Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

NCT05242770 | Completed

• 3 other identifiers: IRB00079802WFBCCC 01421P30CA012197
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Sexual Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Female Sexual Function Index (FSFI) Questionnaire

  (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

  (T0) at time of randomization, (T1) after completion of the 10-week PPT regimen - 3 months after randomization, and (T2) 3 months after T1.

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

Educational pamphlet with resources for sexual dysfunction

Other: Control Arm

Physical Therapy Arm

EXPERIMENTAL

Physical therapy for sexual dysfunction.

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

Interventions

Control Arm OTHER

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.

Control Arm

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) OTHER

Questionnaire designed to measure cancer patients' physical, psychological and social functions

Physical Therapy Arm

Physical Therapy Arm OTHER

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.

Physical Therapy Arm

Female Sexual Function Index (FSFI) OTHER

19-item self-report inventory designed to assess female sexual function.

Physical Therapy Arm

Exit Interview OTHER

11-item questionnaire for participants to give feedback to investigators about teir experience with the intervention.

Physical Therapy Arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Suzanne K Danhauer, PhD

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Anya Menzies, PhD

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 16, 2022
• Study Start: March 28, 2022
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2022
• Last Updated: March 23, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)