CClinicalTrials.gg
CompletedNCT05576545Updated Oct 12, 2022

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

An interventional study of The Breast Cancer Self-Care App in Breast Cancer, Breast Neoplasm and Breast Malignant Tumor, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Sep 2020, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Breast cancer
  • mobile application
  • Resilience
  • self-efficacy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 73 is close to the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • DSM-V mentally ill
  • IOS system smartphone
  • over 65 years old
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    general routine care and the Breast Cancer Self-Care App

    Device: The Breast Cancer Self-Care App

  • No intervention
    general routine care

Interventions

  • DeviceThe 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.

06

What researchers measure

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.

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

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Study locations

1 site
  • Kaohsiung Medical University
    Kaohsiung, 807, Taiwan
08

References and documents

Publications

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Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05576545
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Hsin-Tien Hsu (Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital) — Principal investigator
First posted
Oct 12, 2022
Start date
Sep 18, 2020
Primary completion
Aug 15, 2022
Completion
Aug 15, 2022
Last update
Oct 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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