Clinical trial NCT04539587: Sexual Quality of Life in Women During the First Year of Adjuvant Hormonal Treatment for Breast Cancer.
Official title: Sexual Quality of Life in Women During the First Year of Adjuvant Hormonal Treatment for Breast Cancer: a Prospective Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Cancer
Quality of Life
Keywords: breast cancer
hormonotherapy
women
quality of life
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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).

A prospective longitudinal assessment is conduted 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.

Eligibility 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.

Primary outcomes:
measure: Sexual quality of life: EORTC SHQ-C22 questionnaire
timeFrame: At the inclusion, at day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
Study officials:
affiliation: Institut Régional du Cancer de Montpellier (ICM)
name: Véronique D'HONDT, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.