Psychometric Validation of a Subjective Quality-of-life Scale in Young Women With a Non Metastatic Breast Cancer and Her Partner (KALICOU 2 Protocol)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,045
- 试验地点
- 25
- 主要终点
- Psychometric validation of a questionnaire in Young patients and their partners
研究概览
简要总结
- Selection of patient and preparation of questionnaires
- Presentation of the study by the doctor
- Verbal consent of participants (patient and Partner)
- Delivery of booklets
- Response to documents (questionnaires and written consent) at home, send by mail
详细描述
- Before consultation :
Selection of patients according to inclusion criteria by persons in charge and preparation of inclusion file 2. During the consultation :
- Presentation of the study by the investigator
- The investigator signs the information note and give two file to the patient (1 for her and 1 for her Partner : both contains 1 information note signed by the investigator, 1 questionnaire and 2 stamped envelopes
- Finally, the investigator fill-in the medical form and send the original to the university (université de Lille 3)
- At home :
- Signature of the information note and the participation consent form
- Patients and Partner responds to their questionnaire (including socio-demographic questionnaire)
- They send the documents thanks to stamped envelopes:
- They send information note to the medical center
- They send the questionnaires to the university
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old (patient and partner)
- •<45 years old (patient)
- •Patient with a non metastatic breast cancer
- •Patient treated or previously treated by chemotherapy
- •Patient and her Partner live together for at least 6 months when they complete the questionnaires.
排除标准
- •Patient or partner with psychiatric trouble
- •Native language other than french
研究组 & 干预措施
Pending chemotherapy +/- trastuzumab
In the 1st group (chemotherapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Pending trastuzumab +/- hormone therapy
In the 2nd group (trastuzumab), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Pending hormone therapy alone
In the third group (hormone therapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Pending aftercare period
In the last group (aftercare), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
结局指标
主要结局
Psychometric validation of a questionnaire in Young patients and their partners
时间窗: 1 year
次要结局
- Compare convergent and or divergent dimensions with patients and theirs partners(1 year)
- Compare responses of participants according to treatment/ surveillance period(1 year)