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Clinical Trials/NCT04174248
NCT04174248
Completed
Not Applicable

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.

National Yang Ming Chiao Tung University1 site in 1 country112 target enrollmentJanuary 11, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
National Yang Ming Chiao Tung University
Enrollment
112
Locations
1
Primary Endpoint
Baseline EORTC QLQ-C30
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 11, 2019
End Date
July 6, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

I-Ching Hou

Assistant Professor

National Yang Ming Chiao Tung University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Baseline EORTC QLQ-BR23(Baseline)
  • Change of EORTC QLQ-BR23 at 1.5 month(1.5 month)
  • Change of EORTC QLQ-BR23 at 3 month(the 3rd month)

Study Sites (1)

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