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NCT Number: NCT04794075

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

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.

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Key information

Conditions

Neoplasm of Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Bourg-en-Bresse / Fleyriat, Bourg-en-Bresse, France

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About this study

The main objective of the ETAPH project is to offer breast cancer patients multidisciplinary care that will limit the impact of adverse effects related to hormone therapy treatment and improve their quality of life. The achievement of this objective is based on therapeutic education and nursing follow-up throughout the first year of treatment, which, thanks to active listening and coordination of the various players, will enable global and personalized patient care.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Therapeutic Education and Nursing Support Program for Supportive Care

Other

In addition to the conventional oncology follow-up, patients will participate in an initial educational assessment day within 15 days before or after their first dose of hormone therapy.

A discussion between the patient and the pivot nurse will then make it possible to define personalized objectives, thus guiding the choice of workshops in the outpatient educational program.

Primary outcomes

  1. To compare the effectiveness of adding a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone on the management of adverse events related to adjuvant hormone therapy.

    Time frame: For a year

    The primary endpoint is the score of the 7 adverse events (AEs), graded on a Likert scale from 0 to 4 points from the NCI-CTCAE v5.0, which will be transformed into a single composite endpoint.

    The 7 AEs considered here will be the most frequent and troublesome of the hormone therapy, namely: muscle and/or joint pain, hot flashes, headache, fatigue, insomnia/sleep disturbance, weight gain, nausea. This collection will be done initially (T0) and then monthly by the patients.

Secondary outcomes

  1. To compare the effectiveness of adding the program to conventional management alone in terms of quality of life for patients on hormone therapy at baseline (Day 0), Month 6 and Month 12.

    Time frame: Change from baseline at Month 6 and Month 12

    The score of the validated Quality of Life of Cancer Patients (EORTC-QLQ-C30) self-questionnaire score, performed at Day 0, Month 6 and Month 12 after initiation of hormone therapy

  2. To compare the effectiveness of adding the program to conventional management alone in terms of sleep quality at baseline (Day 0), Month 6 and Month 12.

    Time frame: Change from baseline at Month 6 and Month 12

    the score of the validated Pittsburgh sleep quality self-questionnaire during the past month, performed at Day 0, Month 6 and Month 12 after initiation of hormone therapy

  3. To compare the effectiveness of adding the program to conventional management alone in terms of drug use for the management of adverse events throughout the study.

    Time frame: From date of first Hormone Therapy intake to 12 months

    The INN name,the daily dosage and duration (number of days) of medication taken between Day 0 and 12 months, will be assessed to compare between the experimental ans the control group in term of medication use

  4. To compare the effectiveness of adding the program to conventional management alone in terms of therapeutic compliance at Month 6 and Month 12.

    Time frame: Change from Month 6 and Month 12

    GIRERD's subjective compliance self-questionnaire score will be filled in at Month 6 and Month 12.

  5. To compare the effectiveness of adding the program to conventional management alone in terms of patients' confidence regarding the use of hormone therapy at Day 0, Month 6 and Month 12.

    Time frame: Change from baseline at Month 6 and Month 12

    Patients' confidence in their treatment, assessed on a numerical scale from 0 to 10, measured at Day 0, Month 6 and Month 12.

  6. To compare the effectiveness of adding the program to conventional management alone in terms of patients' level of knowledge about the disease and treatment.

    Time frame: Change from baseline at Month 2

    Score obtained in the knowledge quizz conducted in Day 0, then at 2 months. This questionnaire is developed by our team based on Likert scales from 1 to 4.

  7. To compare the effectiveness of adding the program to conventional management alone in terms of patients' satisfaction with their care at Month 12.

    Time frame: For a year

    Score of satisfaction with patient care in relation to the needs they have had over the past 12 months. This questionnaire is developed by our team based on Likert scales from 0 to 3.

  8. To compare the effectiveness of adding the program to conventional management alone in terms of medico-economic impact of the program, in terms of cost-utility.

    Time frame: For a year

    the cost-utility ratio of the program will be calculated by estimating the costs incurred/avoided by this program and the evolution of the quality of life of the patients at different times.

  9. To assess patient interest in and adherence to the proposed program in the experimental group.

    Time frame: For a year

    Refusal rate and program participation rate The rate of premature exit or loss of sight The number and type of workshops attended by patients Evaluation of program content based on Likert scales ranging from 1 to 4.

  10. To describe the non-drug means used by patients to manage their adverse events and their use of supportive care during the study.

    Time frame: For a year

    Patients' non-drug management of side effects and use of supportive care will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Camille FARCY, PhD

CONTACT

[email protected]

+33 4 71 04 31 27

Émilie GADEA, PhD

CONTACT

[email protected]

+33 4 71 04 35 38

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Emile Roux

Other

Collaborators

  • University Hospital, Clermont-Ferrand
  • Walisco

Registry information

Official study title

Programme d'Éducation Thérapeutique et d'Accompagnement Infirmier Vers Les Soins de Support, Chez Les Patientes Sous Hormonothérapie Pour un Cancer du Sein Non métastatique

Acronym: ETAPH

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Mar 11, 2021
Registry last updated
Aug 5, 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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