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NCT Number: NCT05360407

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

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.

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Key information

Conditions

Breast Cancer Anxiety Disorders Breast Diseases Breast Neoplasms Mental Disorders Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Suleyman Demirel University

Isparta, 32200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Using mobile information application about before and after surgery

Other

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.

Primary outcomes

  1. 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

  1. 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.).

  2. 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.

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2022
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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