The Effect of the Mobile Application-based Support Program on the Outcomes of Breast Cancer Patients in the Pandemic

NCT05739175 | Completed

• 1 other identifier: Zz123456.
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer remains the most common type of cancer in the world. Cancer itself and chemotherapy treatment, which is one of the most important treatment steps, may cause unwanted physical, social and psychological effects (symptoms) for the patient. These effects significantly affect the patient's quality of life. It is possible to manage the symptoms and reduce their destructive effects with professional care and treatment support that includes evidence-based practices. On the other hand, breast cancer patients receiving chemotherapy during the Coronavirus Pandemic form the risk group in terms of infection; On the one hand, the continued treatment and care support, on the other hand, required changes in the approach to the patient in order to reduce the risk of infection. In addition to reducing the risk of infection, mobile applications can create an alternative during the coronavirus Pandemic. process in order to maintain quality and uninterrupted care and treatment. This study is planned to be conducted analytically in a randomized controlled single-blind pattern in order to determine the effect of the interactive nurse support program developed with the mobile application on the patient outcomes (symptom management, quality of life, social support perception and anxiety) in breast cancer patients who received chemotherapy during the coronavirus pandemic. Within the scope of the study, interactive nurse support developed with mobile application will be applied to the research group from patients who apply to the polyclinic to receive chemotherapy treatment, and the control group will receive standard care. As a result of the analysis of the data collected systematically with forms and scales, the effect of the interactive nurse support program developed with the mobile application on patient outcomes (symptom management, quality of life, social support perception and anxiety) will be evaluated and recommendations will be made regarding the use of the application in patients with breast cancer.

Conditions

Breast Cancer; Nursing

Keywords

Breast cancer; Nursing; Mobile Application; Pandemic; Symptom management

Outcome Measures

Primary Outcomes (4)

• Change of EORTC QLQ-C30 Quality of Life Scale and QLQ-BR23 Module score at baseline and one week later after first, second, third and fourth chemotherapy.

  EORTC QLQ-C30 Quality of Life Scale was developed by Aronson in 1993.Turkish validity and reliability of the scale made by Beşer and Öz in 2003.The scale consists of three subgroups as general well-being, functional area and symptoms and includes 30 questions for the past week. The first 28 of the 30 items in the scale are a four-point Likert scale. In the 29th question of the scale, the patient is asked to evaluate his health on a scale of 1 to 7 (1: very poor and 7: excellent), and in the 30th question, the general quality of life.High functional area and general well-being subgroup scores and low symptom subgroup scores indicate a high quality of life. EORTC QLQ-BR23 Breast Cancer Module was developed by Srangers at al. in 1996.It consists of 23 items.High functional dimension scores indicate high quality of life. A high score on the symptoms dimension indicates a low quality of life.

  The first measurement will be made before chemotherapy. The second, third, fourth, and fifth measurement will be made one week after the first, second, third, and fourth chemotherapy, respectively.

• Change of Memorial Symptom Assesment Scale score at baseline and one week later after first, second, third and fourth chemotherapy.

  Memorial Symptom Assesment Scale was developed by Portenoy et al. in 1994. Turkish validity and reliability of the scale made by Yıldırım et al. in 2011. The scale is used to evaluate the frequency and severity of symptoms experienced by cancer patients during the past seven days. It consists of 32 symptoms. While the 'frequency' and 'intensity' levels of the symptoms are answered as a 4-point likert, the 'distress' levels are answered as a 5-point likert. Total score is obtained by averaging thirty-two symptom scores. Each symptom score is calculated by averaging the frequency, severity, and degree of distress.

  The first measurement will be made before chemotherapy. The second, third, fourth, and fifth measurement will be made one week after the first, second, third, and fourth chemotherapy, respectively.

• Change of Multidimensional Scale of Perceived Social Support score at baseline and one week later after first, second, third and fourth chemotherapy.

  Multidimensional Scale of Perceived Social Support was developed by Zimet et al. in 1988. Turkish validity and reliability of MSPSS was performed by Eker et al. MSPSS consists of 12 items and 3 sub-dimensions that subjectively evaluate the adequacy of social support from three different sources. These sub-dimensions are family, friends, and a special person. Each item was rated using a 7-point scale. The person to whom the scale was applied can give at least 1 point to the sentence that he disagreed with, and maximum 7 points to the sentence that he agrees with. As the score given to each item increases, the perceived social support also increases. Any score between 12 and 84 (min.-max.) can be obtained from the scale. The Cronbach Alpha coefficient of the scale is 0.89

  The first measurement will be made before chemotherapy. The second, third, fourth, and fifth measurement will be made one week after the first, second, third, and fourth chemotherapy, respectively.

