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

NCT06949046 | Completed

• 1 other identifier: A202405082
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. This study integrates mobile health information with a nurse-led communication support plan, aiming to improve patients' physical and mental outcomes during chemotherapy.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

breast cancer; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month, and 2 months after enrollment

Secondary Outcomes (1)

• Anxiety and Depression

  Baseline, 1 month, and 2 months after enrollment

Study Arms (2)

nursing-led communication

EXPERIMENTAL

nursing-led communication support

Other: nursing-led communication support

Nursing routine treatment

PLACEBO COMPARATOR

Nursing routine treatment

Other: Nursing routine treatment

Interventions

nursing-led communication support OTHER

nursing-led communication support program using mobile health information

nursing-led communication

Nursing routine treatment OTHER

Nursing routine treatment

Nursing routine treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• breast cancer initial chemotherapy

You may not qualify if:

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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: April 29, 2025
• Study Start: August 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 1, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)