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Training With Mobile Application in Breast Cancer

The Effect of E-mobile Education on The Quality of Life in Breast Cancer Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04315012
Enrollment
64
Registered
2020-03-19
Start date
2018-01-10
Completion date
2018-04-17
Last updated
2020-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, quality of life, endocrine hormonal therapy, mobile phone, mobil app, education of patients, smartphone

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.

Interventions

OTHERreceive mobile app-based education

to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.

Sponsors

Ege University
CollaboratorOTHER
Izmir Bakircay University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Functional Assessment for the Cancer Treatment - Endocrine Symptoms Quality of Life Scale (FACT-ES QLS)Change from Baseline Quality of Life at 12 weeksThe scale includes five sub dimensions and total of 46 items measuring the well-being of patients within the course of the last 7 days. There are sub dimensions for each of the following: physical well-being (7 items, 0-28 points), social/family well-being (7 items, 0-28 points), emotional well-being (6 items, 0-24 points), functional well-being (7 items, 0-28 points) and endocrine symptoms (19 items, 0-76 points). Endocrine symptoms' subdimension contains symptoms related to the side effects of EHT. The range of total points of the scale is 0-184. It shows that quality of life increases as total points of the scale increase. It shows that quality of life decreases as total points of the scale decrease.
National Comprehensive Cancer Network (NCCN) Distress ThermometerChange from Baseline Distress at 12 weeksPatients may specify the severity of the distress level they experienced related to their problems, with these numbers, within the course of last 7 days. No distress is specified with 0 point, a severe amount of distress is specified with 10 points.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026