Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer

Study Overview
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Brief Summary
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This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer. 200 patients will be included in the study. Each patient will be followed for one day.

Official Title
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Pilot Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at entry into the study. Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen. Patients treated with tamoxifen for a maximum of 1 to 3 years. Patient affiliated with a Social Security system in France. Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures. Exclusion Criteria: Pregnant or breastfeeding women. Any psychological, family, geographical or sociological condition that does not allow the medical follow-up and/or the procedures foreseen in the study protocol to be respected. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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Female

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: Patient with localized breast cancer.<br> | Other: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.<br>* Each included patient will be referred to the health care staff for a blood sample: for the determination of the residual plasma concentration of tamoxifen and its active metabolites, for the constitution of a biobank. Patients will then complete a questionnaire to collect information on tamoxifen intake and adherence (via the GIRERD questionnaire), as well as possible Alternative and Complementary Therapeutics (ACT) intake (reason for use, type of ACT, ...).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who adhere to tamoxifen treatment. | This outcome will be assessed by the completion of the GIRERD questionnaire by the patient. | 18 months after the start of the research | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients taking ACT. |  | 18 months after the start of the research | 
| Rate of patients consuming turmeric-based dietary supplements. |  | 18 months after the start of the research | 
| Plasma concentration of tamoxifen in patients. |  | 18 months after the start of the research | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Tamoxifen, Alternative and complementary therapies, Treatment adherence, Turmeric