At-home Breast Oncology Care Delivered With E-health Solutions The ABODE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Primary Objective
研究概览
简要总结
The COVID-19 pandemic has significantly impacted healthcare service delivery, highlighting the need for high quality virtual patient care. Our team has developed a multi-dimensional remote eHealth solution for newly diagnosed breast cancer patients and their practitioners to use during the diagnostic and follow-up period. The ABODE study involved development of a Breast Cancer Treatment Application (app) which will facilitate virtual consultations, deliver patient education material, and collect patient reported outcome measures (PROMs). Using a randomized controlled trial design, the team will evaluate a variety of outcomes for breast cancer patients who will use the app throughout their diagnosis and treatment period.
Primary Objective: To compare changes in patient activation (assessed by PAM-13) over 1 year among newly diagnosed breast cancer patients between those using the app and those receiving standard care.
Secondary Objectives:
- Compare additional PROMs between the standard care and intervention groups
- Describe health service outcomes among app users
- Explore end-user experience of using the app
- Measure activity levels using wearable devices
详细描述
To measure the effect of the app compared to the standard care approach, the study team will conduct a randomized controlled trial of 200 newly diagnosed breast cancer patients seen at a tertiary care cancer centre in Ontario, Canada. The intervention group (n=100) will receive access to the app in addition to standard care for 13 months following their diagnosis. The control group (n=100) will have standard care. Both arms will be provided with a Fitbit wearable device.
The PAM-13 scale assesses patient activation, defined as the knowledge and confidence a patient has in self- management of one's health. Research team will test whether use of the app improves PAM-13 scores at the 12-month follow-up.
Additionally, secondary outcomes will be assessed with data from additional patient-reported outcome measures (PROMs), chart review, hospital administrative databases, and Fitbits. All participants will complete PROMs at baseline, 6- and 12- months post diagnosis via REDCap survey links sent through email. The intervention group will have access to the app for 13 months following randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
After randomization patients will be told what experimental arm they are in.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females (assigned female at birth)*
- •Diagnosed with first, primary invasive BC
- •Must have surgery as their first step in treatment pathway
- •Access to an electronic device with connection to the internet
- •A valid email address
- •Can communicate in English *Since BC risk is sex-related and based on physiological values, our inclusion criteria are based on sex (not gender)
- •Exclusion criteria:
- •Males (assigned male at birth), as BC surgical treatment options and experiences are different
- •Diagnosed with non-operable breast cancer
- •Stage 4/metastatic (whether determined at diagnosis or during surgery)
- •Those with hearing or visual challenges
- •Neo-adjuvant chemotherapy
- •Should not be enrolled in any other UHN study using an e-Health application
- •Breast cancer surgery is scheduled for less 5 business days after enrollment
排除标准
- 未提供
结局指标
主要结局
Primary Objective
时间窗: At baseline, 6 months and 12 months after enrollment
To compare changes in patient activation (assessed by Patient Activation Measure -13) over 1 year among newly diagnosed breast cancer patients between those using the Breast Cancer Treatment Application (BCTA) and those receiving standard care. Difference in Patient Activation Measure (PAM) scores between pre/post intervention. PAM includes 13 questions, each with 4 response options, summed on a 0-100 scale, with higher scores indicating higher activation level. Patient activation is defined as the knowledge, skills, and confidence a person has in managing their health and care. Studies have shown that higher patient activation is associated with improved health related quality of life (HRQoL) and lower health care utilization.
次要结局
- PROM 1: Impact of Events Scale - Revised (IES-R)(At baseline, 6 and 12 months after diagnosis)
- PROM 2: Generalized Anxiety Disorder (GAD-7)(At baseline, 6 and 12 months after diagnosis)
- PROM 3: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)(At baseline, 6-months and 12-months post-diagnosis)
- PROM 4: European Organisation for Research and Treatment of Cancer - Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)(At baseline, 6-months and 12-months after enrollment)
- PROM 5: Self-Identification Survey(At baseline)
- PROM 6: European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire INFO 25 (EORTC QLQ-INFO 25).(9-months post-diagnosis)
- PROM 7: The Health Information Questionnaire (heiQ)(At baseline, 9 months post-diagnosis)
- PROM 8: Clinical Evaluation Questionnaire - INS (CEQ-INS)(6 and 12 months post-diagnosis)
- PROM 9: Other Health App Questionnaire (OHA)(6 and 12 months post-diagnosis)
- PROM 10: The Duke Activity Status Index (DASI)(Baseline)
- PROM 11:The Multidimensional Impact of Cancer Risk Assessment (MICRA)(1 Week Post Genetic Test Results via BCTA)
- PROM 12: The Knowgene(1 Week Post Genetic Test Results via BCTA)
- PROM 13: Breast Cancer Treatment Application Review Survey (BCTA)(12-months Post-Enrollment)
- PROM 14: Functional Assessment Of Cancer Therapy-Endocrine Subscale (FACT-ES) Score(2 to 3 Months Post Start of Endocrine Treatment via Breast Cancer Treatment App)
- PROM 15: System-Usability Score (SUS)(12-months Post-Enrollment)
- PROM 16: Distress Thermometer(At baseline, 6 months and 12 months after enrollment)
- PROM 17: Post Operative Questionnaires(1 to 10 days after surgery)
- Visits to the Breast Clinic(3, 9 and 15 months after enrollment)
- Phone Calls and Emails to the Breast Clinic(3, 6, and 15 months after enrollment)
- Emergency Department Visits(15 months post enrollment)
- Unplanned Hospital Admissions(15 months post enrollment)
- Outpatient Clinic Visits(15 months post enrollment)
- Physical Activity Level (Steps per Day)(13 months after enrollment (whole duration of the study))
- Exercise Heart Rate(13 months after enrollment (whole duration of the study))
- Sleep Duration(13 months after enrollment (whole duration of the study))
- Hospital Admissions(15 months post enrollment)
- Length of Hospital Stay(15 months post enrollment)
- Discharge Outcomes(15 months post enrollment)
- Post-Surgical Complications(15 months post enrollment)
- Wait Times(15 months post enrolment)