Back to resultsEvaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine
Primary Purpose
Metastatic Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CanADVICE+® (smart phone app)
Sponsored by
About this trial
This is an interventional other trial for Metastatic Breast Cancer
Eligibility Criteria
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
Sites / Locations
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients eligible for CanADVICE+® (smart phone app)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02580396
First Posted
September 18, 2015
Last Updated
November 1, 2018
Sponsor
Royal Marsden NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02580396
Brief Title
Evaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine
Official Title
Evaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 16, 2016 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients eligible for CanADVICE+® (smart phone app)
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
CanADVICE+® (smart phone app)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient acceptability of the app using questionnaire provided when patients attend for their 3rd cycle and quantified using a 5-point Likert scale
Description
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.
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Health care provider's acceptability of the app using questionnaires
Description
At the end of the study, health care professionals (HCPs) involved in the study will be interviewed using semi-structured interview.
Time Frame
48 months
Title
Patients' interactivity with the app will be measured using mobile app and web server functions
Description
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.
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jillian Noble
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluation Of CanADVICE+®M-Health System To Support Breast Cancer Patients Receiving Capecitabine
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