search
Back to results

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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Using mobile information application about before and after surgery
Sponsored by
Suleyman Demirel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, mobile application, mobile health, anxiety, distress, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Suleyman Demirel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change of NCCN Distress Thermometer score at baseline and one month later
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 Outcome Measures

Change of Hospital Anxiety and Depression Scale score at baseline and one month later
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.).
Change of FACT-G Quality of Life Scale score at baseline and one month later
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.

Full Information

First Posted
April 23, 2022
Last Updated
April 29, 2022
Sponsor
Suleyman Demirel University
search

1. Study Identification

Unique Protocol Identification Number
NCT05360407
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, mobile application, mobile health, anxiety, distress, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Using mobile information application about before and after surgery
Intervention Description
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 Outcome Measure Information:
Title
Change of NCCN Distress Thermometer score at baseline and one month later
Description
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.
Time Frame
The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.
Secondary Outcome Measure Information:
Title
Change of Hospital Anxiety and Depression Scale score at baseline and one month later
Description
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.).
Time Frame
The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.
Title
Change of FACT-G Quality of Life Scale score at baseline and one month later
Description
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.
Time Frame
The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Suleyman Demirel University
City
Isparta
ZIP/Postal Code
32200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
32514909
Citation
Barr K, Hill D, Farrelly A, Pitcher M, White V. Unmet information needs predict anxiety in early survivorship in young women with breast cancer. J Cancer Surviv. 2020 Dec;14(6):826-833. doi: 10.1007/s11764-020-00895-7. Epub 2020 Jun 8.
Results Reference
background
PubMed Identifier
32687476
Citation
Brennan L, Kessie T, Caulfield B. Patient Experiences of Rehabilitation and the Potential for an mHealth System with Biofeedback After Breast Cancer Surgery: Qualitative Study. JMIR Mhealth Uhealth. 2020 Jul 29;8(7):e19721. doi: 10.2196/19721.
Results Reference
background
PubMed Identifier
30587936
Citation
Brett J, Boulton M, Watson E. Development of an e-health app to support women prescribed adjuvant endocrine therapy after treatment for breast cancer. Patient Prefer Adherence. 2018 Dec 11;12:2639-2647. doi: 10.2147/PPA.S187692. eCollection 2018.
Results Reference
background
PubMed Identifier
32405966
Citation
Chan RJ, Howell D, Lustberg MB, Mustian K, Koczwara B, Ng CC, Kim Y, Napoles AM, Dixit N, Klemanski D, Ke Y, Toh YL, Fitch MI, Crichton M, Agarawal S, Chan A. Advances and future directions in the use of mobile health in supportive cancer care: proceedings of the 2019 MASCC Annual Meeting symposium. Support Care Cancer. 2020 Sep;28(9):4059-4067. doi: 10.1007/s00520-020-05513-x. Epub 2020 May 14.
Results Reference
background
PubMed Identifier
31998651
Citation
Chung IY, Jung M, Park YR, Cho D, Chung H, Min YH, Park HJ, Lee M, Lee SB, Chung S, Son BH, Ahn SH, Lee JW. Exercise Promotion and Distress Reduction Using a Mobile App-Based Community in Breast Cancer Survivors. Front Oncol. 2020 Jan 10;9:1505. doi: 10.3389/fonc.2019.01505. eCollection 2019.
Results Reference
background
PubMed Identifier
33882446
Citation
Cinar D, Karadakovan A, Erdogan AP. Effect of mobile phone app-based training on the quality of life for women with breast cancer. Eur J Oncol Nurs. 2021 Jun;52:101960. doi: 10.1016/j.ejon.2021.101960. Epub 2021 Apr 18.
Results Reference
background
PubMed Identifier
32659714
Citation
Comez S, Karayurt O. The effect of web-based training on life quality and spousal adjustment for women with breast cancer and their spouses. Eur J Oncol Nurs. 2020 Aug;47:101758. doi: 10.1016/j.ejon.2020.101758. Epub 2020 Apr 9.
Results Reference
background
PubMed Identifier
27611236
Citation
Foley NM, O'Connell EP, Lehane EA, Livingstone V, Maher B, Kaimkhani S, Cil T, Relihan N, Bennett MW, Redmond HP, Corrigan MA. PATI: Patient accessed tailored information: A pilot study to evaluate the effect on preoperative breast cancer patients of information delivered via a mobile application. Breast. 2016 Dec;30:54-58. doi: 10.1016/j.breast.2016.08.012. Epub 2016 Sep 6.
Results Reference
background
PubMed Identifier
32130181
Citation
Hou IC, Lin HY, Shen SH, Chang KJ, Tai HC, Tsai AJ, Dykes PC. Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 4;8(3):e17084. doi: 10.2196/17084.
Results Reference
background
PubMed Identifier
31119709
Citation
Korkmaz S, Iyigun E, Tastan S. An Evaluation of the Influence of Web-Based Patient Education on the Anxiety and Life Quality of Patients Who Have Undergone Mammaplasty: a Randomized Controlled Study. J Cancer Educ. 2020 Oct;35(5):912-922. doi: 10.1007/s13187-019-01542-1.
Results Reference
background
PubMed Identifier
31008546
Citation
Villarreal-Garza C, Lopez-Martinez EA, Martinez-Cannon BA, Platas A, Castro-Sanchez A, Miaja M, Mohar A, Monroy A, Aguila C, Galvez-Hernandez CL. Medical and information needs among young women with breast cancer in Mexico. Eur J Cancer Care (Engl). 2019 Jul;28(4):e13040. doi: 10.1111/ecc.13040. Epub 2019 Apr 22.
Results Reference
background
PubMed Identifier
22571072
Citation
Wysocki WM, Mitus J, Komorowski AL, Karolewski K. Impact of preoperative information on anxiety and disease-related knowledge in women undergoing mastectomy for breast cancer: a randomized clinical trial. Acta Chir Belg. 2012 Mar-Apr;112(2):111-5. doi: 10.1080/00015458.2012.11680807.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs