Sexual Quality of Life in Women During the First Year of Adjuvant Hormonal Treatment for Breast Cancer.

NCT04539587 | Completed

• 1 other identifier: PROICM 2018-05 BCU
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common cancer in women worldwide. Hormonal therapy is one of the major treatments for hormone receptor positive breast tumors. It is prescribed to 70% of breast cancer patients. Hormonal therapy can be responsible for sexual dysfunction induced by hormonal changes. Extended adjuvant hormonal therapy over 5 years increases these adverse effects. According to the third "Plan Cancer" (2014-2019), sexual dysfunction prevention and screening must be systematic as an integral part of supportive care. Nevertheless, sexual quality of life remains too rarely considered. In this study, the investigator propose to evaluate sexual quality of life of women less than 51 years old during the adjuvant endocrine therapy for localized breast cancer. The investigator also intend to collect the supportive measures or interventions used by women to overcome sexual dysfunction. Finally, this study aims to evaluate the need for sexual trouble specific management and acceptability of different methods. This project is a hot topic as the interest for oncosexuality is growing, and the need for specific management is increasing with still insufficient access to specific care.

Conditions

Breast Cancer; Cancer; Quality of Life

Keywords

breast cancer; hormonotherapy; women; quality of life

Outcome Measures

Primary Outcomes (1)

• Sexual quality of life: EORTC SHQ-C22 questionnaire

  Sexual quality of life assessed by the EORTC SHQ-C22 questionnaire

  At the inclusion, at day 1

Study Arms (1)

adjuvant hormonal therapy for breast cancer

Women more than 18 years old, with hormone receptor-positive early BC, with completed surgery as well as chemotherapy and/or radiotherapy, if indicated, and had begun their hormonal therapy for less than 6 months.

Other: Quality of life

Interventions

Quality of life OTHER

The patient will receive the following questionnaires to be completed : EORTC QLQ-C30 EORTC QLQ-BR23 EORTC SHQ-C22

adjuvant hormonal therapy for breast cancer

Eligibility Criteria

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

Study Population

Eligible patients were minimum 18 years old, had hormone receptor-positive early BC, had all completed surgery as well as chemotherapy and/or radiotherapy, if indicated, and had begun their hormonal therapy for less than 6 months.

You may qualify if:

• Female age ≥ 18 years old
• Patient with non-metastatic early breast cancer,
• Patient undergoing adjuvant hormonal therapy
• Patient who has been treated by surgery, with or without chemotherapy and/or radiotherapy.
• Patient being currently sexually active.
• Patient who agreed, after receiving information, to participate to the study.

You may not qualify if:

• \- Patient who refused to participate to this study or is unable to fulfill a questionnaire,
• Patient not affiliated to the French social security system,
• Subject under tutelage, curatorship or safeguard of justice,
• Patient in an emergency situation,
• Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,
• Pregnant and / or breastfeeding woman.

Sponsors & Collaborators

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

Study Sites (1)

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (4)

• Cavalheiro JA, Bittelbrunn A, Menke CH, Biazus JV, Xavier NL, Cericatto R, Schuh F, Pinheiro CV, Passos EP. Sexual function and chemotherapy in postmenopausal women with breast cancer. BMC Womens Health. 2012 Sep 11;12:28. doi: 10.1186/1472-6874-12-28.

  PMID: 22963155 BACKGROUND

• Dow J, Kennedy Sheldon L. Breast Cancer Survivors and Sexuality: A Review of the Literature Concerning Sexual Functioning, Assessment Tools, and Evidence-Based Interventions. Clin J Oncol Nurs. 2015 Aug;19(4):456-61. doi: 10.1188/15.CJON.456-461.

  PMID: 26207711 BACKGROUND

• Frechette D, Paquet L, Verma S, Clemons M, Wheatley-Price P, Gertler SZ, Song X, Graham N, Dent S. The impact of endocrine therapy on sexual dysfunction in postmenopausal women with early stage breast cancer: encouraging results from a prospective study. Breast Cancer Res Treat. 2013 Aug;141(1):111-7. doi: 10.1007/s10549-013-2659-y. Epub 2013 Aug 14.

  PMID: 23942873 BACKGROUND

• Hummel SB, van Lankveld JJDM, Oldenburg HSA, Hahn DEE, Kieffer JM, Gerritsma MA, Kuenen MA, Bijker N, Borgstein PJ, Heuff G, Lopes Cardozo AMF, Plaisier PW, Rijna H, van der Meij S, van Dulken EJ, Vrouenraets BC, Broomans E, Aaronson NK. Efficacy of Internet-Based Cognitive Behavioral Therapy in Improving Sexual Functioning of Breast Cancer Survivors: Results of a Randomized Controlled Trial. J Clin Oncol. 2017 Apr 20;35(12):1328-1340. doi: 10.1200/JCO.2016.69.6021. Epub 2017 Feb 27.

  PMID: 28240966 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Véronique D'HONDT, MD

  Institut Régional du Cancer de Montpellier (ICM)

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: May 2, 2018
• Primary Completion: November 30, 2018
• Study Completion: October 30, 2019
• Last Updated: February 13, 2025

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)