Adjuvant Endocrine Therapy in Breast Therapy in Breast Cancer: A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Proportion of patients discontinuing adjuvant endocrine therapy treatment
研究概览
简要总结
Background: In women with hormone receptor positive (HR+) 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 e-health tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians.
详细描述
Objectives: 1) To determine the effectiveness of a patient-specific, real-time e-health alerts delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation. 2) To assess integration of e-health alerts regarding deviations from best practices in administration of AET by cancer care teams.
Methods: A prospective, two group controlled comparison pilot study will be conducted at two 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. Healthcare professionals at the intervention site will have access to the e-health tool which will report to them in real-time: medical events with known associations to AET discontinuation, AET adherence monitor, and a discontinuation alert.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be ≥ 65 years old,
- •Have been diagnosed with incident (non-metastatic) breast cancer,
- •Have a histologically-confirmed breast adenocarcinoma,
- •Have undergone breast surgery for stages I-III disease,
- •Have medical insurance with the Régie de l'Assurance Maladie du Québec (RAMQ) for at least 1 year prior to surgery,
- •Have HR positive disease,
- •Have no history of AET use prior to the diagnosis of breast cancer,
- •Expected to initiate AET or have only recently initiated AET (<6 months) but are free of previous discontinuation events,
- •Have the ability to consent for herself.
排除标准
- •male gender
结局指标
主要结局
Proportion of patients discontinuing adjuvant endocrine therapy treatment
时间窗: 1.5 years
In each trial arm, the proportion of patients discontinuing AET treatment will be calculated as the number of patients discontinuing AET treatment divided by the total number of patients in that trial arm.
次要结局
- Cancer Care Team Actions in the intervention arm - arrange for return to clinic with doctor(1.5 years)
- Cancer Care Team Actions in the intervention arm - referral to doctor for closer follow-up(1.5 years)
- Primary Non-adherence(1.5 years)
- Medical Possession Ratio ≥80%(1.5 years)
- Cancer Care Team Actions in the intervention arm - no changes in usual treatment despite new information provided(1.5 years)
- Cancer Care Team Actions in the intervention arm - Other(1.5 years)
- Mean time to adjuvant endocrine therapy treatment re-initiation.(1.5 years)
- Cancer Care Team Actions in the intervention arm - perform telephone follow-up with patient(1.5 years)
- Cancer Care Team Actions in the intervention arm - perform telephone follow-up with community pharmacist(1.5 years)
- Proportion of patients re-initiating after a discontinuation of adjuvant endocrine therapy treatment(1.5 years)
- Cancer Care Team Actions in the intervention arm - arrange for return to clinic with nurse(1.5 years)
- Cancer Care Team Actions in the intervention arm - ignore the alert(1.5 years)
- Cancer Care Team Actions in the intervention arm - referral to cancer nurse for closer follow-up(1.5 years)
研究者
Ari Meguerditchian
Surgical Oncologist, McGill University Health Centre
McGill University Health Centre/Research Institute of the McGill University Health Centre