Effects of a Nursing-led Communication Using Mobile Health Information in Breast Cancer Patients Undergoing Concurrent Chemotherapy (breast cancer)
June 29, 2026 updated by: Mei Man, National Defense Medical Center, Taiwan
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan
- Tri-Service General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
breast cancer initial chemotherapy
Exclusion Criteria:
Patients whose cancer has recurred without undergoing the first course of chemotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: nursing-led communication
nursing-led communication support
|
nursing-led communication support program using mobile health information
|
|
Placebo Comparator: Nursing routine treatment
|
Nursing routine treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 1 month, and 2 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety and Depression
Time Frame: Baseline, 1 month, and 2 months after enrollment
|
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.
|
Baseline, 1 month, and 2 months after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2024
Primary Completion (Actual)
April 1, 2025
Study Completion (Actual)
April 1, 2025
Study Registration Dates
First Submitted
October 4, 2024
First Submitted That Met QC Criteria
April 21, 2025
First Posted (Actual)
April 29, 2025
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A202405082 (Registry Identifier: Tri-Service General Hospital Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.