Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

NCT ID: NCT05242770

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2022-11-26

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

Conditions

Gynecologic Cancer; Sexual Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Arm

Educational pamphlet with resources for sexual dysfunction

Group Type: PLACEBO_COMPARATOR

Control Arm

Intervention Type: 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.

Physical Therapy Arm

Physical therapy for sexual dysfunction.

Group Type: EXPERIMENTAL

Physical Therapy Arm

Intervention Type: 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.

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

Intervention Type: OTHER

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

Female Sexual Function Index (FSFI)

Intervention Type: OTHER

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

Exit Interview

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: OTHER

Female Sexual Function Index (FSFI)

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

Intervention Type: OTHER

Exit Interview

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne Danhauer, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Anya Menzies, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

WFBCCC 01421

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00079802

Identifier Type: -

Identifier Source: org_study_id