Neoplasm of BreastETAPHNCT04794075
Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
A study testing Therapeutic Education and Nursing Support Program for Supportive Care in people with Neoplasm of Breast, run by Centre Hospitalier Emile Roux at 9 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Neoplasm of Breast
- What is being tested?
- Therapeutic Education and Nursing Support Program for Supportive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 9 sitesFrance
- Study dates
- 9 Aug 2021to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Pregnant and breastfeeding women
- Patient with a documented history of cognitive or psychiatric disorders
- Refusal to participate, protected adult patient, under guardianship or curatorship
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Centre Hospitalier de Bourg-en-Bresse / Fleyriat
Bourg-en-Bresse, 01000
Patrick ARNAUD-COFFIN, MD, +33 4 74 45 43 38, parnaudcoffin@ch-bourg01.fr
Mélanie CHAGROS, +33 4 74 45 41 34, mchagros@ch-bourg01.fr
- Recruiting
Clinique De L'infirmerie Protestante De Lyon
Caluire-et-Cuire, 69300
Christine DOLMAZON, MD, +33 4 72 00 71 30, medecineinterne@infirmerie-protestante.com
Polina KUKLINA, +33 4 26 29 79 27, Polina.KUKLINA@infirmerie-protestante.com
- Recruiting
CH de Carcassonne
Carcassonne
Samir HACENE, MD, +33 4 68 24 29 77, samir.hacene@ch-carcassonne.fr
Pauline BAILLETTE-TEXIER, +33 4 68 24 23 72, pauline.baillette@ch-carcassonne.fr
- Not yet recruiting
CHAL - Centre Hospitalier Alpes Léman
Contamine-sur-Arve, 74130
Mansour RASTKHAH, MD, +33 4 50 82 22 72, mrastkhah@ch-alpes-leman.fr
Sandrine MEGESSIER, +33 4 50 82 30 39, smegessier@ch-alpes-leman.fr
- Recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
Emilie Gadea, PhD, projetetaph@ch-lepuy.fr
Camille FARCY, PhD, +33 4 71 04 31 27, camille.farcy@ch-lepuy.fr
- Recruiting
Centre Hospitalier François Quesnay
Mantes-la-Jolie, 78200
Claire GOYARD, +33 6 28 41 59 79, c.goyard87@gmail.fr
Claire GOYARD
- Not yet recruiting
Groupement Hospitalier Portes de Provence
Montélimar, 26200
Annabelle GAUMIER, MD, +33 4 75 53 40 52, annabelle.gaumier@ghpp.fr
Corinne MOURIOUX, +33 4 75 53 43 89, corinne.mourioux@ghpp.fr
- Recruiting
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270
Elodie GUILLAUME, MD, +33 4 77 91 71 02, elodie.guillaume@chu-st-etienne.fr
Kenza KALI, +33 4 77 82 29 74, Kenza.KALI@chu-st-etienne.fr
- Recruiting
Médipôle Lyon-Villeurbanne
Villeurbanne, 69100
Victor PASSERAT, MD, +33 4 26 68 67 67, v.passerat@free.fr
Caroline JAFFRE, C.JAFFRE@resamut.fr
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Neoplasm of Breast
- Being tested
- Therapeutic Education and Nursing Support Program for Supportive Care
- Keywords
- Therapeutic Education, Nursing Support Program, Hormone Therapy, Non-metastatic Breast Cancer, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education and Nursing Support Program for Supportive CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group with the therapeutic education and nursing support program | Experimental | In addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day. Receives: Other: Therapeutic Education and Nursing Support Program for Supportive Care |
| Control group | No intervention | Patients will have the conventional oncology follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: For a year
Secondary outcomes (10)
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.
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
Measured: Change from baseline at Month 6 and Month 12
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.
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
Measured: Change from baseline at Month 6 and Month 12
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.
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
Measured: From date of first Hormone Therapy intake to 12 months
To compare the effectiveness of adding the program to conventional management alone in terms of therapeutic compliance at Month 6 and Month 12.
GIRERD's subjective compliance self-questionnaire score will be filled in at Month 6 and Month 12.
Measured: Change from Month 6 and Month 12
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.
Patients' confidence in their treatment, assessed on a numerical scale from 0 to 10, measured at Day 0, Month 6 and Month 12.
Measured: Change from baseline at Month 6 and Month 12
To compare the effectiveness of adding the program to conventional management alone in terms of patients' level of knowledge about the disease and treatment.
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.
Measured: Change from baseline at Month 2
To compare the effectiveness of adding the program to conventional management alone in terms of patients' satisfaction with their care at Month 12.
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.
Measured: For a year
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.
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.
Measured: For a year
To assess patient interest in and adherence to the proposed program in the experimental group.
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.
Measured: For a year
To describe the non-drug means used by patients to manage their adverse events and their use of supportive care during the study.
Patients' non-drug management of side effects and use of supportive care will be recorded.
Measured: For a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start9 Aug 2021
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm of BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experiment group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand, Walisco
- Responsible party
- Sponsor
- Investigators
- Séverine Breysse, Principal investigator, Centre Hospitalier Emile Roux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794075
- Sponsor's protocol ID
- RIPH2_BREYSSE_ETAPH
- Other IDs
- 2020-A03074-35
- Acronym
- ETAPH
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2021
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study sponsor is the owner of the data and no use or transmission to a third party may be made without its prior consent. All information resulting from this clinical research protocol is considered confidential.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04794075
- Acronym / sponsor ID
- ETAPH / RIPH2_BREYSSE_ETAPH
- Conditions
- Neoplasm of Breast
- Keywords
- Therapeutic Education, Nursing Support Program, Hormone Therapy, Non-metastatic Breast Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand, Walisco
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experiment group
| Arm | Type | Receives |
|---|---|---|
| Experimental group with the therapeutic education and nursing support program | Experimental | Other: Therapeutic Education and Nursing Support Program for Supportive CareIn addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day. |
| Control group | No intervention | –Patients will have the conventional oncology follow-up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Education and Nursing Support Program for Supportive CareIn 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. | Other | Experimental group with the therapeutic education and nursing support program |
Primary outcome
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.
10 secondary outcomes
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
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
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
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
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
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
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
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
To assess patient interest in and adherence to the proposed program in the experimental group.
Time frame: For a year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. The study sponsor is the owner of the data and no use or transmission to a third party may be made without its prior consent. All information resulting from this clinical research protocol is considered confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Séverine Breysse principal investigator
Centre Hospitalier Emile Roux
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education and Nursing Support Program for Supportive Care in people with Neoplasm of Breast, run by Centre Hospitalier Emile Roux at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Émilie GADEA, PhD (+33 4 71 04 35 38, projetetaph@ch-lepuy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.