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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576545
• Other study ID #: KMUHIRB-E(I)-20200041
• Status: Completed
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: August 15, 2022

Study information

• Verified date: October 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. In the first phase of this study, develop a prototype the Breast Cancer Self-Care App by conducting patients interviews. In the second phase, an experimental two-group pretest-posttest quantitative study design to evaluate the self-efficacy and resilience of the Breast Cancer Self-Care App in newly diagnosed breast cancer patients undergoing chemotherapy. The patients were randomized to the experimental and control groups. Patients in the control group received general routine care and patients in the experimental group received general routine care plus the Breast Cancer Self-Care App intervention. Both groups completed a basic demographics, self-efficacy and resilience questionnaires at the pre-test and after four weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• DSM-V mentally ill

• IOS system smartphone

• over 65 years old

Related Conditions & MeSH terms

• Breast Cancer
• Breast Malignant Tumor
• Breast Neoplasm
• Breast Neoplasms
• Neoplasms
• Resilience
• Self-efficacy

Intervention

Device:
• The Breast Cancer Self-Care App
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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

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* Note: There are 64 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Resilience	Use Resilience scale 14 items (RS-14) measure individual resilience. The scale with a total of 14 items measures resilience. The range of total scores of the scale is 14-98. It shows that resilience increases as total points of the scale increase.	4 weeks