NCT04174248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

November 19, 2019

Last Update Submit

November 20, 2019

Conditions

Breast CancerQuality of Life

Keywords

breast cancerm-Health applicationself-managementlife of quality

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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 Arms (2)

Experimental group

EXPERIMENTAL

Experimental group with BCSMS App using

Other: BCSMS App

Control group

NO INTERVENTION

Control group without BCSMS App using

Interventions

BCSMS AppOTHER

Breast Cancer Using a Self-Management Support mHealth Application

Experimental group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • mental illness
  • serious illness and life-threatening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 11221, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 32130181DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • ICing Hou, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 22, 2019

Study Start

January 11, 2019

Primary Completion

July 6, 2019

Study Completion

July 6, 2019

Last Updated

November 22, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)