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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00887-38 | Other Identifier | Agence Nationale de Sécurité du Médicament |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control arm | No Intervention | Patients follow the classic support prescription of hormonotherapy | |
| therapeutic education program | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic education program | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| measuring changes in patient compliance | compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| measure of the patients' competence in the management of treatment side effects | measure of the patients' competence with a specific questionnaire of scenarii | 12 months |
| Measuring the level of knowledge of patients related to the disease, the treatment and its side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aurélie Bourmaud, MD | Institut de Cancérologie de la Loire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Lyon Sud | Pierre-Bénite | 69495 | France | |||
| Hôpital Privé de la Loire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12556711 | Background | Golant 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. | |
| 15111269 | Background | Diefenbach 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010349 | Patient Compliance |
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Measuring the level of knowledge of patients with a specific quizz |
| 12 months |
| Measuring the level of patient anxiety | Measuring the level of patient anxiety with HAD scale | 12 months |
| Measuring the level of confidence of patients related to their treatment | Measuring the level of confidence with a visual analogic scale | 12 months |
| patients' quality of life assessment | quality of life evaluated with the EQ-5D questionnaire | 12 months |
| Saint-Etienne |
| France |
| Institut de Cancérologie de la Loire | Saint-Priest-en-Jarez | 42270 | France |
| 17371769 | Background | Perol 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. |
| 172189 | Background | Persijn 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. |
| 8901851 | Background | Fisher 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. |
| 22870539 | Background | Rao RD, Cobleigh MA. Adjuvant endocrine therapy for breast cancer. Oncology (Williston Park). 2012 Jun;26(6):541-7, 550, 552 passim. |
| 2293862 | Background | Lebovits 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. |
| 1888251 | Background | Love RR, Cameron L, Connell BL, Leventhal H. Symptoms associated with tamoxifen treatment in postmenopausal women. Arch Intern Med. 1991 Sep;151(9):1842-7. |
| 8501505 | Background | Waterhouse DM, Calzone KA, Mele C, Brenner DE. Adherence to oral tamoxifen: a comparison of patient self-report, pill counts, and microelectronic monitoring. J Clin Oncol. 1993 Jun;11(6):1189-97. doi: 10.1200/JCO.1993.11.6.1189. |
| 11983753 | Background | Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst. 2002 May 1;94(9):652-61. doi: 10.1093/jnci/94.9.652. |
| 8250647 | Background | Horwitz RI, Horwitz SM. Adherence to treatment and health outcomes. Arch Intern Med. 1993 Aug 23;153(16):1863-8. |
| 22004071 | Background | Banning M. Adherence to adjuvant therapy in post-menopausal breast cancer patients: a review. Eur J Cancer Care (Engl). 2012 Jan;21(1):10-9. doi: 10.1111/j.1365-2354.2011.01295.x. Epub 2011 Oct 18. |
| 22331951 | Background | Henry NL, Azzouz F, Desta Z, Li L, Nguyen AT, Lemler S, Hayden J, Tarpinian K, Yakim E, Flockhart DA, Stearns V, Hayes DF, Storniolo AM. Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer. J Clin Oncol. 2012 Mar 20;30(9):936-42. doi: 10.1200/JCO.2011.38.0261. Epub 2012 Feb 13. |
| 16644208 | Background | Atkins L, Fallowfield L. Intentional and non-intentional non-adherence to medication amongst breast cancer patients. Eur J Cancer. 2006 Sep;42(14):2271-6. doi: 10.1016/j.ejca.2006.03.004. Epub 2006 Apr 27. |
| 14770426 | Background | Sant M, Allemani C, Berrino F, Coleman MP, Aareleid T, Chaplain G, Coebergh JW, Colonna M, Crosignani P, Danzon A, Federico M, Gafa L, Grosclaude P, Hedelin G, Mace-Lesech J, Garcia CM, Moller H, Paci E, Raverdy N, Tretarre B, Williams EM; European Concerted Action on Survival and Care of Cancer Patients (EUROCARE) Working Group. Breast carcinoma survival in Europe and the United States. Cancer. 2004 Feb 15;100(4):715-22. doi: 10.1002/cncr.20038. |
| 21532814 | Result | Hohneker J, Shah-Mehta S, Brandt PS. Perspectives on adherence and persistence with oral medications for cancer treatment. J Oncol Pract. 2011 Jan;7(1):65-7. doi: 10.1200/JOP.2010.000076. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012919 | Social Behavior |