Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life

Breast Cancer Clinical Trial

Official title:

The Evaluation of Intelligence Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life for Newly Diagnosed Non-metastatic Breast Cancer Women: Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174248
• Other study ID #: YM107109E
• Status: Completed
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: July 6, 2019

Study information

• Verified date: November 2019
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to investigate the quality of life (QoL) for women with breast cancer in Taiwan after using the BCSMS App.

Description:

After receiving their first diagnosis of breast cancer, women with stage 0 to III were randomized into intervention and control groups. Intervention group subjects used BCSMS App and the control group subjects received usual care. Two questionnaires: EORTC QLQ-C30 and EORTC QLQ-BR 23 were distributed to subjects in both arms at baseline and at 1.5 and 3 months. All evaluations were anonymous.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 6, 2019
• Est. primary completion date: July 6, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• first diagnosis of breast cancer with stage 0 to III in past year.

• aged 20 to 65 years

• had an Android/iOS smartphone;

• able to read and write in Chinese;

• willing to participate in the study and provide informed consent.

Exclusion Criteria:

• not matched to inclusion criteria

• mental illness

• serious illness and life-threatening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life

Intervention

Other:
• BCSMS App
Breast Cancer Using a Self-Management Support mHealth Application

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline EORTC QLQ-C30	Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.	Baseline
Primary	Change of EORTC QLQ-C30 at 1.5 month	Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3) to 1.5 month.The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.	1.5 month
Primary	Change of EORTC QLQ-C30 at 3 month	Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3) to the 3rd month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.	the 3rd month
Secondary	Baseline EORTC QLQ-BR23	Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Breast 23 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.	Baseline
Secondary	Change of EORTC QLQ-BR23 at 1.5 month	Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Breast 23 (version 3) to 1.5 month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.	1.5 month
Secondary	Change of EORTC QLQ-BR23 at 3 month	Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Breast 23 (version 3) to the 3rd month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.	the 3rd month