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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02861742 |
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Date of registration:
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29/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer
KALICOU3 |
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Scientific title:
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Evaluation of the Impact of Emotional Skills of Young Women (= 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer |
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Date of first enrolment:
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July 25, 2016 |
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Target sample size:
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800 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02861742 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Decoupigny Emilie |
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Address:
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Telephone:
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+33 (0) 3 20 29 59 18 |
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Email:
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e-decoupigny@o-lambret.fr |
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Affiliation:
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Name:
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VANLEMMENS Laurence, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oscar Lambret |
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Name:
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Christophe Véronique, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Université Lille 3 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient and partner = 18 years.
- Patient = 45 years at diagnostic of non metastatic breast cancer.
- Disease relevant for neoadjuvant or adjuvant chemotherapy following or not by
radiotherapy or hormonotherapy.
- Heterosexual or homosexual couples in a relationship since at least 6 months at the
date of inclusion
- Patient affiliate to french social welfare system
- Informed consent sign by patient and partner before any study procedure
Exclusion Criteria:
- Psychological or physical inability to fill questionnaire
- Patient under guardianship
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Aging
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Intervention(s)
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Behavioral: Questionnaire T4 to fill
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Behavioral: Questionnaire T3 to fill
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Other: Delivery of questionnaires
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Behavioral: Questionnaire T1 to fill
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Behavioral: Questionnaire T2 to fill
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Behavioral: Questionnaire T5 to fill
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Primary Outcome(s)
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BCI-Partner's YW ( Breast Cancer Inventory - Young Women Partner's)
[Time Frame: an average of 1 year]
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BCI-YW ( Breast Cancer Inventory - Young Women)
[Time Frame: an average of 1 year]
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PEC (Profile of Emotional Competences)
[Time Frame: an average of 1 year]
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Secondary Outcome(s)
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Hospital Anxiety-Depression Scale
[Time Frame: an average of 1 year]
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BCI-YW
[Time Frame: an average of 1 year]
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MAVA (Measure of affectivity: Valence/Activation)
[Time Frame: an average of 1 year]
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Profile of Emotional Competences
[Time Frame: an average of 1 year]
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SF 36 (Short Form 36 - Health Survey)
[Time Frame: an average of 1 year]
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BCI-Partner's YW
[Time Frame: an average of 1 year]
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Secondary ID(s)
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2015-A01808-41
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KALICOU 3-1509
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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