Gynecological CancerNCT03935698
Physiotherapy Treatment in Women With Dyspareunia Following Gynecological Cancer: a Pilot Study
A study testing Physiotherapy in people with Gynecological Cancer and Dyspareunia, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Gynecological cancers represent more than half of female cancers. It has been clearly established that cancer survivors suffer from important health issues such as pain during sexual intercourse (dyspareunia) and sexual dysfunctions which sorely impact their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Cancer, Dyspareunia
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2016to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus)
- Scheduled oncological treatments completed with no signs of cancer for at least 3 months
- Vulvovaginal pain during sexual intercourse for at least 3 months
Who cannot join
- Vulvovaginal pain before cancer and not related to sexual intercourse
- Medication recognized to affect pain
- Refuse to stop other treatments until post-treatment assessment
- Other conditions interfering with assessment
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Physiotherapy Treatment in Gynecological Cancer Survivors Suffering From Dyspareunia: a Mixed-Method Pilot Study
Gynecological cancers represent more than half of female cancers. It has been clearly established that cancer survivors suffer from important health issues such as pain during sexual intercourse (dyspareunia) and sexual dysfunctions which sorely impact their quality of life. Although it affects more than 63% of cancer survivors, the available treatments remain limited and poorly studied. Cancer survivors are thus confronted with these health issues as well as relationship difficulties and psychological consequences, with limited treatment avenues. Addressing pelvic floor muscle dysfunctions and loss of vaginal elasticity, pelvic floor physiotherapy was shown to be effective in reducing or even alleviating dyspareunia and improving sexual function. Until now, no study investigated this treatment in gynecological cancer survivors with dyspareunia. Therefore, there is a need to examine pelvic floor physiotherapy to determine whether or not gynecological cancer survivors with dyspareunia could benefit from this treatment. The objectives of this single-arm mixed-method study are to evaluate the acceptability and feasibility of a physiotherapy treatment in gynecological cancer survivors suffering from dyspareunia and to explore treatment effects. This single-arm study using mixed methods will involve three data collections (pre- and post-treatment assessments). These assessments will be carried out by physiotherapists. Participants will receive physiotherapy treatment weekly in individual 60-minute sessions for 12 weeks. Thirty-one gynecological cancer survivors with vulvovaginal pain during sexual intercourse for at least 3 months will be recruited. The results of this study will bring new information regarding physiotherapy treatment for this population in preparation for a definitive randomized controlled trial.
- Conditions
- Gynecological Cancer, Dyspareunia
- Being tested
- Physiotherapy
- Keywords
- Pilot study, Feasibility study, Dyspareunia, Gynecological cancer survivors, Physiotherapy
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Also called Pelvic floor rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Experimental | 12 weekly 60-minute individual sessions of multimodal physiotherapy including education, stretching techniques, pelvic floor muscle biofeedback as well as home exercises. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rates
To determine acceptability.
Measured: Pre- to 2-week post-treatment assessment
Retention rate
To determine feasibility.
Measured: Pre- to 2-week post-treatment assessment
Secondary outcomes (6)
Change from baseline in pain
To explore changes in pain during sexual intercourse (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever).
Measured: Pre- to 2-week post-treatment assessment
Change from baseline in sexual function
To explore changes in sexual function (Female Sexual Function Index).
Measured: Pre- to 2-week post-treatment assessment
Change from baseline in pelvic floor muscle function
To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry and ultrasound).
Measured: Pre- to 2-week post-treatment assessment
Change from baseline in quality of life
To explore changes in quality of life (questionnaire).
Measured: Pre- to 2-week post-treatment assessment
Patient's global impression of change
To determine patient self-reported improvement (Patient's Global Impression of Change).
Measured: 2-week post-treatment assessment
Adverse events
To document any adverse events.
Measured: Pre- to 2-week post-treatment assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start8 Sep 2016
- Primary completion31 Dec 2020
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecological CancerStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-treatment assessment - Intervention (12 weeks) - Post-treatment assessment
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Institut Universitaire de Gériatrie de Montréal, Jewish General Hospital, Centre hospitalier de l'Université de Montréal (CHUM)
- Responsible party
- Principal investigator, Mélanie Morin, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935698
- Sponsor's protocol ID
- MP-31-2016-1322
- Status last verified
- Jan 2022
- First submitted
- 10 Apr 2019
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cyr MP, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Changes in pelvic floor morphometry and muscle function after multimodal physiotherapy for gynaecological cancer survivors suffering from dyspareunia: a prospective interventional study. Physiotherapy. 2022 Mar;114:54-62. doi: 10.1016/j.physio.2021.09.003. Epub 2021 Sep 30.
