Develop and Evaluate the Effectiveness of a Self-Care Smartphone Application on the Self-Efficacy, and Resilience Among Newly Diagnosed Breast Cancer Patients Undergoing Treatment

NCT05576545 | Completed

• 1 other identifier: KMUHIRB-E(I)-20200041
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This study was to develop and evaluate the self-efficacy and resilience of the Breast Cancer Self-Care App in newly diagnosed breast cancer patients undergoing chemotherapy.

Conditions

Breast Cancer; Breast Neoplasm; Breast Malignant Tumor; Resilience; Self-efficacy

Keywords

Breast cancer; mobile application; Resilience; self-efficacy

Outcome Measures

Primary Outcomes (1)

• Self-efficacy

  Use Strategies Used by People to Promote Health (SUPPH) measure self-care self-efficacy. The scale total of 29 items measure self-care self-efficacy. There are 3 sub subscales for each of the following: Stress Reduction (10 items, 5-50scores), Making Decisions (3 items, 3-15scores), Positive Attitude (16 items,16-80 scores). The range of total scores of the scale is 29-145. It shows that self-care self-efficacy increases as total points of the scale increase.

  4 weeks

Secondary Outcomes (1)

• Resilience

  4 weeks

Study Arms (2)

general routine care and the Breast Cancer Self-Care App

EXPERIMENTAL

Device: The Breast Cancer Self-Care App

general routine care

NO INTERVENTION

Interventions

The Breast Cancer Self-Care App DEVICE

The Breast Cancer Self-Care App includes several parts- introduction to breast cancer, types of treatment, side effects care, nutrition, relaxation videos, insurance, medical news and recording side effects, etc. The researcher assisted in installing the App on the patient's mobile phone, entered the personal account, and asked the patient to fill in questionnaires. Patients were given individual health education task in the Breast Cancer Self-Care App every week according to the type of chemotherapy drugs. After four weeks, they filled in questionnaires again.

general routine care and the Breast Cancer Self-Care App

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consciousness clear, over 20 years old, can communicate in Mandarin and Taiwanese
• Diagnosed Breast Cancer I-III stage
• undergo first chemotherapy
• Have a smartphone
• Receiving treatment: EC/ EC+T/LC/LC+T E: (Epirubicin)、C: (Cyclophosphamide)、L: (Lipo-Dox)、T: (Taxotere)

You may not qualify if:

• DSM-V mentally ill
• IOS system smartphone
• over 65 years old

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

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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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 12, 2022
• Study Start: September 18, 2020
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)