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

Not Applicable

Completed

• Conditions: Breast Cancer; Breast Neoplasm; Self-efficacy; Breast Malignant Tumor; Resilience
• Interventions: Device: The Breast Cancer Self-Care App

• Registration Number: NCT05576545
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2020-09-18
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-15
• Study First Submitted: 2022-09-26
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-10
• Last Update Submitted: 2022-10-10
• Study First Posted: 2022-10-12
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general routine care and the Breast Cancer Self-Care App	The Breast Cancer Self-Care App	-

Primary Outcome Measures

Name	Time	Method
Self-efficacy	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Resilience	4 weeks	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.

Trial Locations

Locations (1)

Kaohsiung Medical University; 🇨🇳 Kaohsiung, Taiwan