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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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05576545
Collaborator
(none)
73
Enrollment
1
Location
2
Arms
22.9
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: The Breast Cancer Self-Care App
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
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
Actual Study Start Date :
Sep 18, 2020
Actual Primary Completion Date :
Aug 15, 2022
Actual Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: general routine care and the Breast Cancer Self-Care App

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.
No Intervention: general routine care

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaohsiung Medical University Kaohsiung Taiwan 807

Sponsors and Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hsin-Tien Hsu, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05576545
Other Study ID Numbers:
  • KMUHIRB-E(I)-20200041
First Posted:
Oct 12, 2022
Last Update Posted:
Oct 12, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hsin-Tien Hsu, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
Breast cancer
mobile application
Resilience
self-efficacy
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Oct 12, 2022