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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04184154
Recruitment Status : Completed
First Posted : December 3, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

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
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.

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Study Type : Observational
Actual Enrollment : 372 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 : April 5, 2017
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : November 8, 2017

Intervention Details:
  • Other: Questionnaires
    The self-questionnaire of 104 questions collected personal and socio-demographics data, global and sexual quality of life characteristics (European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires: QLQ-C30 and gynecologic and cervical cancer specific-questionnaire QLQ-CX24), vaginal dilatators and moisturizers use, and barriers and facilitators of their use. Clinical data were extracted from the patients' medical files. Vaginal stenosis was evaluated at 6 weeks after the end of brachytherapy and after 1-year follow-up by in-town gynecologists or in our Institute, and censored in case of complete vaginal obliteration


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

  2. Clinical characteristics of patients who followed the "Gyn and Co LR" [ Time Frame: 1 day ]
    Quality of life questionnaire: EORTC-QLQ-C30, EORTC QLQ-CX24


Secondary Outcome Measures :
  1. Rate of vaginal dilatators and moisturizers use [ Time Frame: 1 day ]
    Auto questionnaire

  2. Vaginal stenosis prevalence [ Time Frame: 1 day ]
    Clinical data from the patient medical file

  3. Urinary or sexual adverse effects [ Time Frame: 1 day ]
    Clinical data from the patient medical file

  4. Patients' overall and sexual quality of life [ Time Frame: 1 day ]
    Sexual quality of life questionnaire:EORTC QLQ-CX24



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184154


Locations
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France
Institut Régional du Cancer de Montpellier
Montpellier, Occ, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Study Chair: Christine KERR, MD Institut Régional du Cancer de Montpellier
Publications:

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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT04184154    
Other Study ID Numbers: ICM-URC 2017/14
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
cervical and endometrial cancer
brachytherapy
patient education program
sexual quality of life
vaginal stenosis
patient-reported outcomes
Additional relevant MeSH terms:
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Pelvic Neoplasms
Neoplasms by Site
Neoplasms