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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

Tracking Information
First Submitted Date  ICMJE July 29, 2016
First Posted Date  ICMJE August 10, 2016
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE July 25, 2016
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2016)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2016)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer
Official Title  ICMJE Evaluation of the Impact of Emotional Skills of Young Women (≤ 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Aging
  • Breast Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2016)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02861742
Other Study ID Numbers  ICMJE KALICOU 3-1509
2015-A01808-41 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Oscar Lambret
Study Sponsor  ICMJE Centre Oscar Lambret
Collaborators  ICMJE
  • Université Lille 3
  • Aix Marseille Université
  • University of Paris 5 - Rene Descartes
  • SIRIC ONCOLille
  • Canceropôle Nord Ouest
  • National Cancer Institute, France
Investigators  ICMJE
Principal Investigator: VANLEMMENS Laurence, MD Oscar Lambret
Study Director: Christophe Véronique, Pr Université Lille 3
PRS Account Centre Oscar Lambret
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP