Clinical trial NCT04184154: Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.
Official title: Vaginal Dilatators and Moisturizers Use and Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Cancer
Cervical Cancer
Keywords: cervical and endometrial cancer
brachytherapy
patient education program
sexual quality of life
vaginal stenosis
patient-reported outcomes
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 167
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of the study is composed of all patients who followed the ETP curietherapy program between January 2014 and December 2015; this potentially represents372 patients.

Brief summary: Gynecologic cancer treatments (chemoradiotherapy, brachytherapy and surgery) greatly impact patients' sexual quality of life (QoL). Use of the vaginal dilators may reduce vaginal stenosis. Since 2011, our "Gyn and Co LR" patient education program aims to optimize early care of sexual disorders following treatment of cervical and endometrial cancer.

Detailed description: Pelvic cancer accounts for 38,000 cancer cases in France; among them, 15,500 are gynecologic, i.e. endometrial, ovarian, cervical, vaginal and vulval. In 2017, 8,367 new endometrial cancer cases were reported in France1. Endometrial cancer mostly affects women who already underwent menopause; indeed, the median age at diagnosis is 68 years. Cervical cancer is less frequent, with 2,835 new cases reported in France in 2017, but affects younger women. The incidence peak is reported at 40 years, with a median age at death of around 50 years.

The standard of care for cervical cancer combines chemoradiotherapy with utero-vaginal brachytherapy, followed or not with surgery. For endometrial cancer, post-operative vaginal brachytherapy is recommended for intermediate-risk tumors or following radiotherapy for high-risk patients. However, in both cancer localizations, the combination of external radiation and brachytherapy induces numerous adverse effects affecting the patients' overall and sexual quality of life. Digestive, urinary and sexual disorders reported include abdominal pain, incontinence, cystitis, dyspareunia, vaginal irritation, pain during intercourse. A major adverse effect reported is reduction of vaginal elasticity together with vaginal shrinking (shorter and tighter vagina), up to vaginal stenosis. The EMBRACE study showed in 630 patients with locally-advanced cervical cancer a grade ≥ 2 vaginal stenosis rate of 21% at 2 years. A study reported that among sexually active women, 54% were not satisfied or little satisfied with their sexual activity; about 50% women also reported vaginal dryness and more than 40% pain during penetration. The EMBRACE study reported in locally-advanced cervical cancer patients the persistence of treatment-related symptoms, diarrhea, menopausal symptoms, peripheral neuropathy and sexual functioning problems two years after diagnosis. Vaginal dryness, hot flashes and pain at penetration were reported up to 5 to 10 years after diagnosis in cancer survivors as compared with controls in a case-control study. In endometrial cancer patients, a long-term analysis of the PORTEC-2 study reported vaginal dryness, short or narrow vagina and pain during intercourse at 7 years after treatment.

Studies in psycho-oncology or nursing care have assessed the impact of these disorders and are bringing up some solutions, among which use of vaginal dilators to prevent vaginal stenosis and improve sexual quality of life. International guidelines were issued on the use of vaginal dilators by these patients. Both guidelines and studies assessing patient education interventions to increase the patients' use of the vaginal dilators concluded on the possible benefit of educational programs stenosis prevention. Some programs well integrated in the patients' care pathway have been published. Early interventions starting as soon as the disease announcement consult with the radiation oncologist are still needed to improve vaginal stenosis prevention and the patients' sexual quality of life.

In this context, the investigator have initiated, for the first time in France, the "Gyn and Co LR" patient education program, approved by the Regional Health Agency. This program, fully integrated in the patients' care pathway, aimed to optimize an early care of sexual disorders and prevent vaginal stenosis in patients treated with brachytherapy for cervical or endometrial cancer.

Eligibility criteria: Inclusion Criteria:

* Patient with cervical or endometrial cancer, stage I to III who received brachytherapy at the ICM between January 2014 and December 2015.
* Age ≥ 18 years
* Patient who agreed to follow an therapeutic education program during the brachytherapy treatment
* Patient who agreed, after receiving information, to participate to the study

Exclusion Criteria:

* Patient who refused to follow the therapeutic education care program

Primary outcomes:
measure: Socio-demographics characteristics of patients who followed the "Gyn and Co LR" education program
timeFrame: 1 day
measure: Clinical characteristics of patients who followed the "Gyn and Co LR"
timeFrame: 1 day
Secondary outcomes:
measure: Rate of vaginal dilatators and moisturizers use
timeFrame: 1 day
measure: Vaginal stenosis prevalence
timeFrame: 1 day
measure: Urinary or sexual adverse effects
timeFrame: 1 day
measure: Patients' overall and sexual quality of life
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier
state: Occ
Study officials:
affiliation: Institut Régional du Cancer de Montpellier
name: Christine KERR, MD
role: STUDY_CHAIR
References:
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