Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Cancer
Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Study protocol

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder

Authors: Yunxin He, Eng Hooi Tan, Andrea Li Ann Wong, Chuan Chien Tan, Patrick Wong, Soo Chin Lee, Bee Choo Tai

Published in: BMC Cancer | Issue 1/2018

Login to get access

Abstract

Background

Medication adherence refers to whether a patient takes medication according to the frequency prescribed, or continues to take a prescribed medication. Inadequate adherence to medication may cause alterations in risk-benefit ratios, resulting in reduced benefits, increased risks or both, and is significantly associated with adverse clinical outcomes and higher healthcare costs. We aim to examine the effect of a computer generated short message service (SMS) reminder in improving medication adherence, and inhibiting the aromatisation process amongst breast cancer women receiving oral aromatase inhibitor therapy.

Methods/Design

In this randomised controlled trial, eligible patients will be equally allocated to receive either SMS reminder or standard care. The former receives weekly SMS reminder to take medication while the latter does not receive any. The primary endpoint of medication adherence at 1-year is assessed using the Simplified Medication Adherence Questionnaire, and compared using the χ2 test. Adjustment for baseline covariate and potential confounders will be made using the logistic regression. Secondary outcomes involving estrone and androstenedione levels will be compared using the analysis of covariance, whereas the estradiol levels (< 18.4 pmol/L versus ≥18.4 pmol/L) will be compared using the χ2 test, and the logistic regression. Further, the assessment of knowledge, attitude, behaviour, and barriers and facilitating factors of medication adherence will be made via logistic regression.

Discussion

This will be the first study to evaluate short-term clinical outcomes from SMS reminder for breast cancer patients on aromatase inhibitor therapy. Random allocation to SMS reminder or control arm ensures that patients in both arms will be comparable with respect to demographic and clinical characteristics, and any difference in outcomes can be attributed to the intervention. Participants are not blinded to the assignment of intervention, thus there may be potential for bias in outcome assessments.

