Clinical trial NCT05242770: Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors
Official title: Feasibility of Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Sexual Dysfunction
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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-week regimen is necessary for true improvement of symptoms. Investigators aim to see if this tense regimen is feasible for survivors. Investigators also aim to see if patients have an improvement in their sexual function and quality of life.

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 by accrual, retention, and adherence.

Secondary Objective(s):

* To demonstrate preliminary efficacy of the pelvic physical therapy intervention on sexual function in gynecologic cancer survivors. Sexual function will be measured three times: at time of randomization (T0), after completion of the 10-week pelvic physical therapy regimen - 3 months after randomization (T1), and 3 months after T1 (T2).
* To demonstrate preliminary efficacy of the pelvic physical therapy intervention on health-related quality of life in gynecologic cancer survivors. Quality of life will be measured at three times (T0) at time of randomization, (T1) after completion of the 10-week pelvic physical therapy regimen - 3 months after randomization, and (T2) 3 months after T1

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Accrual to Study Intervention
timeFrame: At baseline
measure: Number of Participants Retained to Study Intervention
timeFrame: 3 months after completion of physical therapy.
measure: Adherence to Study Intervention
timeFrame: 3 months after completion of physical therapy.
Secondary outcomes:
measure: Female Sexual Function Index (FSFI) Questionnaire
timeFrame: At time of randomization, 3 months after randomization and 3 months after completion of physical therapy regimen
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
timeFrame: At time of randomization, 3 months after randomization and 3 months after completion of physical therapy regimen
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Suzanne Danhauer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Anya Menzies, PhD
role: PRINCIPAL_INVESTIGATOR
References: