Evaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine

Study Overview
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Brief Summary
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This feasibility study will be conducted in order to provide proof of concept for the CanADVICE+® system comprising a smart phone app and a healthcare organization server side application based on Web 2 technologies. The main objective of this project is to optimise pharmaceutical counselling services by providing drug related information, in a digital format, to patients with metastatic breast cancer receiving Capecitabine.

Official Title
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Evaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Device: CanADVICE+® (smart phone app)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with metastatic breast cancer Commencing first cycle of Capecitabine Familiar with and own an android smartphone Willing to participate Exclusion Criteria: Patients <18 years Patients taking part in any other trial containing Capecitabine Chemotherapy-naïve patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients eligible for CanADVICE+® (smart phone app)<br> | Device: CanADVICE+® (smart phone app)<br>* The main objective of this project is to optimise pharmaceutical counselling services by providing drug related information, in a digital format, to patients with metastatic breast cancer receiving Capecitabine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptability of the app using questionnaire provided when patients attend for their 3rd cycle and quantified using a 5-point Likert scale | The app will be used at cycles 1 and 2 of capecitabine (each cycle is 21 days), and acceptability of the app will be measured using a questionnaire when patients attend hospital for their 3rd cycle of capecitabine. | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care provider's acceptability of the app using questionnaires | At the end of the study, health care professionals (HCPs) involved in the study will be interviewed using semi-structured interview. | 48 months | 
| Patients' interactivity with the app will be measured using mobile app and web server functions | The app will be used at cycles 1 and 2 of capecitabine (each cycle is 21 days). During this period the number of patient interactions with the mobile app and health care professionals interactions with the web server functions will be recorded. | 42 days |