Training With Mobile Application in Breast Cancer

March 29, 2020 updated by: Derya ÇINAR, Izmir Bakircay University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Turkey
      • İzmir, Turkey, 35665
        • İzmir Bakırçay University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Receiving 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.
Other: receive 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.
No Intervention: Standart
not to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Assessment for the Cancer Treatment - Endocrine Symptoms Quality of Life Scale (FACT-ES QLS)
Time Frame: Change from Baseline Quality of Life at 12 weeks
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.
Change from Baseline Quality of Life at 12 weeks
National Comprehensive Cancer Network (NCCN) Distress Thermometer
Time Frame: Change from Baseline Distress at 12 weeks
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.
Change from Baseline Distress at 12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Bakircay University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: DERYA ÇINAR, İzmir Bakırçay University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Bakircay University

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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