Sexual Symptom Checklist for Women. A patient screens positive if they answer "no" to the first question (Are you satisfied with your sexual function?) and if they select any answer other than "a" in the third question (Mark which of the following problems you are having). The other questions do not impact whether a patient screens positive or negative. They do not have an impact on study eligibility.
- English-speaking. Due to the developmental nature of this study, assessing feasibility with a small number of patients, we do not have all response tools and questionnaires translated into multiple languages. In a future larger study, it will be important to translate all documents into multiple languages in order to include non-English speakers.
- Age ≥18 years.
Exclusion
- Active pelvic infection.
- Presence of vaginal fistula.
- Deemed not suitable for pelvic physical therapy based on physician assessment. If there is suspicion for infection, disease recurrence, or other concerning medical findings that necessitate further evaluation and work up at that time.
- Evidence of active cancer.
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05242770
Start Date
March 28 2022
End Date
November 26 2022
Last Update
February 13 2024
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157