PubMed 35093737
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Treatment in Gynecological Cancer Survivors Suffering From Dyspareunia: a Mixed-Method Pilot Study
- ClinicalTrials.gov ID
- NCT03935698
- Acronym / sponsor ID
- MP-31-2016-1322
- Conditions
- Gynecological Cancer, Dyspareunia
- Keywords
- Pilot study, Feasibility study, Dyspareunia, Gynecological cancer survivors, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Institut Universitaire de Gériatrie de Montréal, Jewish General Hospital, Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- 8 Sep 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gynecological cancers represent more than half of female cancers. It has been clearly established that cancer survivors suffer from important health issues such as pain during sexual intercourse (dyspareunia) and sexual dysfunctions which sorely impact their quality of life. Although it affects more than 63% of cancer survivors, the available treatments remain limited and poorly studied. Cancer survivors are thus confronted with these health issues as well as relationship difficulties and psychological consequences, with limited treatment avenues. Addressing pelvic floor muscle dysfunctions and loss of vaginal elasticity, pelvic floor physiotherapy was shown to be effective in reducing or even alleviating dyspareunia and improving sexual function. Until now, no study investigated this treatment in gynecological cancer survivors with dyspareunia. Therefore, there is a need to examine pelvic floor physiotherapy to determine whether or not gynecological cancer survivors with dyspareunia could benefit from this treatment. The objectives of this single-arm mixed-method study are to evaluate the acceptability and feasibility of a physiotherapy treatment in gynecological cancer survivors suffering from dyspareunia and to explore treatment effects. This single-arm study using mixed methods will involve three data collections (pre- and post-treatment assessments). These assessments will be carried out by physiotherapists. Participants will receive physiotherapy treatment weekly in individual 60-minute sessions for 12 weeks. Thirty-one gynecological cancer survivors with vulvovaginal pain during sexual intercourse for at least 3 months will be recruited. The results of this study will bring new information regarding physiotherapy treatment for this population in preparation for a definitive randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-treatment assessment - Intervention (12 weeks) - Post-treatment assessment
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Experimental | Other: Physiotherapy12 weekly 60-minute individual sessions of multimodal physiotherapy including education, stretching techniques, pelvic floor muscle biofeedback as well as home exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus)
- Scheduled oncological treatments completed with no signs of cancer for at least 3 months
- Vulvovaginal pain during sexual intercourse for at least 3 months
Key exclusion criteria (4 listed)
- Vulvovaginal pain before cancer and not related to sexual intercourse
- Medication recognized to affect pain
- Refuse to stop other treatments until post-treatment assessment
- Other conditions interfering with assessment
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 |
|---|---|---|
| PhysiotherapyAlso: Pelvic floor rehabilitation | Other | Physiotherapy |
Primary outcome
Adherence rates
Time frame: Pre- to 2-week post-treatment assessment
To determine acceptability.
Retention rate
Time frame: Pre- to 2-week post-treatment assessment
To determine feasibility.
6 secondary outcomes
Change from baseline in pain
Time frame: Pre- to 2-week post-treatment assessment
Change from baseline in sexual function
Time frame: Pre- to 2-week post-treatment assessment
Change from baseline in pelvic floor muscle function
Time frame: Pre- to 2-week post-treatment assessment
Change from baseline in quality of life
Time frame: Pre- to 2-week post-treatment assessment
Patient's global impression of change
Time frame: 2-week post-treatment assessment
Adverse events
Time frame: Pre- to 2-week post-treatment assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 35093737Cyr MP, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Changes in pelvic floor morphometry and muscle function after multimodal physiotherapy for gynaecological cancer survivors suffering from dyspareunia: a prospective interventional study. Physiotherapy. 2022 Mar;114:54-62. doi: 10.1016/j.physio.2021.09.003. Epub 2021 Sep 30.
- Individual participant dataSharing planned: No
Related trials for Gynecological Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingPhase 1/2
A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)
Tumours, Gynecological
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
RecruitingObservational study
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Gynaecological Cancers
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Gynecological Cancer and Dyspareunia, run by Université de Sherbrooke at 1 site in Canada.
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 3 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 27 Jan 2022. 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 Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence rates (time frame: Pre- to 2-week post-treatment assessment). The study lists 2 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 NCT03935698, which also lists 1 linked publication.
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 27 Jan 2022.