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Breast CancerPEPs HORMONONCT02300675

Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

A study testing therapeutic education program in people with Breast Cancer, run by Institut de Cancérologie de la Loire at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
therapeutic education program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
3 sitesFrance
Study dates
May 2014to Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • CH Lyon Sud

    Pierre-Bénite, 69495

  • Hôpital Privé de la Loire

    Saint-Etienne

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42270

Other trials in France

About this study

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

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
Being tested
therapeutic education program
Keywords
therapeutic patient education, patient adherence, empowerment, breast cancer, oral adjuvant endocrine therapy, side effects
Medical subject headings
Breast Neoplasms, Patient Compliance, Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • therapeutic education programBehavioural

Study groups in NCT02300675
Study groupRoleWhat they receive
control armNo interventionPatients follow the classic support prescription of hormonotherapy
therapeutic education programExperimentalPatients follow the 4 sessions of PEP hormonotherapy. The therapeutic education prgram is led by a trained educational team, inside a prevention center : Hygée centre.
Receives: Behavioral: therapeutic education program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measuring changes in patient compliance

    compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study

    Measured: 12 months

Secondary outcomes (5)

  1. measure of the patients' competence in the management of treatment side effects

    measure of the patients' competence with a specific questionnaire of scenarii

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. Measuring the level of patient anxiety

    Measuring the level of patient anxiety with HAD scale

    Measured: 12 months

  4. Measuring the level of confidence of patients related to their treatment

    Measuring the level of confidence with a visual analogic scale

    Measured: 12 months

  5. patients' quality of life assessment

    quality of life evaluated with the EQ-5D questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionAug 2016
  4. Study completionAug 2017

Resources

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
Masking
None (open label)
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02300675
Sponsor's protocol ID
2013-01
Other IDs
2013-A00887-38
Acronym
PEPs HORMONO
Status last verified
Sep 2017
First submitted
15 Apr 2014
Last updated
14 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12556711

  • 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.

    PubMed 15111269

  • 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.

    PubMed 17371769

  • 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.

    PubMed 172189

  • 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.

    PubMed 8901851

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

    PubMed 22870539

  • 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.

    PubMed 2293862

  • 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.

    PubMed 1888251

  • 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.

    PubMed 8501505

  • 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.

    PubMed 11983753

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

    PubMed 8250647

  • 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.

    PubMed 22004071

  • 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.

    PubMed 22331951

  • 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.

    PubMed 16644208

  • 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.

    PubMed 14770426

Questions about this trial

What is this clinical trial studying?

A study testing therapeutic education program in people with Breast Cancer, run by Institut de Cancérologie de la Loire at 3 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measuring changes in patient compliance (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02300675, which also lists 16 linked publications.

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 14 Sep 2017.

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