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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01808-41 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| University Charles-de-Gaulle | OTHER |
| Aix Marseille Université | OTHER |
| University of Paris 5 - Rene Descartes | OTHER |
| SIRIC ONCOLille |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study procedure | Other | Delivery of questionnaires, Questionnaire T1 to fill, Questionnaire T2 to fill, Questionnaire T3 to fill, Questionnaire T4 to fill, Questionnaire T5 to fill |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delivery of questionnaires | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurence VANLEMMENS, MD | Oscar Lambret | Principal Investigator |
| Véronique CHRISTOPHE, PhD | University Charles-de-Gaulle | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO-Site Paul Papin | Angers | 49055 | France | |||
| Centre Marie Curie |
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| UNKNOWN |
| Canceropôle Nord Ouest | OTHER |
| National Cancer Institute, France | OTHER_GOV |
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| Questionnaire T1 to fill | Behavioral | T1 is to fill before chemotherapy. |
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| Questionnaire T2 to fill | Behavioral | T2 is to fill after the 6th cycle of chemotherapy. |
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| Questionnaire T3 to fill | Behavioral | T3 is to fill at the end of radiotherapy. |
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| Questionnaire T4 to fill | Behavioral | T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy. |
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| Questionnaire T5 to fill | Behavioral | T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy. |
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| 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 |
| Arras |
| 62000 |
| France |
| Institut Sainte Catherine | Avignon | 84918 | France |
| Centre Pierre Curie - SCP de radiologie et d'imagerie médicale | Beuvry | 62660 | France |
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | 33077 | France |
| CH de BOULOGNE-SUR-MER | Boulogne-sur-Mer | 62321 | France |
| Centre François Baclesse | Caen | 14036 | France |
| Centre Hôpitalier de Compiègne Noyon | Compiègne | 60200 | France |
| Centre Léonard de Vinci | Dechy | 59187 | France |
| Centre Georges François Leclerc | Dijon | 21079 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| Centre Hospitalier André Mignot | Le Chesnay | 78150 | France |
| Centre Bourgogne | Lille | 59000 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| CHRU de Lille | Lille | 59037 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Centre Gray | Maubeuge | 59603 | France |
| ICM Val d'Aurelle | Montpellier | 34298 | France |
| Hôpital Privé des Côtes d'Armor | Plérin | 22190 | France |
| CHU | Poitiers | 86021 | France |
| CH René Dubos | Pontoise | 95300 | France |
| ICC Reims | Reims | 51100 | France |
| Institut Jean Godinot | Reims | 51726 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Institut Curie-Hôpital Huguenin | Saint-Cloud | 92210 | France |
| ICO - Institut Gauducheau | Saint-Herblain | 44805 | France |
| Unité d'Oncologie et d'hématologie ONCOSUD | Toulouse | 31076 | France |
| CHU Bretonneau | Tours | 37000 | France |
| Centre de Cancérologie des Dentellières | Valenciennes | 59300 | France |
| CH Valenciennes | Valenciennes | 59300 | France |
| Hôpital Privé de Villeneuve d'Ascq | Villeneuve-d'Ascq | 59657 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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