The Effect of Mobile Application-based Information About Before and After Surgery

April 29, 2022 updated by: Filiz Salman, Suleyman Demirel University

The Effect of Mobile Application-based Information About Before and After Surgery on Anxiety, Distress and Quality of Life of Women With Breast Cancer

Aim and hypothesis: This study was conducted to evaluate the effect of mobile information given to women before and after breast cancer surgery on anxiety, distress, and quality of life. E-mobile information given to women before and after breast cancer surgery reduces the level of anxiety (I) and the level of distress (II), and positively affects their quality of life (III).

Methods: This randomized controlled study was conducted between April and August 2021 in the surgical oncology clinic-outpatient clinics of a university hospital. Patients in the intervention group (n=42) used the mobile information application for one month with routine care. Patients in the control group (n=40) received their routine care. Data were collected with data collection forms one week before and three weeks after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • 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
      • Isparta, Turkey, 32200
        • Suleyman Demirel 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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Scheduled for elective surgery due to breast cancer,
  • Over 18 years old,
  • Read and understand Turkish,
  • At least primary school graduates,
  • Have internet access,
  • Have a smartphone with an android operating system suitable for downloading the mobile application.

Exclusion Criteria:

  • Diagnosed with active psychiatric disease,
  • Using antidepressant medication,
  • Vision problems that prevented them from using the mobile application,
  • Scheduled for reconstructive surgery using their own tissue

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Group
The mobile information application was downloaded from the Android market and installed on the patients' phones, and the patients were taught about how to use it. The patients were given a short information brochure on the use of the mobile application. One week after the surgery, the patients were called and reminded about the use of the application. Three weeks after the surgery, data were collected through telephone interviews using the Patient Follow-up Form, Anxiety, Distress and Quality of Life measurement tools, the Patient Information Satisfaction Questionnaire, and the Mobile Application Evaluation Form.
Other: Using mobile information application about before and after surgery

The mobile application had three sections: Information forum (I), Personal forum (notebook and reminder) (II) and Ask the Researcher (messaging) (III). The information forum (Figure 2) is a section that enables patients to access related articles, pictures, and videos. The personal forum is a section that allows patients to create their notes and use the necessary reminders. Ask the researcher section allows patients to communicate with the researcher via messages.

The participants could download the mobile application with the name "Breast Cancer Surgery Information Guide" from the Google Play Store and install it on their phones. Users who were authenticated by the researcher were able to access the content with an e-mail and password.
NO_INTERVENTION: Control Group
The patients received routine care and training in the clinic, and no additional intervention was applied. Three weeks after the surgery, data were collected through telephone interviews using the Patient Follow-up Form, Anxiety, Distress and Quality of Life measurement tools, and the Patient Information Satisfaction Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of NCCN Distress Thermometer score at baseline and one month later
Time Frame: The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.
This scale was developed by Roth et al. (1998) to measure psycho-social distress in cancer patients. It consists of the visual analog scale that individuals can apply on their own, consists of only one question, and is used to evaluate the stress situations patients have experienced in the last week and a list of problems. There is a thermometer with numbers from 0 to 10 on the scale. On the distress thermometer, a score of 0 indicates that the individual has never experienced distress, and a score of 10 indicates that he or she has experienced distress at the upper limit.
The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Hospital Anxiety and Depression Scale score at baseline and one month later
Time Frame: The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.
The HAD is a self-report scale used to diagnose anxiety and depression in a short time and to determine the risk group in patients with physical illness and/or applying to primary health care services. Only the Anxiety subscale (HAD-A) was used in this study. Anxiety subscale consists of 7 items (1st, 3rd, 5th, 7th, 9th, 11th and 13th questions). Items 1, 3, 5, 11, and 13 show gradually decreasing severity. The score that can be obtained from the HAD-A ranges between 0 and 21 (min.-max.).
The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.
Change of FACT-G Quality of Life Scale score at baseline and one month later
Time Frame: The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.
Functional Assessment of Cancer Therapy-General (version 4) Quality of Life Scale consists of 4 dimensions; physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). There are a total of 27 questions on the scale. The scale has a 5-point Likert-type structure and is scored between 0-4. All questions are used to assess the patients' quality of life in the last 7 days. The total score of the scale is equal to the sum of the sub-dimensions, and a high score on the scale indicates a high quality of life.
The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.

Collaborators and Investigators

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

Sponsor

Suleyman Demirel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2021

Primary Completion (ACTUAL)

August 30, 2021

Study Completion (ACTUAL)

August 30, 2021

Study Registration Dates

First Submitted

April 23, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (ACTUAL)

May 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SuleymanDU-SALMAN-F-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study information will be shared in line with the appropriate requests of researchers via e-mail.

IPD Sharing Time Frame

Study information will be shared in line with the appropriate requests of researchers via e-mail.

IPD Sharing Access Criteria

Study information will be shared in line with the appropriate requests of researchers via e-mail.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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.

Clinical Trials on Breast Cancer

Clinical Trials on Using mobile information application about before and after surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe