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 (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians.


OBJECTIVE
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.


CONCLUSIONS
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.
Clinical and Health Informatics Research Group, McGill University, Montreal, QC, Canada.|Department of Surgery, McGill University, Montreal, QC, Canada.|Department of Oncology, McGill University, Montreal, QC, Canada.|Breast Clinic, McGill University Health Centre, Montreal, QC, Canada.
Ari
http://orcid.org/0000-0003-4798-8135
A
Meguerditchian
Clinical and Health Informatics Research Group, McGill University, Montreal, QC, Canada.|Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.|Department of Medicine, McGill University, Montreal, QC, Canada.
Robyn
http://orcid.org/0000-0003-0134-6954
R
Tamblyn
Department of Surgery, McGill University, Montreal, QC, Canada.|Department of Oncology, McGill University, Montreal, QC, Canada.|Breast Clinic, McGill University Health Centre, Montreal, QC, Canada.
Sarkis
http://orcid.org/0000-0002-9586-3583
S
Meterissian
Department of Family Medicine, McGill University, Montreal, QC, Canada.|Research Centre, St. Mary's Hospital, Montreal, QC, Canada.
Susan
http://orcid.org/0000-0001-5196-2267
S
Law
Department of Oncology, McGill University, Montreal, QC, Canada.|Department of Oncology, St. Mary's Hospital Center, Montreal, QC, Canada.
Jaroslav
http://orcid.org/0000-0002-1185-4365
J
Prchal
Department of Medicine, McGill University, Montreal, QC, Canada.
Nancy
http://orcid.org/0000-0003-4417-3459
N
Winslade
Department of Oncology, St. Mary's Hospital Center, Montreal, QC, Canada.
Donna
http://orcid.org/0000-0002-5956-595X
D
Stern
administrative claims; aromatase inhibitors; breast neoplasms; health care; health services for the aged; medical informatics applications; medication adherence; telemedicine