Gynecologic CancerNCT05242770

Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

A study testing Physical Therapy Arm, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and Female Sexual Function Index (FSFI) in people with Gynecologic Cancer and Sexual Dysfunction, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Gynecologic Cancer, Sexual Dysfunction
What is being tested?: Physical Therapy Arm, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) and Female Sexual Function Index (FSFI)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 28 Mar 2022to 10 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: Control Arm, Physical Therapy Arm, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Female Sexual Function Index (FSFI), Exit Interview
Medical subject headings: Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control ArmOther
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 ArmOther
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)Other
Questionnaire designed to measure cancer patients' physical, psychological and social functions
Female Sexual Function Index (FSFI)Other
19-item self-report inventory designed to assess female sexual function.
Exit InterviewOther
11-item questionnaire for participants to give feedback to investigators about teir experience with the intervention.

Study groups in NCT05242770
Study group	Role	What they receive
Control Arm	Placebo comparator	Educational pamphlet with resources for sexual dysfunction Receives: Other: Control Arm
Physical Therapy Arm	Experimental	Physical therapy for sexual dysfunction. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline
Number of Participants Retained to Study Intervention
Retention is participants' attendance of pelvic physical therapy visits.
Measured: 3 months after completion of physical therapy.
Adherence to Study Intervention
Adherence is the number of enrolled participants completing the full series of questionnaires.
Measured: 3 months after completion of physical therapy.

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 202210 Apr 2023

First posted16 Feb 2022
Study start28 Mar 2022
Primary completion10 Apr 2023
Study completion10 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gynecologic CancerStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05242770
Sponsor's protocol ID: IRB00079802
Other IDs: WFBCCC 01421, P30CA012197
Status last verified: Sep 2026
First submitted: 26 Jan 2022
Last updated: 29 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gynecologic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors
ClinicalTrials.gov ID: NCT05242770
Acronym / sponsor ID: IRB00079802
Conditions: Gynecologic Cancer, Sexual Dysfunction
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 28 Mar 2022 (actual)
Primary completion: 10 Apr 2023 (actual)
Study completion: 10 Apr 2023 (actual)
First posted: 16 Feb 2022 (actual)
Results: Posted 29 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Arm	Placebo comparator	Other: Control ArmEducational pamphlet with resources for sexual dysfunction
Physical Therapy Arm	Experimental	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 InterviewPhysical therapy for sexual dysfunction.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Control ArmParticipants 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.	Other	Control Arm
Physical Therapy ArmParticipants 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	Physical Therapy Arm
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	Physical Therapy Arm
Female Sexual Function Index (FSFI)19-item self-report inventory designed to assess female sexual function.	Other	Physical Therapy Arm
Exit Interview11-item questionnaire for participants to give feedback to investigators about teir experience with the intervention.	Other	Physical Therapy Arm

Primary outcome

Accrual to Study Intervention
Time frame: At baseline
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.
Number of Participants Retained to Study Intervention
Time frame: 3 months after completion of physical therapy.
Retention is participants' attendance of pelvic physical therapy visits.
Adherence to Study Intervention
Time frame: 3 months after completion of physical therapy.
Adherence is the number of enrolled participants completing the full series of questionnaires.

2 secondary outcomes

Female Sexual Function Index (FSFI) Questionnaire
Time frame: (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
Time frame: (T0) at time of randomization, (T1) after completion of the 10-week PPT regimen - 3 months after randomization, and (T2) 3 months after T1.

Results and safety

Results posted to the registry on 29 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Arm	10	8
Physical Therapy Arm	10	2

Primary outcome: Accrual to Study Intervention

Time frame: At baseline. Count of participants. Unit: Participants

Measure	Control Arm n = 10	Physical Therapy Arm n = 10
Value	10	10

Primary outcome: Number of Participants Retained to Study Intervention

Time frame: 3 months after completion of physical therapy.. Count of participants. Unit: Participants

Measure	Control Arm n = 10	Physical Therapy Arm n = 10
Value	10	4

Primary outcome: Adherence to Study Intervention

Time frame: 3 months after completion of physical therapy.. Count of participants. Unit: Participants

Measure	Control Arm n = 10	Physical Therapy Arm n = 4
Value	7	1

Population analysed: Only 4 patients in the physical therapy arm started treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were evaluated at a baseline visit, PT visit (approximately 3 months after randomization), and final visit (approximately 3 months after PT visit). This is a ranged to a maximum of 11 months post randomization.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Arm	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Physical Therapy Arm	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Suzanne K Danhauer, PhD principal investigator

Wake Forest Baptist Comprehensive Cancer Center

Anya Menzies, PhD principal investigator

Wake Forest Baptist Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accrual to Study Intervention (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05242770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.