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

• ClinicalTrials.gov Identifier: NCT04539587
• Recruitment Status: Completed
• First Posted: September 7, 2020
• Last Update Posted: September 7, 2020
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Information provided by (Responsible Party): Institut du Cancer de Montpellier - Val d'Aurelle

Study Description

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.

Condition or disease	Intervention/treatment
Breast Cancer; Cancer; Quality of Life	Other: Quality of life

Detailed Description:

Breast cancer (BC) is the most common cancer in women worldwide, affecting approximately one in eight women during her lifetime in Western countries. (chiffres Globocan). Approximately two thirds of BC are hormone receptor-positive and the multimodal treatment will therefore include hormone therapy during 5 years or even longer (Burstein et al. 2019).

Many studies have described a wide range of disruptions in day to day living after breast cancer diagnosis and treatment. These physical, psychological and social concerns for the patients, related to the disease and its treatment, are now recognized as important outcomes in clinical trials and are evaluated in standardized Health-related quality of life (HRQL) questionnaires like the general EORTC QLQ-C30 dedicated to all cancer patients (Aaronson et al. 1993) or the EORTC QLQ-BR23 dedicated to breast cancer patients (Sprangers et al. 1996).

Sexual dysfunction is frequent during and after treatment for breast cancer (Ananth et al. 2003; Krychman et al. 2006; Pup et al. 2019) and is not specifically evaluated in these general HRQL questionnaires. Recently, the EORTC SHQ-C22 has been developed as a standardized instrument to evaluate sexual quality of life (QoL) in cancer patients to address and evaluate in more detail the sexual dysfunction related to the disease and the treatment(Oberguggenberger et al. 2018).

We conducted a prospective longitudinal assessment of the sexual functioning of women during the first year of adjuvant hormonal therapy using global HRQL questionnaires as well as the new SHQ-C22 questionnaire specifically dedicated to sexual QoL for cancer patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 106 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Sexual Quality of Life in Women During the First Year of Adjuvant Hormonal Treatment for Breast Cancer: a Prospective Longitudinal Study
• Actual Study Start Date: May 2, 2018
• Actual Primary Completion Date: November 30, 2018
• Actual Study Completion Date: October 30, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; The patient will receive the following questionnaires to be completed : EORTC QLQ-C30 EORTC QLQ-BR23 EORTC SHQ-C22

Outcome Measures

Primary Outcome Measures :

1. Sexual quality of life: EORTC SHQ-C22 questionnaire [ Time Frame: At the inclusion, at one time ]
   Sexual quality of life assessed by the EORTC SHQ-C22 questionnaire

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - 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.

Contacts and Locations

Locations

France

Institut régional du Cancer de Montpellier

Montpellier, France, 34298

Sponsors and Collaborators

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

• Study Chair: Véronique D'HONDT, MD; Institut Régional du Cancer de Montpellier (ICM)

More Information

Publications:

Cavalheiro JA, Bittelbrunn A, Menke CH, Biazús 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.

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. Review.

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.

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.

• Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
• ClinicalTrials.gov Identifier: NCT04539587
• Other Study ID Numbers: PROICM 2018-05 BCU
• First Posted: September 7, 2020
• Last Update Posted: September 7, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

breast cancer; hormonotherapy; women; quality of life

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases