Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

Официальное название

Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

Обзор

The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. The aim is to improve the quality of sexual life of these patients.

Подробное описание

Breast cancer and its treatment are responsible for symptoms that can persist over time and affect quality of life. Given the improved prognosis for breast cancer, more and more patients are faced with the specific problems of the post-cancer period, and caring for them has become a major health issue. Sexual health is a crucial component of well-being and overall quality of life.

The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request.

For that, quality of life questionnaires will be completed by patients at inclusion and every 6 months for 2 years.

Вмешательства

• Другое Quality of life questionnaire (QLQ)
  Quality of life questionnaire : EORTC QLQ-C30, EORTC QLQ-Breast cancer module (BR) 23, EORTC SHQ-C22 et HADS at inclusion, visit 1 (6 months +/-1 month before the inclusion), visit 2 (12 months +/-1 month before the inclusion), visit 3 (18 months +/-1 month before the inclusion) and visit 4 (24 months +/-1 month before the inclusion).
• Другое Satisfaction survey
  The satisfaction score will be collected using a visual analog scale from 0 to 10 and the satisfaction questionnaire will also be completed at visit 4 (24 months +/- 1 month before the inclusion).
• Другое Assessment of patient needs in the field of oncosexology
  Assessment of patient needs in the field of oncosexology during a face-to-face or virtual interview at inclusion and every 6 months for 2 years. If a need is identified, an oncosexology consultation will be organised. Following this, a personalised care plan may be proposed.

Первичные конечные точки

• Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm [Срок оценки: at 12 months after the inclusion]

Вторичные конечные точки (8)

• Description of evolution in sexual quality of life [Срок оценки: at inclusion, 6,12,18, and 24 months before inclusion]
• Description of evolution in quality of life - QLQ-C30 [Срок оценки: at inclusion, 6,12,18, and 24 months before inclusion]
• Description of evolution in quality of life - QLQ-Breast (BR)cancer module 23 questionnaires. [Срок оценки: at inclusion, 6,12,18, and 24 months before inclusion]
• Search for associations between comorbidities and risk factors [Срок оценки: at inclusion, 6,12,18, and 24 months before inclusion]
• Search for associations between comorbidities and risk factors -questionnaire [Срок оценки: at inclusion, 6,12,18, and 24 months before inclusion]
• Assessment of adherence to the programme in the interventional arm [Срок оценки: at inclusion]
• Oncosexology programme satisfaction [Срок оценки: at 24 months before inclusion]
• Oncosexology programme satisfaction [Срок оценки: at 24 months before inclusion]

Критерии участия

Критерии включения

• Woman or man at least 18 years old
• Diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor
• Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously
• Patient with sufficient command of the French language to be able to answer the questionnaires
• Patient having given informed, written and express consent.
• Affiliation to the French Social Security System
• Willingness and ability to comply with scheduled visits, treatment plan and other study procedures

Критерии исключения

• Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments)
• Metastatic disease
• Patient under guardianship, curatorship or safeguard of justice

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 9 центров

• Institut de Cancérologie de l'Ouest — Saint-Herblain
• Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy
• Centre Léon Bérard — Lyon
• ICM Val d'Aurelle — Montpellier
• Centre Antoine Lacassagne — Nice
• CHU de Nîmes — Nîmes
• Institut Curie — Paris
• IUCT - Oncopole — Toulouse
• … и ещё 1 центр

Публикации

• Carter J, Lacchetti C, Andersen BL, Barton DL, Bolte S, Damast S, Diefenbach MA, DuHamel K, Florendo J, Ganz PA, Goldfarb S, Hallmeyer S, Kushner DM, Rowland JH. Interventions to Address Sexual Problems in People With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Adaptation of Cancer Care Ontario Guideline. J Clin Oncol. 2018 Feb 10;36(5):492-511. doi: 10.1200/JCO.2017. PMID 29227723
• Bobrie A, Jarlier M, Moussion A, Jacot W, D'Hondt V. Sexual quality of life assessment in young women with breast cancer during adjuvant endocrine therapy and patient-reported supportive measures. Support Care Cancer. 2022 Apr;30(4):3633-3641. doi: 10.1007/s00520-022-06810-3. Epub 2022 Jan 14. PMID 35028721
• Del Pup L, Villa P, Amar ID, Bottoni C, Scambia G. Approach to sexual dysfunction in women with cancer. Int J Gynecol Cancer. 2019 Mar;29(3):630-634. doi: 10.1136/ijgc-2018-000096. Epub 2019 Feb 13. PMID 30765487
• Dizon DS. Quality of life after breast cancer: survivorship and sexuality. Breast J. 2009 Sep-Oct;15(5):500-4. doi: 10.1111/j.1524-4741.2009.00766.x. Epub 2009 Jul 14. PMID 19614908
• Seguin L, Touzani R, Bouhnik AD, Charif AB, Marino P, Bendiane MK, Goncalves A, Gravis G, Mancini J. Deterioration of Sexual Health in Cancer Survivors Five Years after Diagnosis: Data from the French National Prospective VICAN Survey. Cancers (Basel). 2020 Nov 20;12(11):3453. doi: 10.3390/cancers12113453. PMID 33233583

Идентификаторы

NCT: NCT06415266 · PROICM 2023-07 VEN · 2023-A02474-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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