NCT06949046

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

October 4, 2024

Last Update Submit

April 21, 2025

Conditions

Keywords

breast cancerchemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

    Used the Quality of life questionnaire test

    1 year

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 program using mobile health information

nursing-led communication

Nursing routine treatment

Nursing routine treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Man Mei Postdoctoral researcher

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
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

November 1, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations