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 (EUTACAM)

Institut Claudius Regaud

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.

Study type: Interventional

Funder types: Other

Identifiers

NCT04740697

20 SEIN 13

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years at entry into the study.
2. Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
3. Patients treated with tamoxifen for a maximum of 1 to 3 years.
4. Patient affiliated with a Social Security system in France.
5. Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion criteria

1. Pregnant or breastfeeding women.
2. 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.
3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Patient with localized breast cancer.

Other group

Treatment:

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