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

Not Applicable

Completed

• Conditions: Breast Cancer; Quality of Life
• Interventions: Other: BCSMS App

• Registration Number: NCT04174248
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-11
• Primary Completion: 2019-07-06
• Study Completion: 2019-07-06
• Status Verified: 2019-11
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Study First Posted: 2019-11-22
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	BCSMS App	Experimental group with BCSMS App using

Primary Outcome Measures

Name	Time	Method
Baseline EORTC QLQ-C30	Baseline	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.
Change of EORTC QLQ-C30 at 3 month	the 3rd 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.
Change of EORTC QLQ-C30 at 1.5 month	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.

Secondary Outcome Measures

Name	Time	Method
Baseline EORTC QLQ-BR23	Baseline	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.
Change of EORTC QLQ-BR23 at 1.5 month	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.
Change of EORTC QLQ-BR23 at 3 month	the 3rd 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.

Trial Locations

Locations (1)

National Yang-Ming University; 🇨🇳 Taipei, Taiwan