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

NCT ID: NCT05360407

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Using mobile information application about before and after surgery

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Using mobile information application about before and after surgery

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 Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

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Filiz Salman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suleyman Demirel University

Isparta, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32514909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32687476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30587936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32405966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31998651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33882446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32659714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27611236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32130181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31119709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31008546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22571072 (View on PubMed)

Other Identifiers

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SuleymanDU-SALMAN-F-001

Identifier Type: -

Identifier Source: org_study_id

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