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Completed

NCT Number: NCT02861742

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICO-Site Paul Papin, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Questionnaire T1 to fill

Behavioral

T1 is to fill before chemotherapy.

Questionnaire T2 to fill

Behavioral

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

Questionnaire T3 to fill

Behavioral

T3 is to fill at the end of radiotherapy.

Questionnaire T4 to fill

Behavioral

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

Questionnaire T5 to fill

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Aix Marseille Université
  • Canceropôle Nord Ouest
  • National Cancer Institute, France
  • SIRIC ONCOLille
  • University Charles-de-Gaulle
  • University of Paris 5 - Rene Descartes

Registry information

Official study 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

Acronym: KALICOU3

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Aug 10, 2016
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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