Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer

Study Overview
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Brief Summary
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The KALICOU 3 study will evaluate the effect of emotional skills of patients and their partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance.

Detailed Description
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All women with breast cancer have to face, at any age, to numerous issues linked to cancer (incertitude, recurrence anxiety...) and to physical and psychosocial side effects of treatments which can degrade their life quality. However, young women (<45 years at diagnostic) have to face specific issues related to their age (early menopause, withdrawal of pregnancy projects, education of young children). Moreover, treatment consequences can alter patient's life quality and can persist in time (fatigue, pains, chemotherapy, sexuality, induced menopause for example). Overall, young patients have a lesser life quality, greater emotional distress and vulnerability and have more difficulties to establish adapted adjustment strategy compared to elder women. The role and importance of relatives, particularly partners, during cancer pathology is incontestable. However, few empiric and consensual data exist on the impact of cancer diagnostic on partners, especially when women are young at initial diagnostic. Nevertheless, available data underline the importance of the supporting partner during breast cancer disease. Cancer also disturbs conjugal relationship. For example, life quality of patient influence strongly the life quality and mental well-being of her partner. Moreover, the intimate relation with the partner could play an important role in healing after breast cancer. Numerous authors underline the importance of focus on the couple instead of patients alone or partners alone with a dyadic approach where dyad member's reactions will be interdependent. Thus, study of dyadic adjustment of couples where a member is facing cancer pathology at young age is indubitably innovative and present a real scientific and clinical interest. More precisely, KALICOU 3 study will focus on the impact of intrapersonal and interpersonal emotional skills of patients and partners on individual and dyadic adjustment.

Official 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

Conditions
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Aging, Breast Cancer

Intervention / Treatment
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* Other: Delivery of questionnaires
* Behavioral: Questionnaire T1 to fill
* Behavioral: Questionnaire T2 to fill
* Behavioral: Questionnaire T3 to fill
* Behavioral: Questionnaire T4 to fill
* Behavioral: Questionnaire T5 to fill


Participation Criteria
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Eligibility 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

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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study procedure<br>Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill | Other: Delivery of questionnaires<br>* After patient and partner information, clinical research associate or clinical research nurse will give to the couple 2 booklets containing 5 questionnaires, respectively T1, T2, T3, T4 and T5.<br>Behavioral: Questionnaire T1 to fill<br>* T1 is to fill before chemotherapy.<br>Behavioral: Questionnaire T2 to fill<br>* T2 is to fill after the 6th cycle of chemotherapy.<br>Behavioral: Questionnaire T3 to fill<br>* T3 is to fill at the end of radiotherapy.<br>Behavioral: Questionnaire T4 to fill<br>* T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy.<br>Behavioral: Questionnaire T5 to fill<br>* T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCI-YW ( Breast Cancer Inventory - Young Women) | To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance | an average of 1 year | 
| BCI-Partner's YW ( Breast Cancer Inventory - Young Women Partner's) | To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance | an average of 1 year | 
| PEC (Profile of Emotional Competences) | To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCI-YW | To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner | an average of 1 year | 
| BCI-Partner's YW | To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner | an average of 1 year | 
| SF 36 (Short Form 36 - Health Survey) | To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner | an average of 1 year | 
| Hospital Anxiety-Depression Scale | To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner | an average of 1 year | 
| Profile of Emotional Competences | To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner | an average of 1 year | 
| MAVA (Measure of affectivity: Valence/Activation) | To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner | an average of 1 year |