Evaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine
1 other identifier
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedStudy Start
First participant enrolled
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedNovember 2, 2018
October 1, 2018
2.6 years
September 18, 2015
November 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Health care provider's acceptability of the app using questionnaires
48 months
Patients' interactivity with the app will be measured using mobile app and web server functions
42 days
Study Arms (1)
Patients eligible for CanADVICE+® (smart phone app)
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with metastatic breast cancer
- Commencing first cycle of Capecitabine
- Familiar with and own an android smartphone
- Willing to participate
You may not qualify if:
- Patients \<18 years
- Patients taking part in any other trial containing Capecitabine
- Chemotherapy-naïve patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jillian Noble
Royal Marsden NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2015
First Posted
October 20, 2015
Study Start
March 16, 2016
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
November 2, 2018
Record last verified: 2018-10