Clinical trial · Interventional
Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy
Development and Evaluation of a Therapeutic Education Intervention Focused on the Accession of Patients Treated With Hormonal Therapy in the Management of Breast Cancer: PEPs Hormonotherapy
NCT02300675CI-TRIAL-00029526PEPs HORMONOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the feasibility and the effectiveness of a patient education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient education and medical oncologists.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic education program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control arm
- description
- Patients follow the classic support prescription of hormonotherapy
- type
- EXPERIMENTAL
- label
- therapeutic education program
- description
- Patients follow the 4 sessions of PEP hormonotherapy. The therapeutic education prgram is led by a trained educational team, inside a prevention center : Hygée centre.
- interventionNames
- Behavioral: therapeutic education program
Primary outcomes (1)
- measure
- measuring changes in patient compliance
- timeFrame
- 12 months
- description
- compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged over 18 * History of breast cancer * Medical prescription for an adjuvant hormonal treatment (anti-estrogens and / or aromatase inhibitors) as monotherapy or in combination with other treatments * Affiliated to a social security scheme Exclusion Criteria: * Refusal to participate, patient protected by guardianship. * Patient unable to understand the study or unable to follow the education sessions. * Patient with documented cognitive or psychiatric history. * Geographical remotness (more than 100 Kms).
References
Publications (16)
- BACKGROUNDGolant M, Altman T, Martin C. Managing cancer side effects to improve quality of life: a cancer psychoeducation program. Cancer Nurs. 2003 Feb;26(1):37-44; quiz 45-6. doi: 10.1097/00002820-200302000-00005. PMID 12556711
- BACKGROUNDDiefenbach MA, Butz BP. A multimedia interactive education system for prostate cancer patients: development and preliminary evaluation. J Med Internet Res. 2004 Jan 21;6(1):e3. doi: 10.2196/jmir.6.1.e3. PMID 15111269
- BACKGROUNDPerol D, Toutenu P, Lefranc A, Regnier V, Chvetzoff G, Saltel P, Chauvin F. [Therapeutic education in oncology: involving patient in the management of cancer]. Bull Cancer. 2007 Mar;94(3):267-74. French. PMID 17371769
- BACKGROUNDPersijn JP, Korsten CB, Engelsman E. Oestrogen and androgen receptors in breast cancer and response to endocrine therapy. Br Med J. 1975 Nov 29;4(5995):503. doi: 10.1136/bmj.4.5995.503. No abstract available. PMID 172189
- BACKGROUNDFisher B, Dignam J, Bryant J, DeCillis A, Wickerham DL, Wolmark N, Costantino J, Redmond C, Fisher ER, Bowman DM, Deschenes L, Dimitrov NV, Margolese RG, Robidoux A, Shibata H, Terz J, Paterson AH, Feldman MI, Farrar W, Evans J, Lickley HL. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996 Nov 6;88(21):1529-42. doi: 10.1093/jnci/88.21.1529. PMID 8901851
- BACKGROUNDRao RD, Cobleigh MA. Adjuvant endocrine therapy for breast cancer. Oncology (Williston Park). 2012 Jun;26(6):541-7, 550, 552 passim. PMID 22870539
- BACKGROUNDLebovits AH, Strain JJ, Schleifer SJ, Tanaka JS, Bhardwaj S, Messe MR. Patient noncompliance with self-administered chemotherapy. Cancer. 1990 Jan 1;65(1):17-22. doi: 10.1002/1097-0142(19900101)65:13.0.co;2-i.