The Effect of Mobile Application-Assisted Nursing Services on Symptom Control in Breast Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFenerbahce University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 yaş ve üzerinde olan,
Çalışmaya katılmayı kabul eden,
Meme kanseri tanısı alan kadınlar,
4AC-12 Paklitaksel tedavi protokolü uygulana,
Disqualifiers
Kardiyak problemi olan bireyler
Karaciğer ve böbrek yetmezliği olan bireyler
Mobil uygulama kullanamayan bireyler
Akıllı telefon kullanamayan bireyler
Trial design
Design model
Parallel
Treatments tested in this trial
Mobile Application
BehavioralParticipants 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.
Usual Care Only
BehavioralParticipants in this group will receive routine nursing care and the standard hospital educational booklet. No additional intervention will be provided.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: experimental arm(ıntervention group): Mobile application and usual careExperimental treatment 1 intervention
Group B: Control Arm: Usual Care OnlyActive comparator 1 intervention
Trial outcomes
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).
Time frame
Baseline and 12 weeks after interventionSecondary outcomes
1
Change in Quality of Life
Self-efficacy will be measured using the Cancer Behavior Inventory - Brief Version (CBI-B), a validated instrument designed to assess self-efficacy for coping with cancer. The scale consists of 12 items, each rated on a 9-point Likert scale ranging from 1 (not at all confident) to 9 (totally confident). Scores are averaged to obtain a total self-efficacy score. Higher scores indicate greater self-efficacy (better outcome), reflecting the participant's stronger confidence in managing symptoms, treatment side effects, and emotional challenges related to cancer.
Time frame
aseline and 12 weeks after interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: