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Completed

NCT Number: NCT06949046

Effects of a Nursing-led Communication Using Mobile Health Information in Breast Cancer Patients Undergoing Concurrent Chemotherapy

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.

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Key information

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

breast cancer initial chemotherapy

Exclusion criteria

Patients whose cancer has recurred without undergoing the first course of chemotherapy

Treatment and study plan

nursing-led communication support

Other

nursing-led communication support program using mobile health information

Nursing routine treatment

Other

Nursing routine treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study 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

Acronym: breast cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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