Clinical trial NCT05360407: The Effect of Mobile Application-based Information About Before and After Surgery
Official title: The Effect of Mobile Application-based Information About Before and After Surgery on Anxiety, Distress and Quality of Life of Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
mobile application
mobile health
anxiety
distress
quality of life
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change of NCCN Distress Thermometer score at baseline and one month later
timeFrame: The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.
Secondary outcomes:
measure: Change of Hospital Anxiety and Depression Scale score at baseline and one month later
timeFrame: The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.
measure: Change of FACT-G Quality of Life Scale score at baseline and one month later
timeFrame: The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
Study officials:
References:
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