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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06949046
Acronym
breast cancer
Enrollment
80
Registered
2025-04-29
Start date
2024-08-01
Completion date
2025-04-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

breast cancer, chemotherapy

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.

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.

Interventions

OTHERnursing-led communication support

nursing-led communication support program using mobile health information

OTHERNursing routine treatment

Nursing routine treatment

Sponsors

National Defense Medical Center, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

breast cancer initial chemotherapy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life (EORTC QLQ-C30)Baseline, 1 month, and 2 months after enrollmentQuality 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

MeasureTime frameDescription
Anxiety and DepressionBaseline, 1 month, and 2 months after enrollmentAnxiety 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026