Clinical trial NCT05072197: Mobile Application Support for Women With Breast Cancer Undergoing Chemotherapy
Official title: The Effectiveness of a Mobile Application as a Support Tool for the Treatment of Women With Breast Cancer Undergoing Chemotherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: breast cancer
mobile applications
self-efficacy
social support
quality of life
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
measure: Change from the baseline score of the Social Support Scale at the third chemotherapy (T1) and the sixth chemotherapy (T2).
timeFrame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
measure: 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).
timeFrame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
Secondary outcomes:
measure: The User Version of the Mobile Application Rating Scale, uMARS
timeFrame: Data will be collected at the sixth chemotherapy.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
Study officials:
affiliation: Cheng-Hsin General Hospital
name: Ya-Hui Liang, BS
role: PRINCIPAL_INVESTIGATOR
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