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Clinical Trials/NCT05360407
NCT05360407
Completed
Not Applicable

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

Suleyman Demirel University1 site in 1 country82 target enrollmentApril 1, 2021
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Suleyman Demirel University
Enrollment
82
Locations
1
Primary Endpoint
Change of NCCN Distress Thermometer score at baseline and one month later
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
August 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Filiz Salman

Principal Investigator

Suleyman Demirel University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change of FACT-G Quality of Life Scale score at baseline and one month later(The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.)
  • Change of Hospital Anxiety and Depression Scale score at baseline and one month later(The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.)

Study Sites (1)

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