Effect of Mobile Application-Supported Nursing Service on Symptom Management in Breast Cancer Patients During Chemotherapy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 74
- Primary Endpoint
- Change in Symptom Management Self-Efficacy
Study Overview
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.
Detailed Description
Breast cancer is the most prevalent malignancy among women in Türkiye, representing approximately one-fourth of all female cancers. Chemotherapy remains a cornerstone of treatment but often causes multiple physical and psychological side effects. Common symptoms such as fatigue, nausea, alopecia, sleep disturbances, skin and nail changes, and emotional stress complicate self-management and reduce quality of life.
Mobile health (mHealth) applications offer an innovative approach for patients to self-monitor symptoms, access educational materials, and communicate with healthcare professionals in real time. Recent evidence indicates that mHealth-based nursing interventions can improve symptom control, enhance self-efficacy, and support adherence to non-pharmacological management strategies during chemotherapy.
This randomized controlled experimental study aims to evaluate the effectiveness of a mobile application-assisted nursing intervention on symptom management, self-efficacy, and quality of life among women diagnosed with breast cancer and receiving chemotherapy. The study will be conducted in the chemotherapy unit of a training and research hospital in Istanbul, Türkiye.
A total of 74 participants will be randomly assigned to either the intervention or control group using a computer-generated randomization system (random.org). The intervention group will receive routine nursing care plus access to a specifically designed mobile application developed for this study.
The mobile application includes:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 yaş ve üzerinde olan,
- •Çalışmaya katılmayı kabul eden,
- •Meme kanseri tanısı alan kadınlar,
- •4AC-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
Exclusion Criteria
- •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
Arms & Interventions
experimental arm(ıntervention group): Mobile application and usual care
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.
Intervention: Mobile Application (Behavioral)
Control Arm: Usual Care Only
Participants in this group will receive routine nursing care and the standard hospital educational booklet. No additional intervention will be provided.
Intervention: Usual Care Only (Behavioral)
Outcomes
Primary Outcomes
Change in Symptom Management Self-Efficacy
Time Frame: Baseline and 12 weeks after intervention
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).
Change in Symptom Management Self-Efficacy
Time Frame: Baseline and 12 weeks after intervention
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).
Secondary Outcomes
- Change in Quality of Life(aseline and 12 weeks after intervention)
- Change in Quality of Life(aseline and 12 weeks after intervention)
Investigators
Demet SEMİZ
Lecturer
Fenerbahce University