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Completed

NCT Number: NCT04174248

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, 11221, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCSMS App

Other

Breast Cancer Using a Self-Management Support mHealth Application

Primary outcomes

  1. Baseline EORTC QLQ-C30

    Time frame: 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.

  2. Change of EORTC QLQ-C30 at 1.5 month

    Time frame: 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.

  3. Change of EORTC QLQ-C30 at 3 month

    Time frame: 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.

Secondary outcomes

  1. Baseline EORTC QLQ-BR23

    Time frame: 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.

  2. Change of EORTC QLQ-BR23 at 1.5 month

    Time frame: 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.

  3. Change of EORTC QLQ-BR23 at 3 month

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2019
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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