The Effect of Mobile-Based Care and Monitoring on Lymphatic Edema Management and Quality of Life in Breast Surgery

NCT06203197 | Completed

• 1 other identifier: SankoU-Nursing-EK-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There is a lack of synthesized evidence focusing on the design and development of mobile applications targeting the care of patients with breast cancer. This gap will impede understanding of care through mobile applications and hinder digital health intervention strategies that support these patients. Considering the increasing needs of breast cancer patients, the magnitude of care burden, and the widespread use of mobile applications, increased studies are needed to improve care in this population. For this purpose, the mobile application to be developed in the project will include information that patients will need in the perioperative period, preoperative training, exercises to be done in the postoperative period, symptom management, nutrition and lifestyle content. Thus, it is thought that the mobile application will contribute to consultancy and care on issues such as patients' quality of life and symptom management.

Conditions

Breast Cancer

Keywords

breast cancer; post surgical nursing; life quality

Outcome Measures

Primary Outcomes (1)

• Functional Assessment Scale in Cancer Treatment (FACT-B):

  This scale was developed by the "Center on Outcomes, Research, and Education (CORE)" in the USA to determine the quality of life in cancer patients. The Functional Assessment Scale in Cancer Treatment (FACT) has been translated into 52 different languages and has scales for different types of cancer. Functional Assessment in Cancer Treatment-Breast Cancer (FACT-B) quality of life scale is a scale adapted to Turkish by the center that aims to measure the quality of life in breast cancer. Permission to use the scale was received by this center . All of the questions in the physical state sub-dimension and questions 1, 3, 4, 5 and 6 in the emotional state sub-dimension contain negative expressions. The total score of the scale varies between 0-144. The total score of the scale is evaluated in relation to the high quality of life.

  six month

Secondary Outcomes (3)

• Body Image and Sexual Adjustment Scale

  six month

• Lymph Edema Findings Evaluation Form

  six month

• Wound Site Evaluation Form

  two month

Study Arms (2)

control

NO INTERVENTION

Patients in the control group will receive routine clinical care after surgery.

intervention

EXPERIMENTAL

Patients in the intervention group will use the mobile-based care support application (M-Breast cancer personal care and monitoring system (M-MEKKBİS)) developed within the scope of the research after the surgery.

Other: Patients in the intervention group will use the mobile-based care support application (M-Breast cancer personal care and monitoring system (M-MEKKBİS)

Interventions

Patients in the intervention group will use the mobile-based care support application (M-Breast cancer personal care and monitoring system (M-MEKKBİS) OTHER

intervention group will use the mobile-based care support application (M-Breast cancer personal care and monitoring system (M-MEKKBİS).

intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: They will be included in the study because breast cancer is frequently seen in female gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over,
• Able to understand and speak Turkish,
• It is decided to undergo breast-conserving surgery or lymph node dissection,
• Using any of the social media applications (facebook, whatsapp, instagram)

You may not qualify if:

• Having another health problem (amputation, visible scar, visible physical disability, etc.) that may affect body image
• Those with speech, hearing and vision problems
• Having a psychiatric diagnosis
• Having a disease that restricts the movement of the upper extremity (rheumatological diseases, fracture, health problem that will cause joint restriction, amputation, etc.).
• Never used the application
• Study termination criteria;
• Discontinuation of communication with the patient before the data collection stages are completed
• Leaving work voluntarily

Sponsors & Collaborators

• Sanko University: lead
• University of Gaziantep: collaborator

Study Sites (1)

Ebru Karaaslan

Şehitkamil, Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• ebru karaaslan

  University of Gaziantep

  STUDY DIRECTOR

Study Design

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

Model Details: two groups with conventional care control groups

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: March 15, 2024
• Primary Completion: October 30, 2024
• Study Completion: August 30, 2025
• Last Updated: January 29, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)