Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner

Study Overview
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Brief Summary
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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

Detailed Description
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Before consultation : Selection of patients according to inclusion criteria by persons in charge and preparation of inclusion file 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-demographique questionnaire) They send the documents thanks to stamped envelopes: They send information note to the medical center They send the questionnaires to the university

Official Title
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Psychometric Validation of a Subjective Quality-of-life Scale in Young Women With a Non Metastatic Breast Cancer and Her Partner (KALICOU 2 Protocol)

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >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. Exclusion Criteria: Patient or patner with psychiatric trouble Native language other than french

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pending chemotherapy +/- trastuzumab<br>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 | |
| pending trastazumab +/- hormone therapy<br>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 | |
| pending hormone therapy alone<br>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 | |
| pending afercare period<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychometric validation of a questionnaire in Young patients and their partners |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare convergent and or divergent dimensions with patients and theirs partners |  | 1 year | 
| compare responses of participants according to traitement/ surveillance period |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Quality Of Life, Women, Partner