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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580396
• Other study ID #: CCR4404
• Status: Completed
• Phase: N/A
• Start date: March 16, 2016
• Est. completion date: November 1, 2018

Study information

• Verified date: October 2018
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Device:
• CanADVICE+® (smart phone app)
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.

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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