Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

NCT02300675 | Completed

• 2 other identifiers: 2013-012013-A00887-38
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer

Keywords

therapeutic patient education; patient adherence; empowerment; breast cancer; oral adjuvant endocrine therapy; side effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• measure of the patients' competence in the management of treatment side effects

  12 months

• Measuring the level of knowledge of patients related to the disease, the treatment and its side effects

  12 months

• Measuring the level of patient anxiety

  12 months

• Measuring the level of confidence of patients related to their treatment

  12 months

• patients' quality of life assessment

  12 months

Study Arms (2)

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.

Behavioral: therapeutic education program

Interventions

therapeutic education program BEHAVIORAL

therapeutic education program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut de Cancérologie de la Loire: lead

Study Sites (3)

CH Lyon Sud

Pierre-Bénite, 69495, France

Location

Hôpital Privé de la Loire

Saint-Etienne, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Related Publications (16)

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  PMID: 12556711 BACKGROUND

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  PMID: 15111269 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.

  PMID: 17371769 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.

  PMID: 172189 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.

  PMID: 8901851 BACKGROUND

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

  PMID: 22870539 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.

  PMID: 2293862 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.

  PMID: 1888251 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.

  PMID: 8501505 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.

  PMID: 11983753 BACKGROUND

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

  PMID: 8250647 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.

  PMID: 22004071 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.

  PMID: 22331951 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.

  PMID: 16644208 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.

  PMID: 14770426 BACKGROUND

• 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.

  PMID: 21532814 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Patient Compliance; Empowerment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Social Behavior

Study Officials

• Aurélie Bourmaud, MD

  Institut de Cancérologie de la Loire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: November 25, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

FR (3)