Dyspareunia, Gynecological Cancer
Conditions
Keywords
Pilot study, Feasibility study, Dyspareunia, Gynecological cancer survivors, Physiotherapy
Brief 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. 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.
Interventions
OTHERPhysiotherapy
Sponsors
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)
Université de Sherbrooke
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pre-treatment assessment - Intervention (12 weeks) - Post-treatment assessment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence rates | Pre- to 2-week post-treatment assessment | To determine acceptability. |
| Retention rate | Pre- to 2-week post-treatment assessment | To determine feasibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pelvic floor muscle function | Pre- to 2-week post-treatment assessment | To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry and ultrasound). |
| Change from baseline in quality of life | Pre- to 2-week post-treatment assessment | To explore changes in quality of life (questionnaire). |
| Change from baseline in pain | Pre- to 2-week post-treatment assessment | 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). |
| Adverse events | Pre- to 2-week post-treatment assessment | To document any adverse events. |
| Patient's global impression of change | 2-week post-treatment assessment | To determine patient self-reported improvement (Patient's Global Impression of Change). |
| Change from baseline in sexual function | Pre- to 2-week post-treatment assessment | To explore changes in sexual function (Female Sexual Function Index). |
Countries
Canada
Outcome results
None listed