Clinical trial · Observational
Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner
Psychometric Validation of a Subjective Quality-of-life Scale in Young Women With a Non Metastatic Breast Cancer and Her Partner (KALICOU 2 Protocol)
NCT02858063CI-TRIAL-00105598KALICOU2completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- 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 answer twice to KALI questionnaire, with a delay of 15 days between each other
- label
- Pending trastuzumab +/- hormone therapy
- description
- 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
- label
- 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 answer twice to KALI questionnaire, with a delay of 15 days between each other
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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 partner with psychiatric trouble * Native language other than french
References
Publications (0)
Data not yet available
No reference posted for this study.