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

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Device: CanADVICE+® (smart phone app)

• Registration Number: NCT02580396
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-20
• Study Start: 2016-03-16
• Status Verified: 2018-10
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients eligible for CanADVICE+® (smart phone app)	CanADVICE+® (smart phone app)	-

Primary Outcome Measures

Name	Time	Method
Patient acceptability of the app using questionnaire provided when patients attend for their 3rd cycle and quantified using a 5-point Likert scale	42 days	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

Name	Time	Method
Health care provider's acceptability of the app using questionnaires	48 months	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	42 days	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.

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom