Clinical trial NCT04315012: Training With Mobile Application in Breast Cancer
Official title: The Effect of E-mobile Education on The Quality of Life in Breast Cancer Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
quality of life
endocrine hormonal therapy
mobile phone
mobil app
education of patients
smartphone
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2020-03-19
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The data were collected to with face to face and/or telephone interviews at 2 time points: prior to the initiation (T0) and after the completion (T1) of mobile app-based education. Mobile application was including information about breast cancer definition, treatment process, symptoms management, adequate nutrition, regular physical activity and coping with stress. In this process, the control group patients were provided with standard care
Primary purpose: SUPPORTIVE_CARE

Brief summary: Endocrine hormonal therapy (EHT) applied to avoid recurrence and metastasis of the breast cancer has also side effects which do not threaten life; however, it does negatively effects quality of life. The objective of this study was to determine the effects on quality of life of a mobile app-based (e-mobile) education for supportive care of patients with breast cancer receiving adjuvant endocrine hormonal therapy. The data were collected to with face to face and/or telephone interviews at 2 time points: prior to the initiation (T0) and after the completion (T1) of mobile app-based education. Patients were received education via mobile app for 12 weeks during which they were contacted in every 15 days; a mobile app-based (e-mobile) education was provided, including information about breast cancer definition, treatment process, symptoms management, adequate nutrition, regular physical activity and coping with stress. In this process, the control group patients were provided with standard care.

Detailed description: Mobile devices have an increasing role for the patient care and its use in the field of oncology creates promising opportunities for supportive cancer care and patient education. Mobile applications were established for the supportive cancer care but their area of use is limited. Although there are many field specific medical mobile applications, there are few training programs for the benefit of patients. However, these are innovative tools and provide accessibility, individual training and consultancy in order for the patients to be able to cope with side effects of the treatment; thus, improving their quality of life, symptom management and distress.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary breast cancer,
* Non-metastatic,
* Hormone receptor positive (ER positive and/or PR positive)
* For whom adjuvant EHT was implemented at least for three months

Exclusion Criteria:

* Diagnosed with secondary breast cancer,
* Metastatic,
* Hormone receptor negative (ER negative and/or PR negative)

Primary outcomes:
measure: Functional Assessment for the Cancer Treatment - Endocrine Symptoms Quality of Life Scale (FACT-ES QLS)
timeFrame: Change from Baseline Quality of Life at 12 weeks
measure: National Comprehensive Cancer Network (NCCN) Distress Thermometer
timeFrame: Change from Baseline Distress at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Bakırçay University
Study officials:
affiliation: İzmir Bakırçay University
name: DERYA ÇINAR
role: PRINCIPAL_INVESTIGATOR
References: