Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

Feasibility of Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Sexual Dysfunction
• Intervention / Treatment: Other: Control Arm; Other: Physical Therapy Arm; Other: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30); Other: Female Sexual Function Index (FSFI); Other: Exit Interview

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 PPT 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm; Educational pamphlet with resources for sexual dysfunction	Other: Control Arm; Participants randomized to this arm will only receive educational pamphlets with resources for sexual dysfunction and will not participate in physical therapy. Participants will be contacted at 3 months and 6 months to fill out two questionnaires about sexual function and quality of life. After 6months, if participants desire a referral to physical therapy, investigators will provide a referral.
Experimental: Physical Therapy Arm; Physical therapy for sexual dysfunction.	Other: Physical Therapy Arm; Participants will receive a referral to begin a pelvic physical therapy regimen. Participants will complete the sexual function and quality of life questionnaires after completion of the physical therapy regimen and again 3 months after. There will be a brief exit interview.; Other: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30); Questionnaire designed to measure cancer patients' physical, psychological and social functions; Other: Female Sexual Function Index (FSFI); 19-item self-report inventory designed to assess female sexual function.; Other: Exit Interview; 11-item questionnaire for participants to give feedback to investigators about teir experience with the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accrual to Study Intervention	Accrual is the number of participants that screen positive for sexual dysfunction, are eligible for entry into the study and consent to participate in the study.	At baseline
Number of Participants Retained to Study Intervention	Retention is participants' attendance of pelvic physical therapy visits.	3 months after completion of physical therapy.
Adherence to Study Intervention	Adherence is the number of enrolled participants completing the full series of questionnaires.	3 months after completion of physical therapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Function Index (FSFI) Questionnaire	The questionnaire is comprised of six domains: desire [two items], arousal [four items], lubrication [four items], orgasm, satisfaction, pain [three items each]. Score range is 1 to 5. The FSFI total score is the sum of the 6 domain/subscale scores and has a maximum score of 36. Higher scores indicate better functioning. At each time point, 2-sample t-tests or Wilcoxon rank sum tests will be used to compare sexual function between groups. If feasible, mixed effects models with random intercept will be used to compare sexual function between groups over time. Intervention groups, visits, and intervention groups by visits will be included in the model. Contrasts will be used to compare sexual function between groups at each time point.	(T0) at time of randomization, (T1) after completion of the 10-week PPT regimen - 3 months after randomization, and (T2) 3 months after T1.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire	The EORTC QLQ-C30 questionnaire will be completed three times during study intervention and is patient reported to assess sexual function and health-related quality of life. Score range is 0 to 100. A high score for a functional scale represents a high/ healthy level of functioning; a high score for the global health status /quality of life represents a high quality of life; a high score for a symptom scale/item represents a high level of symptomatology / problems. At each time point, 2-sample t-tests or Wilcoxon rank sum tests will be used to compare sexual function between groups. If feasible, mixed effects models with random intercept will be used to compare sexual function between groups over time. Intervention groups, visits, and intervention groups by visits will be included in the model. Contrasts will be used to compare sexual function between groups at each time point.	(T0) at time of randomization, (T1) after completion of the 10-week PPT regimen - 3 months after randomization, and (T2) 3 months after T1.

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Anya Menzies, PhD, Wake Forest Baptist Comprehensive Cancer Center; Principal Investigator: Suzanne K Danhauer, PhD, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): September 14, 2022
• Study Completion (Actual): September 14, 2022

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological
• Other Study ID Numbers: IRB00079802; P30CA012197 (U.S. NIH Grant/Contract); WFBCCC 01421 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No