Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

Breast Cancer Clinical Trial

— PEPs HORMONO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300675
• Other study ID #: 2013-01
• Secondary ID: 2013-A00887-38
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: September 13, 2017
• Start date: May 2014
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• therapeutic education program

Locations

Country	Name	City	State
France	CH Lyon Sud	Pierre Bénite
France	Hôpital Privé de la Loire	Saint-Etienne
France	Institut de Cancérologie de la Loire	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

References & Publications (16)

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. Epub 2006 Apr 27. — View Citation

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. Review. — View Citation

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. — View Citation

Fisher B, Dignam J, Bryant J, DeCillis A, Wickerham DL, Wolmark N, Costantino J, Redmond C, Fisher ER, Bowman DM, Deschênes 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Horwitz RI, Horwitz SM. Adherence to treatment and health outcomes. Arch Intern Med. 1993 Aug 23;153(16):1863-8. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Pérol D, Toutenu P, Lefranc A, Régnier 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. Review. French. — View Citation

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. — View Citation

Rao RD, Cobleigh MA. Adjuvant endocrine therapy for breast cancer. Oncology (Williston Park). 2012 Jun;26(6):541-7, 550, 552 passim. Review. — View Citation

Sant M, Allemani C, Berrino F, Coleman MP, Aareleid T, Chaplain G, Coebergh JW, Colonna M, Crosignani P, Danzon A, Federico M, Gafà L, Grosclaude P, Hédelin G, Macè-Lesech J, Garcia CM, Møller 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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring changes in patient compliance	compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study	12 months
Secondary	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
Secondary	Measuring the level of knowledge of patients related to the disease, the treatment and its side effects	Measuring the level of knowledge of patients with a specific quizz	12 months
Secondary	Measuring the level of patient anxiety	Measuring the level of patient anxiety with HAD scale	12 months
Secondary	Measuring the level of confidence of patients related to their treatment	Measuring the level of confidence with a visual analogic scale	12 months
Secondary	patients' quality of life assessment	quality of life evaluated with the EQ-5D questionnaire	12 months