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

Sponsor

National Yang Ming University (Other)

Overall Status

Completed

CT.gov ID

NCT04174248

Collaborator

(none)

112

Enrollment

Location

Arms

5.8

Actual Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Quality of Life	Other: BCSMS App	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official 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.

Actual Study Start Date :

Jan 11, 2019

Actual Primary Completion Date :

Jul 6, 2019

Actual Study Completion Date :

Jul 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Experimental group with BCSMS App using	Other: BCSMS App Breast Cancer Using a Self-Management Support mHealth Application
No Intervention: Control group Control group without BCSMS App using

Arm

Intervention/Treatment

Experimental: Experimental group

Experimental group with BCSMS App using

Other: BCSMS App

Breast Cancer Using a Self-Management Support mHealth Application

No Intervention: Control group

Control group without BCSMS App using

Outcome Measures

Primary Outcome Measures

Baseline EORTC QLQ-C30 [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 1.5 month [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.
Change of EORTC QLQ-C30 at 3 month [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 Outcome Measures

Baseline EORTC QLQ-BR23 [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.
Change of EORTC QLQ-BR23 at 1.5 month [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.
Change of EORTC QLQ-BR23 at 3 month [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Yang-Ming University	Taipei		Taiwan	11221

Sponsors and Collaborators

National Yang Ming University

Investigators

Principal Investigator: ICing Hou, PhD, National Yang Ming University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

I-Ching Hou, Assistant Professor, National Yang Ming University

ClinicalTrials.gov Identifier:

NCT04174248

Other Study ID Numbers:

YM107109E

First Posted:

Nov 22, 2019

Last Update Posted:

Nov 22, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by I-Ching Hou, Assistant Professor, National Yang Ming University

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 22, 2019