Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner (KALICOU2)

Centre Oscar Lambret

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02858063

KALICOU2-0909

Details and patient eligibility

About

• 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

Full description

1. 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)

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

Enrollment: 1,045 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,045 participants in 4 patient groups

Pending chemotherapy +/- trastuzumab

Description:

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

Description:

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

Description:

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

Description:

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