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

National Yang Ming Chiao Tung University112 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

112

Conditions

Breast Cancer Quality of Life

Interventions

BCSMS AppOTHER

Breast Cancer Using a Self-Management Support mHealth Application

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

National Yang-Ming University

Taipei, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: the 3rd month

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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