Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.

NCT04184154 | Completed

• 1 other identifier: ICM-URC 2017/14
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Cancer; Cervical Cancer

Keywords

cervical and endometrial cancer; brachytherapy; patient education program; sexual quality of life; vaginal stenosis; patient-reported outcomes

Outcome Measures

Primary Outcomes (2)

• Socio-demographics characteristics of patients who followed the "Gyn and Co LR" education program

  Quality of life questionnaire: EORTC-QLQ-C30, EORTC QLQ-CX24

  1 day

• Clinical characteristics of patients who followed the "Gyn and Co LR"

  Quality of life questionnaire: EORTC-QLQ-C30, EORTC QLQ-CX24

  1 day

Secondary Outcomes (4)

• Rate of vaginal dilatators and moisturizers use

  1 day

• Vaginal stenosis prevalence

  1 day

• Urinary or sexual adverse effects

  1 day

• Patients' overall and sexual quality of life

  1 day

Interventions

Questionnaires OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient who refused to follow the therapeutic education care program

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut Régional du Cancer de Montpellier

Montpellier, Occ, 34298, France

Location

Related Publications (14)

• Potter R, Tanderup K, Kirisits C, de Leeuw A, Kirchheiner K, Nout R, Tan LT, Haie-Meder C, Mahantshetty U, Segedin B, Hoskin P, Bruheim K, Rai B, Huang F, Van Limbergen E, Schmid M, Nesvacil N, Sturdza A, Fokdal L, Jensen NBK, Georg D, Assenholt M, Seppenwoolde Y, Nomden C, Fortin I, Chopra S, van der Heide U, Rumpold T, Lindegaard JC, Jurgenliemk-Schulz I; EMBRACE Collaborative Group. The EMBRACE II study: The outcome and prospect of two decades of evolution within the GEC-ESTRO GYN working group and the EMBRACE studies. Clin Transl Radiat Oncol. 2018 Jan 11;9:48-60. doi: 10.1016/j.ctro.2018.01.001. eCollection 2018 Feb.

  PMID: 29594251 BACKGROUND

• Colombo N, Creutzberg C, Amant F, Bosse T, Gonzalez-Martin A, Ledermann J, Marth C, Nout R, Querleu D, Mirza MR, Sessa C; ESMO-ESGO-ESTRO Endometrial Consensus Conference Working Group. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: Diagnosis, Treatment and Follow-up. Int J Gynecol Cancer. 2016 Jan;26(1):2-30. doi: 10.1097/IGC.0000000000000609.

  PMID: 26645990 BACKGROUND

• Shisler R, Sinnott JA, Wang V, Hebert C, Salani R, Felix AS. Life after endometrial cancer: A systematic review of patient-reported outcomes. Gynecol Oncol. 2018 Feb;148(2):403-413. doi: 10.1016/j.ygyno.2017.11.007. Epub 2017 Nov 14.

  PMID: 29150143 BACKGROUND

• Pfaendler KS, Wenzel L, Mechanic MB, Penner KR. Cervical cancer survivorship: long-term quality of life and social support. Clin Ther. 2015 Jan 1;37(1):39-48. doi: 10.1016/j.clinthera.2014.11.013.

  PMID: 25592090 BACKGROUND

• Zomkowski K, Toryi AM, Sacomori C, Dias M, Sperandio FF. Sexual function and quality of life in gynecological cancer pre- and post-short-term brachytherapy: a prospective study. Arch Gynecol Obstet. 2016 Oct;294(4):833-40. doi: 10.1007/s00404-016-4099-5. Epub 2016 Apr 27.

  PMID: 27117556 BACKGROUND

• Greimel ER, Winter R, Kapp KS, Haas J. Quality of life and sexual functioning after cervical cancer treatment: a long-term follow-up study. Psychooncology. 2009 May;18(5):476-82. doi: 10.1002/pon.1426.

  PMID: 18702067 BACKGROUND

• Huffman LB, Hartenbach EM, Carter J, Rash JK, Kushner DM. Maintaining sexual health throughout gynecologic cancer survivorship: A comprehensive review and clinical guide. Gynecol Oncol. 2016 Feb;140(2):359-68. doi: 10.1016/j.ygyno.2015.11.010. Epub 2015 Nov 7.

  PMID: 26556768 BACKGROUND

• Wilmoth MC. Sexuality: a critical component of quality of life in chronic disease. Nurs Clin North Am. 2007 Dec;42(4):507-14; v. doi: 10.1016/j.cnur.2007.08.008.

  PMID: 17996752 BACKGROUND

• Bergmark K, Avall-Lundqvist E, Dickman PW, Henningsohn L, Steineck G. Vaginal changes and sexuality in women with a history of cervical cancer. N Engl J Med. 1999 May 6;340(18):1383-9. doi: 10.1056/NEJM199905063401802.

  PMID: 10228188 BACKGROUND

• Bruner DW, Lanciano R, Keegan M, Corn B, Martin E, Hanks GE. Vaginal stenosis and sexual function following intracavitary radiation for the treatment of cervical and endometrial carcinoma. Int J Radiat Oncol Biol Phys. 1993 Nov 15;27(4):825-30. doi: 10.1016/0360-3016(93)90455-5.

  PMID: 8244811 BACKGROUND

• Brand AH, Bull CA, Cakir B. Vaginal stenosis in patients treated with radiotherapy for carcinoma of the cervix. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):288-93. doi: 10.1111/j.1525-1438.2006.00348.x.

  PMID: 16445647 BACKGROUND

• Hofsjo A, Bergmark K, Blomgren B, Jahren H, Bohm-Starke N. Radiotherapy for cervical cancer - impact on the vaginal epithelium and sexual function. Acta Oncol. 2018 Mar;57(3):338-345. doi: 10.1080/0284186X.2017.1400684. Epub 2017 Nov 15.

  PMID: 29140150 BACKGROUND

• Kirchheiner K, Nout RA, Lindegaard JC, Haie-Meder C, Mahantshetty U, Segedin B, Jurgenliemk-Schulz IM, Hoskin PJ, Rai B, Dorr W, Kirisits C, Bentzen SM, Potter R, Tanderup K; EMBRACE Collaborative Group. Dose-effect relationship and risk factors for vaginal stenosis after definitive radio(chemo)therapy with image-guided brachytherapy for locally advanced cervical cancer in the EMBRACE study. Radiother Oncol. 2016 Jan;118(1):160-6. doi: 10.1016/j.radonc.2015.12.025. Epub 2016 Jan 9.

  PMID: 26780997 BACKGROUND

• Sekse RJ, Hufthammer KO, Vika ME. Sexual activity and functioning in women treated for gynaecological cancers. J Clin Nurs. 2017 Feb;26(3-4):400-410. doi: 10.1111/jocn.13407. Epub 2016 Jun 23.

  PMID: 27239803 BACKGROUND

MeSH Terms

Conditions

Pelvic Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christine KERR, MD

  Institut Régional du Cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 3, 2019
• Study Start: April 5, 2017
• Primary Completion: July 15, 2017
• Study Completion: November 8, 2017
• Last Updated: November 4, 2021

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)