Breast Cancer Early Stage Breast Cancer (Stage 1-3)breast cancerNCT06949046
Effects of a Nursing-led Communication Using Mobile Health Information in Breast Cancer Patients Undergoing Concurrent Chemotherapy
A study testing nursing-led communication support and Nursing routine treatment in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
Breast cancer is the most common malignant tumor among women. Side effects from initial chemotherapy include sleep disorders, anxiety, depression, and reduced quality of life. Mental health distress is also a major issue in cancer care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- nursing-led communication support and Nursing routine treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 1 Apr 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- breast cancer initial chemotherapy
Who cannot join
- Patients whose cancer has recurred without undergoing the first course of chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Nursing-led Communication Support Program Using Mobile Health Information on Physical and Mental Status in Breast Cancer Patients Undergoing Concurrent Chemotherapy: a Randomized Controlled Trial
Breast cancer is the most common malignant tumor among women. Side effects from initial chemotherapy include sleep disorders, anxiety, depression, and reduced quality of life. Mental health distress is also a major issue in cancer care. This study integrates mobile health information with a nurse-led communication support plan, aiming to improve patients' physical and mental outcomes during chemotherapy.
Read the detailed description
The objective of this study is to explore the effects of a nursing-led communication support program using mobile health information on physical and mental state in breast cancer patients undergoing initial chemotherapy.
- Being tested
- nursing-led communication support, Nursing routine treatment
- Keywords
- breast cancer, chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing-led communication supportOther
nursing-led communication support program using mobile health information
Nursing routine treatmentOther
Nursing routine treatment
| Study group | Role | What they receive |
|---|---|---|
| nursing-led communication | Experimental | nursing-led communication support Receives: Other: nursing-led communication support |
| Nursing routine treatment | Placebo comparator | Nursing routine treatment Receives: Other: Nursing routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (EORTC QLQ-C30)
Quality of life was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores were transformed to a 0-100 scale according to the EORTC scoring manual. Higher scores indicate better functioning and global quality of life, whereas higher symptom scores indicate greater symptom burden. Measurements were obtained at baseline, 1 month, and 2 months after enrollment.
Measured: Baseline, 1 month, and 2 months after enrollment
Secondary outcomes (1)
Anxiety and Depression
Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report questionnaire consisting of two 7-item subscales measuring anxiety (HADS-A) and depression (HADS-D). Each subscale is scored from 0 to 21, with higher scores indicating greater anxiety or depressive symptoms.
Measured: Baseline, 1 month, and 2 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Aug 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Man, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949046
- Sponsor's protocol ID
- A202405082
- Other IDs
- A202405082
- Acronym
- breast cancer
- Status last verified
- Nov 2025
- First submitted
- 4 Oct 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Nursing-led Communication Support Program Using Mobile Health Information on Physical and Mental Status in Breast Cancer Patients Undergoing Concurrent Chemotherapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06949046
- Acronym / sponsor ID
- breast cancer / A202405082
- Keywords
- breast cancer, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 29 Apr 2025 (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.
Breast cancer is the most common malignant tumor among women. Side effects from initial chemotherapy include sleep disorders, anxiety, depression, and reduced quality of life. Mental health distress is also a major issue in cancer care. This study integrates mobile health information with a nurse-led communication support plan, aiming to improve patients' physical and mental outcomes during chemotherapy.
Detailed description
The objective of this study is to explore the effects of a nursing-led communication support program using mobile health information on physical and mental state in breast cancer patients undergoing initial chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nursing-led communication | Experimental | Other: nursing-led communication supportnursing-led communication support |
| Nursing routine treatment | Placebo comparator | Other: Nursing routine treatmentNursing routine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- breast cancer initial chemotherapy
Key exclusion criteria (1 listed)
- Patients whose cancer has recurred without undergoing the first course of chemotherapy
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 |
|---|---|---|
| nursing-led communication supportnursing-led communication support program using mobile health information | Other | nursing-led communication |
| Nursing routine treatmentNursing routine treatment | Other | Nursing routine treatment |
Primary outcome
Quality of Life (EORTC QLQ-C30)
Time frame: Baseline, 1 month, and 2 months after enrollment
Quality of life was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores were transformed to a 0-100 scale according to the EORTC scoring manual. Higher scores indicate better functioning and global quality of life, whereas higher symptom scores indicate greater symptom burden. Measurements were obtained at baseline, 1 month, and 2 months after enrollment.
1 secondary outcome
Anxiety and Depression
Time frame: Baseline, 1 month, and 2 months after enrollment
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 1 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nursing-led communication support and Nursing routine treatment in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by National Defense Medical Center, Taiwan 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 1 inclusion and 1 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 1 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
Quality of Life (EORTC QLQ-C30) (time frame: Baseline, 1 month, and 2 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.