The Effect of Mobile Application-Assisted Nursing Services on Symptom Control in Breast Cancer Patients

NCT07200791 | Not Yet Recruiting DMC

• 1 other identifier: 82.2025fbu
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

Breast cancer is the most common type of cancer in women, accounting for approximately one-quarter of all female cancers in Turkey. Chemotherapy is widely used in treatment, but it also affects healthy cells, leading to numerous side effects such as fatigue, nausea, hair loss, sleep problems, and skin and nail changes. These side effects complicate symptom management and negatively impact patients' self-efficacy and quality of life. Mobile health applications allow patients to track their symptoms, communicate with healthcare professionals, and implement recommended non-pharmacological methods. Literature demonstrates that these applications reduce symptoms, improve quality of life, and enhance self-efficacy. This research is a randomized controlled experimental trial designed to evaluate the effect of mobile app-assisted nursing services on symptom management in women diagnosed with breast cancer and undergoing chemotherapy. The research will be conducted in the chemotherapy unit of a training and research hospital in Istanbul. The study will consist of two groups: an intervention group and a control group. Randomization will be conducted using a computer-assisted method (random.org). Based on the power analysis, 74 patients will be included in the sample for 85% power at a 95% confidence interval, a significance level of p\<0.05, and a medium effect size. Inclusion criteria include individuals aged 18 years and older, female, diagnosed with breast cancer, undergoing the 4AC-12 Paclitaxel protocol, owning and using a smartphone, and consenting to participate in the study. Exclusion criteria include patients with cardiac problems, liver or kidney failure, inability to use the mobile app, or providing incomplete data. Study data will be collected online via a mobile app. The results of the study will demonstrate the effectiveness of mobile health apps in symptom management, increasing self-efficacy, and improving quality of life.

Conditions

Symptom Management; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in Symptom Management Self-Efficacy

  Symptom severity will be assessed using the Edmonton Symptom Assessment Scale (ESAS). The ESAS is a validated tool developed to evaluate the severity of nine common symptoms experienced by patients undergoing cancer treatment, including pain, fatigue, nausea, depression, anxiety, drowsiness, appetite loss, well-being, and shortness of breath. Each symptom is rated on a numerical scale from 0 to 10, where 0 indicates no symptom and 10 indicates the worst possible severity. Higher scores represent more severe symptoms (worse outcome).

  Baseline and 12 weeks after intervention

Secondary Outcomes (1)

• Change in Quality of Life

  aseline and 12 weeks after intervention

Study Arms (2)

experimental arm(ıntervention group): Mobile application and usual care

EXPERIMENTAL

Participants in this group will receive routine nursing care and the standard hospital educational booklet. In addition, they will use a mobile application developed to support chemotherapy-related symptom management. The app includes modules for symptom tracking, short educational videos (approx. 2 minutes each), and written/visual brochures. Before use, participants will be trained on installation and navigation. They can also contact a nurse or researcher via the app for questions.

Behavioral: Mobile Application

Control Arm: Usual Care Only

ACTIVE COMPARATOR

Participants in this group will receive routine nursing care and the standard hospital educational booklet. No additional intervention will be provided.

Behavioral: Usual Care Only

Interventions

Mobile Application BEHAVIORAL

Participants in this group will receive routine nursing care and the standard hospital educational booklet. In addition, they will use a mobile application developed to support chemotherapy-related symptom management. The app includes modules for symptom tracking, short educational videos (approx. 2 minutes each), and written/visual brochures. Before use, participants will be trained on installation and navigation. They can also contact a nurse or researcher via the app for questions.

experimental arm(ıntervention group): Mobile application and usual care

Usual Care Only BEHAVIORAL

Participants in this group will receive routine nursing care and the standard hospital educational booklet. No additional intervention will be provided.

Control Arm: Usual Care Only

Eligibility Criteria

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

You may qualify if:

• yaş ve üzerinde olan,
• Çalışmaya katılmayı kabul eden,
• Meme kanseri tanısı alan kadınlar,
• AC-12 Paklitaksel tedavi protokolü uygulana,
• Okuma yazma bilen ve iletişim problemi olmayan,
• Akıllı telefonu olan bireyler
• Akıllı telefonu kullanabilen bireyler
• Verileri eksiksiz olarak dolduran bireyler

You may not qualify if:

• Kardiyak problemi olan bireyler
• Karaciğer ve böbrek yetmezliği olan bireyler
• Mobil uygulama kullanamayan bireyler
• Akıllı telefon kullanamayan bireyler
• Araştırmadan ayrılmak isteyen bireyler
• Araştırmada çeşitli sebeplerle eksik veri toplanan bireyler

Sponsors & Collaborators

• Fenerbahce University: lead

Central Study Contacts

Demet DEMET SEMİZ

CONTACT

05457120188; demet.semiz@fbu.edu.tr

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: Lecturer

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12