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

NCT05360407 | Completed

• 1 other identifier: SuleymanDU-SALMAN-F-001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; mobile application; mobile health; anxiety; distress; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  The first measurement was collected one week before surgery. The second measurement was collected 3 weeks after surgery.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, 32200, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 32514909 BACKGROUND

• 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.

  PMID: 32687476 BACKGROUND

• 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.

  PMID: 30587936 BACKGROUND

• 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.

  PMID: 32405966 BACKGROUND

• 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.

  PMID: 31998651 BACKGROUND

• 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.

  PMID: 33882446 BACKGROUND

• 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.

  PMID: 32659714 BACKGROUND

• 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.

  PMID: 27611236 BACKGROUND

• 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.

  PMID: 32130181 BACKGROUND

• 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.

  PMID: 31119709 BACKGROUND

• 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.

  PMID: 31008546 BACKGROUND

• 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.

  PMID: 22571072 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 4, 2022
• Study Start: April 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Study information will be shared in line with the appropriate requests of researchers via e-mail.
• Access Criteria: Study information will be shared in line with the appropriate requests of researchers via e-mail.

Locations

TU (1)