At-home Breast Oncology Care Delivered With E-health Solutions

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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At-home Breast Oncology Care Delivered With E-health Solutions The ABODE Study

Conditions
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Patient Engagement, Patient Activation, Patient Reported Outcome Measures

Intervention / Treatment
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* Other: At-home Breast Oncology care Delivered with E-health solutions - ABODE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females (assigned female at birth)* Diagnosed with first, primary invasive BC Must have surgery as their first step in treatment pathway Age≥18 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>The control arm will receive standard treatment. | |
| Experimental: Interventional Arm<br>Individuals within the intervention will receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months. | Other: At-home Breast Oncology care Delivered with E-health solutions - ABODE<br>* The development and implementation of the Breast Cancer Treatment Application (BCTA) will facilitate a secure approach to virtual care for Breast Cancer patients, provide patient specific treatment education and facilitate evaluation of Patient Reported Outcome Measures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective | 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. | At baseline, 6 months and 12 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROM 1: Impact of Events Scale - Revised (IES-R) | Number of participants with PTSD symptoms, such as distress in regards to their Breast Cancer diagnosis and treatment as assessed by IES-R. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The IES-R yields a total score (ranging from 0 to 88); higher scores mean worse symptoms. | At baseline, 6 and 12 months after diagnosis | 
| PROM 2: Generalized Anxiety Disorder (GAD-7) | Number of participant with generalized anxiety around their breast cancer diagnosis and treatment assessed by GAD-7. The GAD-7 is a 7-item scale used to measure or assess the severity of generalized anxiety disorder based on symptoms. | 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) | Number of participants with changes in their physical, psychological and social functions during and after their diagnosis and surgery, assessed by the EORTC QLQ-C30. The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life. | 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) | Number of participants with changes in their quality of life after their breast cancer diagnosis and treatment journey assessed by the EORTC QLQ-BR23. The survey includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. | At baseline, 6-months and 12-months after enrollment | 
| PROM 5: Self-Identification Survey | Number of participants and their reported identities assessed by the 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). | Number of participants and their satisfaction with information provided about treatment received assessed by the EORTC QLQ-INFO25. The provisional 25-item information questionnaire is Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=higher satisfaction with provided treatment information. | 9-months post-diagnosis | 
| PROM 7: The Health Information Questionnaire (heiQ) | Number of participants and how comfortable they are with the patient educational programs provided throughout the patient's treatment journey, assessed by the heiQ at the beginning and 9 months post diagnosis. heiQ is a validated, self-reported instrument with 8 domains to comprehensively evaluate patient education program and self-management intervention. Each domain score ranges from 1 to 4; a higher score indicates better outcome. | At baseline, 9 months post-diagnosis | 
| PROM 8: Clinical Evaluation Questionnaire - INS (CEQ-INS) | Number of participants and their experience of cancer care in teams of their receipt of useful and relevant information about cancer, assistance with service navigation, and support from their care team examined with the CEQ-INS half way and end of the study. CEQ-INS is a self-reported instrument with questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Higher scores correlate with higher patient satisfaction with the information and support provided from their care team. | 6 and 12 months post-diagnosis | 
| PROM 9: Other Health App Questionnaire (OHA) | Number of participants and how frequently they use other e-health applications assessed by the OHA. The OHA is a self reported questionnaire with an array question (yes, no, unsure) regarding the participants involvement with other e-health applications. | 6 and 12 months post-diagnosis | 
| PROM 10: The Duke Activity Status Index (DASI) | Number of participants and their functional capacity evaluated by the DASI at the beginning of the study. The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs) and has been shown to be a valid measurement of functional capacity. | Baseline | 
| PROM 11:The Multidimensional Impact of Cancer Risk Assessment (MICRA) | A 25-item tool use to assess participants and the specific impact of result disclosure after genetic testing. The assessment administers 4 point Likert-type questions (never=0 to often=5) regarding how individuals feel after being told their genetic test results. Distress subscale = Items 1-4, 7 & 8; Uncertainty subscale = Items 9-12, 14-17 & 20; Positive experiences subscale (reverse scored) = Items 5, 6, 18 & 19. Subscales are scored by summing circled numbers | 1 Week Post Genetic Test Results via BCTA | 
| PROM 12: The Knowgene | The number of participants and their general cancer genetic knowledge after cancer genetic counseling and multigene panel testing. | 1 Week Post Genetic Test Results via BCTA | 
| PROM 13: Breast Cancer Treatment Application Review Survey (BCTA) | Patient satisfaction with the app will be measured by utilizing the Breast Cancer Treatment Application Review Survey. The survey will be administered to participants using the application at the 12-month mark, to better understand any barriers to using the app and which aspects were most useful to patients. The 10 item assessment uses 5-point Likert-type questions (strongly disagree to strongly agree) to assess their experience on the application. | 12-months Post-Enrollment | 
| PROM 14: Functional Assessment Of Cancer Therapy-Endocrine Subscale (FACT-ES) Score | Investigators will measure relative changes in adverse symptom burden using the Functional Assessment Of Cancer Therapy-Endocrine Subscale (FACT-ES) questionnaire. The FACT-ES is a 46-item questionnaire asking participants to report how much they have been impacted by a variety of symptoms on a 5-point scale where 0 = not at all and 4 = very much. Total raw scores range from 0 to 184, with higher scores indicating greater impact from symptoms. | 2 to 3 Months Post Start of Endocrine Treatment via Breast Cancer Treatment App | 
| PROM 15: System-Usability Score (SUS) | Usability will be assessed using the System Usability Scale (SUS). We wil collect the input of breast cancer patients to the SUS questions, using in-app surveys and will calculate the SUS score. We will assess overall satisfaction with the app by asking users to provide an answer to the question How likely are you to recommend this product to a friend on a scale of 0-10. | 12-months Post-Enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-Health, m-Health, Mobile Application, Psychosocial Oncology, Survivorship, Breast Cancer