Trial registration

NCT02524548. Retrospectively registered on 17 August 2015.
Literature
1.
Delamater AM. Improving patient adherence. Clinical Diabetes. 2006;24:71–7.CrossRef
2.
3.
DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002;40(9):794–811.CrossRefPubMed
4.
Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, Hoctin-Boes G, Houghton J, Locker G, Tobias J. Results of the ATAC (Arimidex, tamoxifen, alone or in combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet. 2005;365(9453):60–2.CrossRefPubMed
5.
Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation. 2009;119(23):3028–35.CrossRefPubMed
6.
7.
8.
Fabian CJ. The what, why and how of aromatase inhibitors: hormonal agents for treatment and prevention of breast cancer. Int J Clin Pract. 2007;61(12):2051–63.CrossRefPubMedPubMedCentral
9.
Partridge AH, LaFountain A, Mayer E, Taylor BS, Winer E, Asnis-Alibozek A. Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol. 2008;26:556–62.CrossRefPubMed
10.
Key T, Appleby P, Barnes I, Reeves G. Endogenous sex hormones and breast cancer in postmenopausal women: reanalysis of nine prospective studies. J Natl Cancer Inst. 2002;94(8):606–16.CrossRefPubMed
11.
Johnston SR, Dowsett M. Aromatase inhibitors for breast cancer: lessons from the laboratory. Nat Rev Cancer. 2003;3(11):821–31.CrossRefPubMed
12.
Cao A, Zhang J, Liu X, Wu W, Liu Y, Fan Z, Zhang A, Zhou T, Fu P, Wang S, et al. Health-related quality of life of postmenopausal Chinese women with hormone receptor-positive early breast cancer during treatment with adjuvant aromatase inhibitors: a prospective, multicenter, non-interventional study. Health Qual Life Outcomes. 2016;14:51.CrossRefPubMedPubMedCentral
13.
Ryden L, Heibert Arnlind M, Vitols S, Hoistad M, Ahlgren J. Aromatase inhibitors alone or sequentially combined with tamoxifen in postmenopausal early breast cancer compared with tamoxifen or placebo - meta-analyses on efficacy and adverse events based on randomized clinical trials. Breast. 2016;26:106–14.CrossRefPubMed
14.
Francis PA, Regan MM, Fleming GF, Láng I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015;372(5):436–46.CrossRefPubMed
15.
16.
Murphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat. 2012;134(2):459–78.CrossRefPubMedPubMedCentral
17.
Verma S, Madarnas Y, Sehdev S, Martin G, Bajcar J. Patient adherence to aromatase inhibitor treatment in the adjuvant setting. Curr Oncol. 2011;18(Suppl 1):S3–9.PubMedPubMedCentral
18.
Valachis A, Garmo H, Weinman J, Fredriksson I, Ahlgren J, Sund M, Holmberg L. Effect of selective serotonin reuptake inhibitors use on endocrine therapy adherence and breast cancer mortality: a population-based study. Breast Cancer Res Treat. 2016;159(2):293–303.CrossRefPubMedPubMedCentral
19.
Costa E, Giardini A, Savin M, Menditto E, Lehane E, Laosa O, Pecorelli S, Monaco A, Marengoni A. Interventional tools to improve medication adherence: review of literature. Patient Prefer Adherence. 2015;9:1303–14.CrossRefPubMedPubMedCentral
20.
Greer JA, Amoyal N, Nisotel L, Fishbein JN, MacDonald J, Stagl J, Lennes I, Temel JS, Safren SA, Pirl WF. A systematic review of adherence to oral antineoplastic therapies. Oncologist. 2016;21(3):354–76.CrossRefPubMedPubMedCentral
21.
22.
Park LG, Howie-Esquivel J, Dracup K. A quantitative systematic review of the efficacy of mobile phone interventions to improve medication adherence. J Adv Nurs. 2014;70(9):1932–53.CrossRefPubMed
23.
24.
Hanauer DA, Wentzell K, Laffel N, Laffel LM. Computerized automated reminder diabetes system (CARDS): E-mail and SMS cell phone text messaging reminders to support diabetes management. Diabetes Technol Ther. 2009;11(2):99–106.CrossRefPubMedPubMedCentral
25.
Malcolm SE, Ng JJ, Rosen RK, Stone VE. An examination of HIV/AIDS patients who have excellent adherence to HAART. AIDS Care. 2003;15(2):251–61.CrossRefPubMed
26.
Molfenter TD, Bhattacharya A, Gustafson DH. The roles of past behavior and health beliefs in predicting medication adherence to a statin regimen. Patient Prefer Adherence. 2012;6:643–51.CrossRefPubMedPubMedCentral
27.
Yang GS, Kim HJ, Griffith KA, Zhu S, Dorsey SG, Renn CL. Interventions for the treatment of aromatase inhibitor-associated arthralgia in breast cancer survivors: a systematic review and meta-analysis. Cancer Nurs. 2017;40(4):E26–41.CrossRefPubMed
28.
Neugut AI, Zhong X, Wright JD, Accordino M, Yang J, Hershman DL. Nonadherence to medications for chronic conditions and nonadherence to adjuvant hormonal therapy in women with breast cancer. JAMA Oncol. 2016;2(10):1326–32.CrossRefPubMed
