Breast CancerNCT04174248
Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life
A study testing BCSMS App in people with Breast Cancer and Quality of Life, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Quality of Life
- What is being tested?
- BCSMS App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2019to 6 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- not matched to inclusion criteria
- mental illness
- serious illness and life-threatening
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- BCSMS App
- Keywords
- breast cancer, m-Health application, self-management, life of quality
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCSMS AppOther
Breast Cancer Using a Self-Management Support mHealth Application
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group with BCSMS App using Receives: Other: BCSMS App |
| Control group | No intervention | Control group without BCSMS App using |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: the 3rd month
Secondary outcomes (3)
Baseline EORTC QLQ-BR23
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.
Measured: Baseline
Change of EORTC QLQ-BR23 at 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.
Measured: 1.5 month
Change of EORTC QLQ-BR23 at 3 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.
Measured: the 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start11 Jan 2019
- Primary completion6 Jul 2019
- Study completion6 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Ching Hou, National Yang Ming Chiao Tung University
- Investigators
- ICing Hou, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174248
- Sponsor's protocol ID
- YM107109E
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32130181
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04174248
- Acronym / sponsor ID
- YM107109E
- Conditions
- Breast Cancer, Quality of Life
- Keywords
- breast cancer, m-Health application, self-management, life of quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 6 Jul 2019 (actual)
- Study completion
- 6 Jul 2019 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: BCSMS AppExperimental group with BCSMS App using |
| Control group | No intervention | –Control group without BCSMS App using |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- not matched to inclusion criteria
- mental illness
- serious illness and life-threatening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCSMS AppBreast Cancer Using a Self-Management Support mHealth Application | Other | Experimental group |
Primary outcome
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 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.
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.
3 secondary outcomes
Baseline EORTC QLQ-BR23
Time frame: Baseline
Change of EORTC QLQ-BR23 at 1.5 month
Time frame: 1.5 month
Change of EORTC QLQ-BR23 at 3 month
Time frame: the 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Derived from this study: PubMed 32130181Hou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICing Hou, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCSMS App in people with Breast Cancer and Quality of Life, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline EORTC QLQ-C30 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04174248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.