Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner
NCT ID: NCT02858063
Last Updated: 2016-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1045 participants
OBSERVATIONAL
2010-01-31
2012-07-31
Brief Summary
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* 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
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Detailed Description
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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)
3. At home :
* Signature of the information note and the participation consent form
* Patients and Partner responds to their questionnaire (including socio-demographique questionnaire)
* They send the documents thanks to stamped envelopes:
1. They send information note to the medical center
2. They send the questionnaires to the university
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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 ansmwer twice to KALI questionnaire, with a delay of 15 days between each other
No interventions assigned to this group
pending trastazumab +/- hormone therapy
In the 2nd group (trastazumab), 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 ansmwer twice to KALI questionnaire, with a delay of 15 days between each other
No interventions assigned to this group
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 ansmwer twice to KALI questionnaire, with a delay of 15 days between each other
No interventions assigned to this group
pending afercare 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 ansmwer twice to KALI questionnaire, with a delay of 15 days between each other
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* \<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.
Exclusion Criteria
* Native language other than french
18 Years
45 Years
ALL
No
Sponsors
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Université Lille 3
UNKNOWN
Centre Oscar Lambret
OTHER
Responsible Party
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Other Identifiers
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KALICOU2-0909
Identifier Type: -
Identifier Source: org_study_id
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