Training With Mobile Application in Breast Cancer

NCT04315012 | Completed

• 1 other identifier: Bakircay University
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from Baseline Quality of Life at 12 weeks

• 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.

  Change from Baseline Distress at 12 weeks

Study Arms (2)

Receiving mobile app-based education

EXPERIMENTAL

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

Standart

NO INTERVENTION

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

Interventions

receive mobile app-based education OTHER

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

Receiving mobile app-based education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Bakircay University: lead
• Ege University: collaborator

Study Sites (1)

İzmir Bakırçay University

Izmir, 35665, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• DERYA ÇINAR

  İzmir Bakırçay University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Model Details: 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

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 19, 2020
• Study Start: January 10, 2018
• Primary Completion: January 17, 2018
• Study Completion: April 17, 2018
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)