• Change of Beck Anxiety Inventory scale score at baseline and one week later after first, second, third and fourth chemotherapy.

  Beck Anxiety Scale was developed by Aeron T. Beck in 1988 to measure anxiety in cancer It was translated into Turkish by Ulusoy et al in 1998 and validated. İtems in the scale describe the subjective, somatic and panic symptoms of anxiety. The scores obtained from all items are summed as "0=none, 1=mild, 2=moderate, 3=severe" for each item. The score range is between 0-63 (min.-max.) 8-15 points indicates mild anxiety, 16-25 points indicates moderate anxiety, 26-63 points indicates severe anxiety. A high total scale score indicates high anxiety. The Cronbach Alpha coefficient of the scale is 0.93.

  The first measurement will be made before chemotherapy. The second, third, fourth, and fifth measurement will be made one week after the first, second, third, and fourth chemotherapy, respectively.

Study Arms (2)

Intervention group receiving interactive nurse support based on mobile application

EXPERIMENTAL

Experimental: Intervention Group The mobile application containing an interactive nurse support program will be uploaded to the telephone of the intervention group patients. Patients will be informed on how to use the mobile application. Data will be collected face-to-face before chemotherapy begins and by telephone one week after every four chemotherapy. Demographic/Clinical Information Form, Eastern Cooperative Oncology Group Performance Scale, Multidimensional scale of perceived social support, Memorial Symptom Rating Scale, European Organization for Research and Treatment of Cancer- Quality of Life, QLQ-BR23, Beck Anxiety Scale and Mobile Application evaluation form will be used to collect data.

Device: Mobile Application with Interactive Nurse Support

Control group receiving standard care and no intervention

NO INTERVENTION

No Intervention: Control Group The patients received routine care and training in the polyclinic, and no additional intervention was applied. Data will be collected face-to-face before chemotherapy begins and by telephone one week after every four chemotherapy.Demographic/Clinical Information Form, Eastern Cooperative Oncology Group Performance Scale, Multidimensional scale of perceived social support, Memorial Symptom Rating Scale, European Organization for Research and Treatment of Cancer- Quality of Life, QLQ-BR23,Beck Anxiety will be used to collect data.

Interventions

Mobile Application with Interactive Nurse Support DEVICE

A mobile application containing an interactive nurse support program will be applied to the patients in the experimental group and its effect on patient outcomes will be evaluated through scales. The mobile application consists of three modules. The first part is a learning module with videos on Covid 19, breast cancer and chemotherapy related side effects management. Second part is ask the nurse/doctor. Third part is patient experiences module. After the participants download the mobile application to their phones, they can log in to the application with a valid e-mail address and password.

Intervention group receiving interactive nurse support based on mobile application

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years or older,
• Volunteering to participate in the research,
• Having been diagnosed with breast cancer (Stage 0,1,2),
• Being able to understand and speak Turkish,
• ECOG performance scale score of 0, 1 and 2
• Being literate
• Owning a mobile phone with Android or iphone operating system processor and using the phone effectively
• Receiving chemotherapy treatment for the first time

You may not qualify if:

• Refusal to participate in the research,
• Diagnosing metastatic breast cancer (Stage 3,4),
• Receiving simultaneous radiotherapy or biotherapy with chemotherapy,
• Having visual, auditory or mental problems,
• Having a psychiatric diagnosis,
• Those who have received chemotherapy before
• ECOG performance scale score of 3 and 4,
• Taking part in another research that will affect the research results

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• Ozdemir H, Demir A, Bardakci M, Uncu D. The effect of an interactive nurse support program developed with a mobile application on patient outcomes in breast cancer patients who received outpatient chemotherapy: A randomized controlled trial. Eur J Oncol Nurs. 2025 Jun;76:102882. doi: 10.1016/j.ejon.2025.102882. Epub 2025 Mar 25.

  PMID: 40185060 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Doğan Uncu, professor

  Ankara Bilkent Central Hospital

  STUDY DIRECTOR

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: Phd Candidate

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: February 22, 2023
• Study Start: July 15, 2022
• Primary Completion: January 30, 2024
• Study Completion: February 15, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

TU (1)