Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06949046

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

Led by National Defense Medical Center, Taiwan · Updated on 2025-04-29

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Breast cancer is the most common malignant tumor among women, and chemotherapy can cause side effects such as sleep problems, anxiety, depression, and lower quality of life. Mental health challenges are a significant concern in cancer care. This research aims to study the effects of a nursing-led communication support program using mobile health information to help improve both physical and mental health in women undergoing initial chemotherapy for breast cancer. Participants will be randomly assigned to one of two groups: one group will receive a nursing-led communication support program that uses mobile health information, while the other group will receive routine nursing treatment. The study is designed as a randomized controlled trial with double masking to evaluate the impact of the communication program during chemotherapy treatment. During the study, researchers will monitor physical and mental health outcomes over the course of one year. Participants' progress will be assessed through various evaluations to understand the program's effects on their wellbeing. The study includes regular follow-up and safety monitoring to support participants throughout their chemotherapy treatment and beyond.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients undergoing initial chemotherapy for breast cancer
  • Age 18 years or older
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of initial chemotherapy

Participants undergo initial chemotherapy for breast cancer while receiving either nursing-led communication support using mobile health information or nursing routine treatment.

Visits according to chemotherapy schedule

Supportive Care Follow-up

Duration - Up to 1 year

Participants are monitored for effects on physical and mental status related to the nursing-led communication support program during and after chemotherapy.

Periodic visits for up to 1 year

Trial Site Locations

Total: 1 location

1

Tri-Service General Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

M

Man Mei Postdoctoral researcher

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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