29.
Bright EE, Petrie KJ, Partridge AH, Stanton AL. Barriers to and facilitative processes of endocrine therapy adherence among women with breast cancer. Breast Cancer Res Treat. 2016;158(2):243–51.CrossRefPubMed
30.
Hsieh K-P, Chen L-C, Cheung K-L, Chang C-S, Yang Y-H. Interruption and non-adherence to long-term adjuvant hormone therapy is associated with adverse survival outcome of breast cancer women-an Asian population-based study. PLoS One. 2014;9(2):e87027.CrossRefPubMedPubMedCentral
31.
Vervloet M, Linn AJ, van Weert JC, De Bakker DH, Bouvy ML, Van Dijk L. The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature. J Am Med Inform Assoc. 2012;19(5):696–704.CrossRefPubMedPubMedCentral
32.
Ortega Suárez FJ, Sánchez Plumed J, Pérez Valentín MA, Pereira Palomo P, Muñoz Cepeda MA, Lorenzo Aguiar D. Validation on the simplified medication adherence questionnaire (SMAQ) in renal transplant patients on tacrolimus. Nefrologia. 2011;31(6):690–6.PubMed
33.
Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health. 1999;14:1–24.CrossRef
34.
Matza LS, Park J, Coyne KS, Skinner EP, Malley KG, Wolever RQ. Derivation and validation of the ASK-12 adherence barrier survey. Ann Pharmacother. 2009;43(10):1621–30.CrossRefPubMed
35.
Garfield S, Clifford S, Eliasson L, Barber N, Willson A. Suitability of measures of self-reported medication adherence for routine clinical use : a systematic review. BMC Med Res Methodol. 2011;11:149.CrossRefPubMedPubMedCentral
36.
37.
Graetz I, McKillop CN, Stepanski EJ, Vidal GA, Lee SS. Use of a web-based app to improve breast cancer symptom management and aromatase inhibitor adherence. J Clin Oncol. 2017;35(Suppl 5):89.CrossRef
38.
Fishbein JN, Nisotel LE, MacDonald JJ, Amoyal Pensak N, Jacobs JM, Flanagan C, Jethwani K, Greer JA. Mobile application to promote adherence to oral chemotherapy and symptom management: a protocol for design and development. JMIR Res Protoc. 2017;6(4):e62.CrossRefPubMedPubMedCentral
39.
Chung IY, Kang E, Yom CK, Kim D, Sun Y, Hwang Y, Jang JY, Kim SW. Effect of short message service as a reminder on breast self-examination in breast cancer patients: a randomized controlled trial. J Telemed Telecare. 2015;21(3):144–50.CrossRefPubMed
40.
Vidal C, Garcia M, Benito L, Milà N, Binefa G, Moreno V. Use of text-message reminders to improve participation in a population-based breast Cancer screening program. J Med Syst. 2014;38(9):118.CrossRefPubMed
41.
Gallicchio L, Calhoun C, Helzlsouer K. A prospective study of aromatase inhibitor therapy initiation and self-reported side effects. Support Care Cancer. 2017;25(9):2697–705.CrossRefPubMed
42.
Jacob L, Hadji P, Kostev K. Age-related differences in persistence in women with breast cancer treated with tamoxifen or aromatase inhibitors in Germany. J Geriatr Oncol. 2016;7(3):169–75.CrossRefPubMed
43.
Hershman DL. Sticking to it: improving outcomes by increasing adherence. J Clin Oncol. 2016;34(21):2440–2.CrossRefPubMed
44.
Salgado TM, Davis EJ, Farris KB, Fawaz S, Batra P, Henry NL. Identifying socio-demographic and clinical characteristics associated with medication beliefs about aromatase inhibitors among postmenopausal women with breast cancer. Breast Cancer Res Treat. 2017;163(2):311–9.CrossRefPubMed
Metadata
Title
Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder
Authors
Yunxin He
Eng Hooi Tan
Andrea Li Ann Wong
Chuan Chien Tan
Patrick Wong
Soo Chin Lee
Bee Choo Tai
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4660-7

Other articles of this Issue 1/2018

BMC Cancer 1/2018 Go to the issue

Research article

Porcine circovirus type 2 ORF3 protein induces apoptosis in melanoma cells

Research article

Contribution of KCTD12 to esophageal squamous cell carcinoma

Research article

Oncological and reproductive outcomes of adenocarcinoma in situ of the cervix managed with the loop electrosurgical excision procedure

Research article

HPV-16 E7 expression up-regulates phospholipase D activity and promotes rapamycin resistance in a pRB-dependent manner

Research article

Are the indications for postoperative radiotherapy in the NCCN guidelines for patients with gastric adenocarcinoma too broad? A study based on the SEER database

Research article

Calcium-activated chloride channel regulator 1 as a prognostic biomarker in pancreatic ductal adenocarcinoma
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine
Image Credits