Gyn&Co: Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle (Other)

Overall Status

Completed

CT.gov ID

NCT04184154

Collaborator

(none)

167

Enrollment

Location

7.1

Actual Duration (Months)

23.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Cancer Cervical Cancer	Other: Questionnaires

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.

Study Design

Study Type:

Observational

Actual Enrollment :

167 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Vaginal Dilatators and Moisturizers Use and Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.

Actual Study Start Date :

Apr 5, 2017

Actual Primary Completion Date :

Jul 15, 2017

Actual Study Completion Date :

Nov 8, 2017

Outcome Measures

Primary Outcome Measures

Socio-demographics characteristics of patients who followed the "Gyn and Co LR" education program [1 day]
Quality of life questionnaire: EORTC-QLQ-C30, EORTC QLQ-CX24
Clinical characteristics of patients who followed the "Gyn and Co LR" [1 day]
Quality of life questionnaire: EORTC-QLQ-C30, EORTC QLQ-CX24

Secondary Outcome Measures

Rate of vaginal dilatators and moisturizers use [1 day]
Auto questionnaire
Vaginal stenosis prevalence [1 day]
Clinical data from the patient medical file
Urinary or sexual adverse effects [1 day]
Clinical data from the patient medical file
Patients' overall and sexual quality of life [1 day]
Sexual quality of life questionnaire:EORTC QLQ-CX24

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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