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Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer

NCT04794075

RecruitingNA

Sponsor: Centre Hospitalier Emile Roux

Conditions: Neoplasm of Breast

Interventions: Therapeutic Education and Nursing Support Program for Supportive Care

Countries: France

To compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (AEs) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Female patients aged 18 to 75 years inclusive
* Patients with non-metastatic breast cancer for whom adjuvant hormone therapy (anti-oestrogen or anti-aromatase) is indicated, depending on the decision of the multidisciplinary consultation meeting.
* Performance status (ECOG) ≤ 2
* Patient able to read and understand French (common use)
* Patient with access to an internet connection (for collection of adverse events and responses to questionnaires on the electronic platform)
* Patient who has been informed and has given written consent to participate in the study
* Patient affiliated to the French social security system or equivalent

Exclusion Criteria:

* Patient with metastatic cancer (stage IV)
* Patient undergoing neoadjuvant hormone therapy
* Patient who started hormone therapy prior to inclusion in the study
* Patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago.
* For patients in the experimental group: Inability of the patient to travel to the hospital to attend the initial assessment day and the proposed group outpatient workshops; follow-up of the program difficult for geographical, physical or other reasons (at the discretion of the investigator).
* For patients in the control group: patients for whom telephone nursing follow-up is planned for 2 months or more or more than 4 sessions of therapeutic education.
* Pregnant and breastfeeding women
* Patient with a documented history of cognitive or psychiatric disorders
* Refusal to participate, protected adult patient, under guardianship or curatorship
Locations (9)
  • Bourg-en-Bresse, France
  • Caluire-et-Cuire, France
  • Carcassonne, France
  • Contamine-sur-Arve, France
  • Le Puy-en-Velay, France
  • Mantes-la-Jolie, France
  • Montélimar, France
  • Saint-Priest-en-Jarez, France
  • Villeurbanne, France