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

NCT ID: NCT04174248

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2019-07-06

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.

Conditions

Breast Cancer; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Experimental group with BCSMS App using

Group Type: EXPERIMENTAL

BCSMS App

Intervention Type: OTHER

Breast Cancer Using a Self-Management Support mHealth Application

Control group

Control group without BCSMS App using

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BCSMS App

Breast Cancer Using a Self-Management Support mHealth Application

Intervention Type: OTHER

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.

• mental illness
• serious illness and life-threatening

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

I-Ching Hou

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ICing Hou, PhD

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

Locations

National Yang-Ming University

Taipei, , Taiwan

Countries

Taiwan

References

Hou IC, Lin HY, Shen SH, Chang KJ, Tai HC, Tsai AJ, Dykes PC. Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 4;8(3):e17084. doi: 10.2196/17084.

Reference Type: DERIVED

PMID: 32130181 (View on PubMed)

Other Identifiers

YM107109E

Identifier Type: -

Identifier Source: org_study_id