Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer: Fatigue and Quality of Life During and Waning of Treatment, Psychosocial Aspects (Environment, Work)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- score of fatigue
研究概览
简要总结
Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. Curiously, no study to date has been submitted or published about how women with a one-year treatment "extra" Herceptin ® live this period in terms of quality of life, in terms of psychological impact for themselves and their families.
The investigators have no more data on how often they return to work during this treatment or on the psycho-social parameters which underpin them. It therefore seemed interesting to "give a spotlight" on this particular period in these women HER2 + by comparing a patient population of same age receiving the same adjuvant but with no Herceptin ®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged over 18
- •Invasive breast carcinoma confirmed histologically
- •Non-metastatic cancer
- •Surgery of the primary tumor performed (mastectomy or lumpectomy) and associated with an audit axillary (sentinel node and / or axillary dissection)
- •Patient should receive their last course of adjuvant chemotherapy (3 FEC and 3 Taxotere)
- •Patients not receiving the third course of Taxotere because of toxicities may be included in the fifth course of chemotherapy is the second of Taxotere
- •For the group Herceptin ®: HER2 overexpression without contraindication to treatment administration
- •For the control group: no indication for Herceptin ®
- •Radiation therapy and / or adjuvant hormonal therapy allowed
- •Free and informed consent signed
排除标准
- •Women under 18 or over 60 years
- •Histology other than adenocarcinoma
- •Metastatic Breast Cancer
- •Chemotherapy neoadjuvant
- •Surgery of the primary tumor unrealized
- •Lack of adjuvant chemotherapy with Taxotere 3 FEC and 3
- •Patients with a history of malignancy within 5 years, outside of a basal cell cancer or cancer of the cervix treated and cured
- •Patient under guardianship or unable to give informed consent,
- •Pregnant or lactating
- •Patient unable to undergo a medical for geographical, social or psychopathological
研究组 & 干预措施
patients group with Herceptin
Patients beginning Herceptin in adjuvant after chemotherapy
干预措施: questionnaires (Other)
Control group
patient not beginning Herceptin after chemotherapy : control group
干预措施: questionnaires (Other)
结局指标
主要结局
score of fatigue
时间窗: at 9 months
The main objective of this study is to evaluate the score of fatigue in patients with HER2 overexpressing breast cancer and for whom Herceptin ® treatment is prescribed, compared with a population of patients treated with the same age the same chemotherapy without Herceptin ®.
次要结局
- a qualitative sociological analysis among spouses of patients(at 6 months)
- Assess the quality of life(3, 6, 9 and 12 months)
- quantitative and qualitative psychological impact of Herceptin ®(at 3 months)
- Impact of Herceptin ® in the professional lives(at 3, 6 ,9 and 12 months)