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Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer (KALICOU3)

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ClinicalTrials.gov Identifier: NCT02861742
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
Université Lille 3
Aix Marseille Université
University of Paris 5 - Rene Descartes
SIRIC ONCOLille
Canceropôle Nord Ouest
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aging Breast Cancer 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 Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Impact of Emotional Skills of Young Women (≤ 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer
Actual Study Start Date : July 25, 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study procedure
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
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.

Behavioral: Questionnaire T1 to fill
T1 is to fill before chemotherapy.

Behavioral: Questionnaire T2 to fill
T2 is to fill after the 6th cycle of chemotherapy.

Behavioral: Questionnaire T3 to fill
T3 is to fill at the end of radiotherapy.

Behavioral: Questionnaire T4 to fill
T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy.

Behavioral: Questionnaire T5 to fill
T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy.




Primary Outcome Measures :
  1. BCI-YW ( Breast Cancer Inventory - Young Women) [ Time Frame: an average of 1 year ]
    To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance

  2. BCI-Partner's YW ( Breast Cancer Inventory - Young Women Partner's) [ Time Frame: an average of 1 year ]
    To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance

  3. PEC (Profile of Emotional Competences) [ Time Frame: an average of 1 year ]
    To evaluate the effect of emotional skills of patients and partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance


Secondary Outcome Measures :
  1. BCI-YW [ Time Frame: an average of 1 year ]
    To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner

  2. BCI-Partner's YW [ Time Frame: an average of 1 year ]
    To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner

  3. SF 36 (Short Form 36 - Health Survey) [ Time Frame: an average of 1 year ]
    To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner

  4. Hospital Anxiety-Depression Scale [ Time Frame: an average of 1 year ]
    To evaluate the dyadic effect's emotional skills and treatment repercussion on adjustment to cancer as well as on partner

  5. Profile of Emotional Competences [ Time Frame: an average of 1 year ]
    To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner

  6. MAVA (Measure of affectivity: Valence/Activation) [ Time Frame: an average of 1 year ]
    To evaluate the dyadic effect's emotional skills on adjustment to cancer as well as on partner



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861742


Contacts
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Contact: Decoupigny Emilie +33 (0) 3 20 29 59 18 e-decoupigny@o-lambret.fr
Contact: VANLEMMENS Laurence, MD +33 (0) 3 20 29 59 18 l-vanlemmens@o-lambret.fr

Locations
Show Show 33 study locations
Sponsors and Collaborators
Centre Oscar Lambret
Université Lille 3
Aix Marseille Université
University of Paris 5 - Rene Descartes
SIRIC ONCOLille
Canceropôle Nord Ouest
National Cancer Institute, France
Investigators
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Principal Investigator: VANLEMMENS Laurence, MD Oscar Lambret
Study Director: Christophe Véronique, Pr Université Lille 3
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02861742    
Other Study ID Numbers: KALICOU 3-1509
2015-A01808-41 ( Other Identifier: ANSM )
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases