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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Breast Cancer, Quality of Life

Intervention / Treatment
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* Other: BCSMS App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Experimental group with BCSMS App using | Other: BCSMS App<br>* Breast Cancer Using a Self-Management Support mHealth Application<br>|
| No Intervention: Control group<br>Control group without BCSMS App using | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, m-Health application, self-management, life of quality