Programme d'Éducation Thérapeutique et d'Accompagnement Infirmier Vers Les Soins de Support, Chez Les Patientes Sous Hormonothérapie Pour un Cancer du Sein Non métastatique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- To compare the effectiveness of adding a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone on the management of adverse events related to adjuvant hormone therapy.
研究概览
简要总结
To compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (AEs) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.
详细描述
The main objective of the ETAPH project is to offer breast cancer patients multidisciplinary care that will limit the impact of adverse effects related to hormone therapy treatment and improve their quality of life. The achievement of this objective is based on therapeutic education and nursing follow-up throughout the first year of treatment, which, thanks to active listening and coordination of the various players, will enable global and personalized patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 75 years inclusive
- •Patients with non-metastatic breast cancer for whom adjuvant hormone therapy (anti-oestrogen or anti-aromatase) is indicated, depending on the decision of the multidisciplinary consultation meeting.
- •Performance status (ECOG) ≤ 2
- •Patient able to read and understand French (common use)
- •Patient with access to an internet connection (for collection of adverse events and responses to questionnaires on the electronic platform)
- •Patient who has been informed and has given written consent to participate in the study
- •Patient affiliated to the French social security system or equivalent
排除标准
- •Patient with metastatic cancer (stage IV)
- •Patient undergoing neoadjuvant hormone therapy
- •Patient who started hormone therapy prior to inclusion in the study
- •Patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago.
- •For patients in the experimental group: Inability of the patient to travel to the hospital to attend the initial assessment day and the proposed group outpatient workshops; follow-up of the program difficult for geographical, physical or other reasons (at the discretion of the investigator).
- •For patients in the control group: patients for whom telephone nursing follow-up is planned for 2 months or more or more than 4 sessions of therapeutic education.
- •Pregnant and breastfeeding women
- •Patient with a documented history of cognitive or psychiatric disorders
- •Refusal to participate, protected adult patient, under guardianship or curatorship
研究组 & 干预措施
Control group
Patients will have the conventional oncology follow-up.
Experimental group with the therapeutic education and nursing support program
In addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day.
干预措施: Therapeutic Education and Nursing Support Program for Supportive Care (Other)
结局指标
主要结局
To compare the effectiveness of adding a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone on the management of adverse events related to adjuvant hormone therapy.
时间窗: For a year
The primary endpoint is the score of the 7 adverse events (AEs), graded on a Likert scale from 0 to 4 points from the NCI-CTCAE v5.0, which will be transformed into a single composite endpoint. The 7 AEs considered here will be the most frequent and troublesome of the hormone therapy, namely: muscle and/or joint pain, hot flashes, headache, fatigue, insomnia/sleep disturbance, weight gain, nausea. This collection will be done initially (T0) and then monthly by the patients.
次要结局
- To compare the effectiveness of adding the program to conventional management alone in terms of drug use for the management of adverse events throughout the study.(From date of first Hormone Therapy intake to 12 months)
- To compare the effectiveness of adding the program to conventional management alone in terms of patients' level of knowledge about the disease and treatment.(Change from baseline at Month 2)
- To describe the non-drug means used by patients to manage their adverse events and their use of supportive care during the study.(For a year)
- To compare the effectiveness of adding the program to conventional management alone in terms of therapeutic compliance at Month 6 and Month 12.(Change from Month 6 and Month 12)
- To compare the effectiveness of adding the program to conventional management alone in terms of patients' confidence regarding the use of hormone therapy at Day 0, Month 6 and Month 12.(Change from baseline at Month 6 and Month 12)
- To compare the effectiveness of adding the program to conventional management alone in terms of patients' satisfaction with their care at Month 12.(For a year)
- To compare the effectiveness of adding the program to conventional management alone in terms of medico-economic impact of the program, in terms of cost-utility.(For a year)
- To assess patient interest in and adherence to the proposed program in the experimental group.(For a year)
- To compare the effectiveness of adding the program to conventional management alone in terms of sleep quality at baseline (Day 0), Month 6 and Month 12.(Change from baseline at Month 6 and Month 12)
- To compare the effectiveness of adding the program to conventional management alone in terms of quality of life for patients on hormone therapy at baseline (Day 0), Month 6 and Month 12.(Change from baseline at Month 6 and Month 12)