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Training With Mobile Application in Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
receive mobile app-based education
Sponsored by
Izmir Bakircay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, quality of life, endocrine hormonal therapy, mobile phone, mobil app, education of patients, smartphone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • İzmir Bakırçay University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Receiving mobile app-based education

Standart

Arm Description

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

not to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.

Outcomes

Primary Outcome Measures

Functional Assessment for the Cancer Treatment - Endocrine Symptoms Quality of Life Scale (FACT-ES QLS)
The 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 Thermometer
Patients 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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2020
Last Updated
March 29, 2020
Sponsor
Izmir Bakircay University
Collaborators
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04315012
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
January 17, 2018 (Actual)
Study Completion Date
April 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay University
Collaborators
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, quality of life, endocrine hormonal therapy, mobile phone, mobil app, education of patients, smartphone

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Receiving mobile app-based education
Arm Type
Experimental
Arm Description
to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.
Arm Title
Standart
Arm Type
No Intervention
Arm Description
not to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.
Intervention Type
Other
Intervention Name(s)
receive mobile app-based education
Intervention Description
to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.
Primary Outcome Measure Information:
Title
Functional Assessment for the Cancer Treatment - Endocrine Symptoms Quality of Life Scale (FACT-ES QLS)
Description
The 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.
Time Frame
Change from Baseline Quality of Life at 12 weeks
Title
National Comprehensive Cancer Network (NCCN) Distress Thermometer
Description
Patients 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.
Time Frame
Change from Baseline Distress at 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DERYA ÇINAR
Organizational Affiliation
İzmir Bakırçay University
Official's Role
Principal Investigator
Facility Information:
Facility Name
İzmir Bakırçay University
City
İzmir
ZIP/Postal Code
35665
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Training With Mobile Application in Breast Cancer

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