Mobile Application Support for Women With Breast Cancer Undergoing Chemotherapy

March 14, 2023 updated by: Cheng-Hsin General Hospital

The Effectiveness of a Mobile Application as a Support Tool for the Treatment of Women With Breast Cancer Undergoing Chemotherapy: A Randomized Controlled Trial

Mobile phones have become an essential tool for everyday life. The convenience and easy accessibility of the data and information received through mobile phones have made mobile applications as the latest trend to provide education for patients in medical centers. In Taiwan, breast cancer incidence has been the highest among all cancers and the fourth leading cause of cancer deaths in women. Women with breast cancer who are undergoing chemotherapy suffer from a number of symptoms throughout the chemotherapy treatment that detrimentally affects their quality of life. Thus, providing social support and nursing care aids for these vulnerable women is imperative to help them face their breast cancer challenges. This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers. This study will use a mixed-methods design to develop a Mobile device application based on breast cancer literature and the clinical experiences of breast cancer patients to fulfill the needs women may experience during the chemotherapy treatment. Women with breast cancer will be invited to help refine the Mobile device application's content based on their experiences and feedback about the mobile application. Upon completing the mobile application development, women with breast cancer patients will be recruited to participate in a randomized controlled trial to examine the effectiveness of the mobile application. The results of this study will provide a foundation to deliver a remote, personalized, and continuous health care model to improve the self-efficacy, social support, and quality of life of women with breast cancer, and ultimately enhancing the overall quality of care and patient satisfaction with the medical care participants receive.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This application has four modules: 1) a Learning forum; 2) a Ask-the-Expert forum; 3) a Website link forum; 4) a Encouragement forum. The intervention group will receive routine care plus access to the "B with you" program during their six cycles of chemotherapy. Self-efficacy, social support, and quality of life will be measured at baseline, then the 3rd and 6th cycles of chemotherapy.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Cheng Hsin General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • at least 20 years of age.
  • diagnosed with breast cancer for the first time.
  • treated with chemotherapy at the study sites.
  • able to access the internet with a mobile phone.
  • Fluent in spoken and written Chinese .

Exclusion Criteria:

  • patients with cognitive dysfunction.
  • diagnosed mental health problems.
  • having with other cancers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile device application group
routine care and mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment
Device: Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapy
This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers.
No Intervention: control group
routine care for breast cancer women during their chemotherapy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the baseline score of the Symptom-Management Self-Efficacy Scale-Breast Cancer, SMSES-BC at the third chemotherapy (T1) and the sixth chemotherapy (T2).
Time Frame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
The SMSES-BC scale is a 27-question tool used to assess the self-confidence level of the symptom self-care process of women with breast cancer when participants have side effects and other related symptoms during chemotherapy. There are three parts: seeking problem-solving and related resources (7 questions), dealing with symptoms related to chemotherapy (15 questions), and dealing with emotions and interpersonal troubles (5 questions). The Likert scale method is used to score. 0 points mean very unconfident, 10 points mean very confident, and the score ranges from 0 to 270 points. The higher score obtained according to the scale, the more confident of symptom management during chemotherapy among the women with breast cancer
Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
Change from the baseline score of the Social Support Scale at the third chemotherapy (T1) and the sixth chemotherapy (T2).
Time Frame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
The Social Support Scale is concerned with ways in which others affect persons' responses to stressful events. In the Social Support Scale, there is16 questions. The social support scale is divided into spouses, relatives and friends, and medical staff. The four social support functions it covers include: emotional support (questions 1-4), information support (questions 5-8), substantive support (questions 9-12), and evaluative support (13-16 questions); based on the subjective perception of the patient, the degree of support from spouses, relatives and friends, and medical staff is measured. The score is based on the Likert five-point method. The total score ranges from 16 to 80 points. The higher the score, the higher the degree of social support.
Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
Change from the baseline score of the Functional Assessment of Cancer Therapy - Breast, FACT-B at the third chemotherapy (T1) and the sixth chemotherapy (T2).
Time Frame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
The quality of life variables in this study will use the Functional Assessment of Cancer Therapy-Breast (FACT-B), a measurement tool for breast cancer patients' health-related quality of life. It can be used to understand the quality of life of breast cancer patients in the past week. There are 37 questions in total, divided into five aspects, including: physical health (7 questions), social/family health (7 questions), emotional health (6 questions), functional health (7 questions), and additional concerns ( 10 questions). The Likert five-point method is used for scoring (0-not at all, 1-a little, 2-some, 3-equivalent, and 4-very). The score range is 0-148 points, based on each score of the respondent's self-evaluation. The higher the total score, the better the quality of life of breast cancer patients.
Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The User Version of the Mobile Application Rating Scale, uMARS
Time Frame: Data will be collected at the sixth chemotherapy.
The Mobile Application Rating Scale-User version is a simple and reliable quality assessment tool for health-related mobile applications. There are a total of 26 questions on the scale, using a 5-point scoring method (1-Insufficient, 2-Poor, 3-Acceptable, 4-Good, 5-Excellent), in order to adapt to the different situations of each mobile application. There is also an option of "not applicable" for one question. Divided into four objective quality aspects-participation (5 questions), functionality (4 questions), aesthetics (3 questions), information quality (4 questions), a subjective quality facet (4 questions) and a The impact of healthy behavior (6 questions), there are a total of 6 dimensions. The score is presented by the average score of each quality dimension and the total scale, the highest is 5 points, and the lowest is 1 point. The higher the average score, the better the quality.
Data will be collected at the sixth chemotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cheng-Hsin General Hospital

Investigators

  • Principal Investigator: Ya-Hui Liang, BS, Cheng-Hsin General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (818)109A-57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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