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Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study

BACKGROUND: In women with hormone receptor positive breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel eHealth tool (OPTIMU...

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Autores principales: Meguerditchian, Ari, Tamblyn, Robyn, Meterissian, Sarkis, Law, Susan, Prchal, Jaroslav, Winslade, Nancy, Stern, Donna
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5118585/
https://www.ncbi.nlm.nih.gov/pubmed/27821385
http://dx.doi.org/10.2196/resprot.6519
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author Meguerditchian, Ari
Tamblyn, Robyn
Meterissian, Sarkis
Law, Susan
Prchal, Jaroslav
Winslade, Nancy
Stern, Donna
author_facet Meguerditchian, Ari
Tamblyn, Robyn
Meterissian, Sarkis
Law, Susan
Prchal, Jaroslav
Winslade, Nancy
Stern, Donna
author_sort Meguerditchian, Ari
collection PubMed
description BACKGROUND: In women with hormone receptor positive breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel eHealth tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians. OBJECTIVES: The objectives of the study are to determine the effectiveness of a patient-specific, real-time eHealth alert delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation as well as to assess integration of eHealth alerts regarding deviations from best practices in administration of AET by cancer care teams. METHODS: A prospective, 2-group controlled comparison pilot study will be conducted at 2 urban, McGill University–affiliated hospitals, the Royal Victoria Hospital and St. Mary’s Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 years. Health care professionals at the intervention site will have access to the eHealth tool, which will report to them in real-time medical events with known associations to AET discontinuation, an AET adherence monitor, and a discontinuation alert. Cox proportional hazard ratios with 95% confidence intervals will estimate risks of AET discontinuation. Tests for significance will be 2-sided with a significance level of P<.05. RESULTS: This protocol has been approved and funded by the Canadian Institutes of Health Research. The study will evaluate site-level differences between AET discontinuation and AET adherence and assess care team actions at the intervention site. Participant enrollment into this project is expected to start September 2016 with primary data ready to present by June 2018. CONCLUSION: This study will offer an opportunity to verify the feasibility of integrating an eHealth tool that aims to improve the long-term management of breast cancer in a high-risk population by allowing more timely intervention to prevent or rapidly address AET discontinuation.
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spelling pubmed-51185852016-12-01 Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study Meguerditchian, Ari Tamblyn, Robyn Meterissian, Sarkis Law, Susan Prchal, Jaroslav Winslade, Nancy Stern, Donna JMIR Res Protoc Original Paper BACKGROUND: In women with hormone receptor positive breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel eHealth tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians. OBJECTIVES: The objectives of the study are to determine the effectiveness of a patient-specific, real-time eHealth alert delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation as well as to assess integration of eHealth alerts regarding deviations from best practices in administration of AET by cancer care teams. METHODS: A prospective, 2-group controlled comparison pilot study will be conducted at 2 urban, McGill University–affiliated hospitals, the Royal Victoria Hospital and St. Mary’s Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 years. Health care professionals at the intervention site will have access to the eHealth tool, which will report to them in real-time medical events with known associations to AET discontinuation, an AET adherence monitor, and a discontinuation alert. Cox proportional hazard ratios with 95% confidence intervals will estimate risks of AET discontinuation. Tests for significance will be 2-sided with a significance level of P<.05. RESULTS: This protocol has been approved and funded by the Canadian Institutes of Health Research. The study will evaluate site-level differences between AET discontinuation and AET adherence and assess care team actions at the intervention site. Participant enrollment into this project is expected to start September 2016 with primary data ready to present by June 2018. CONCLUSION: This study will offer an opportunity to verify the feasibility of integrating an eHealth tool that aims to improve the long-term management of breast cancer in a high-risk population by allowing more timely intervention to prevent or rapidly address AET discontinuation. JMIR Publications 2016-11-07 /pmc/articles/PMC5118585/ /pubmed/27821385 http://dx.doi.org/10.2196/resprot.6519 Text en ©Ari Meguerditchian, Robyn Tamblyn, Sarkis Meterissian, Susan Law, Jaroslav Prchal, Nancy Winslade, Donna Stern. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.11.2016. https://creativecommons.org/licenses/by/2.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/ (https://creativecommons.org/licenses/by/2.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Original Paper
Meguerditchian, Ari
Tamblyn, Robyn
Meterissian, Sarkis
Law, Susan
Prchal, Jaroslav
Winslade, Nancy
Stern, Donna
Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study
title Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study
title_full Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study
title_fullStr Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study
title_full_unstemmed Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study
title_short Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study
title_sort adjuvant endocrine therapy in breast cancer: a novel e-health approach in optimizing treatment for seniors (optimum): a two-group controlled comparison pilot study
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5118585/
https://www.ncbi.nlm.nih.gov/pubmed/27821385
http://dx.doi.org/10.2196/resprot.6519
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