Symptom ManagementNCT07200791
The Effect of Mobile Application-Assisted Nursing Services on Symptom Control in Breast Cancer Patients
A study testing Mobile Application in people with Symptom Management and Quality of Life, run by Fenerbahce University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Symptom Management, Quality of Life
- What is being tested?
- Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Mobile Application-Supported Nursing Service on Symptom Management in Breast Cancer Patients During Chemotherapy: A Randomized Controlled 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.
Read more
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.
Read the 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:
A symptom monitoring module for daily recording of symptom severity using the Edmonton Symptom Assessment Scale (VAS 0-10).
Educational and behavioral guidance on fatigue management, nutrition, sleep hygiene, and coping with nausea.
Interactive features providing daily reminders, self-care tips, and remote nursing follow-up capabilities.
Participants in the intervention group will actively use the mobile application throughout their chemotherapy protocol (4AC-12 Paclitaxel regimen, approximately 16 weeks). The control group will receive standard nursing care only.
Inclusion Criteria
Women aged 18 years or older
Diagnosed with breast cancer
Undergoing the 4AC-12 Paclitaxel chemotherapy protocol
Literate and able to communicate effectively
Owning a smartphone
Able to use a smartphone and mobile application
Voluntarily consenting to participate in the study
Completing all required data collection forms
Exclusion Criteria
Individuals with cardiac disease
Individuals with liver or renal failure
Individuals unable to use a smartphone or the mobile application
Individuals who withdraw from the study at any stage
Participants with incomplete or missing data for any reason
Outcome Measures
Primary Outcome:
Change in symptom severity measured by the Edmonton Symptom Assessment Scale (VAS 0-10) at baseline, mid-intervention, and post-intervention.
Secondary Outcomes:
Change in self-efficacy level, measured using the Self-Efficacy Scale.
Change in quality of life, measured by the EORTC QLQ-C30 or Quality of Life Scale at three time points (T0, T1, T2).
Study data will be collected electronically through the mobile application and analyzed using appropriate statistical methods (descriptive statistics, paired and independent t-tests, and regression analysis).
This study is expected to provide scientific evidence for the use of mobile health technologies as supportive nursing tools in oncology care, demonstrating their potential to enhance symptom management, strengthen self-efficacy, and improve patients' quality of life during chemotherapy.
- Conditions
- Symptom Management, Quality of Life
- Being tested
- Mobile Application, Usual Care Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationBehavioural
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.
Usual Care OnlyBehavioural
Participants in this group will receive routine nursing care and the standard hospital educational booklet. No additional intervention will be provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 12 weeks after intervention
Secondary 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.
Measured: aseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startDec 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom ManagementStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet SEMİZ, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200791
- Sponsor's protocol ID
- 82.2025fbu
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Application-Supported Nursing Service on Symptom Management in Breast Cancer Patients During Chemotherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07200791
- Acronym / sponsor ID
- 82.2025fbu
- Conditions
- Symptom Management, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
A symptom monitoring module for daily recording of symptom severity using the Edmonton Symptom Assessment Scale (VAS 0-10).
Educational and behavioral guidance on fatigue management, nutrition, sleep hygiene, and coping with nausea.
Interactive features providing daily reminders, self-care tips, and remote nursing follow-up capabilities.
Participants in the intervention group will actively use the mobile application throughout their chemotherapy protocol (4AC-12 Paclitaxel regimen, approximately 16 weeks). The control group will receive standard nursing care only.
Inclusion Criteria
Women aged 18 years or older
Diagnosed with breast cancer
Undergoing the 4AC-12 Paclitaxel chemotherapy protocol
Literate and able to communicate effectively
Owning a smartphone
Able to use a smartphone and mobile application
Voluntarily consenting to participate in the study
Completing all required data collection forms
Exclusion Criteria
Individuals with cardiac disease
Individuals with liver or renal failure
Individuals unable to use a smartphone or the mobile application
Individuals who withdraw from the study at any stage
Participants with incomplete or missing data for any reason
Outcome Measures
Primary Outcome:
Change in symptom severity measured by the Edmonton Symptom Assessment Scale (VAS 0-10) at baseline, mid-intervention, and post-intervention.
Secondary Outcomes:
Change in self-efficacy level, measured using the Self-Efficacy Scale.
Change in quality of life, measured by the EORTC QLQ-C30 or Quality of Life Scale at three time points (T0, T1, T2).
Study data will be collected electronically through the mobile application and analyzed using appropriate statistical methods (descriptive statistics, paired and independent t-tests, and regression analysis).
This study is expected to provide scientific evidence for the use of mobile health technologies as supportive nursing tools in oncology care, demonstrating their potential to enhance symptom management, strengthen self-efficacy, and improve patients' quality of life during chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm(ıntervention group): Mobile application and usual care | Experimental | Behavioral: Mobile ApplicationParticipants 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. |
| Control Arm: Usual Care Only | Active comparator | Behavioral: Usual Care OnlyParticipants in this group will receive routine nursing care and the standard hospital educational booklet. No additional intervention will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- Kardiyak problemi olan bireyler
- Karaciğer ve böbrek yetmezliği olan bireyler
- Mobil uygulama kullanamayan bireyler
- Akıllı telefon kullanamayan bireyler
- Araştırmadan ayrılmak isteyen bireyler
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile ApplicationParticipants 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. | Behavioural | experimental arm(ıntervention group): Mobile application and usual care |
| Usual Care OnlyParticipants in this group will receive routine nursing care and the standard hospital educational booklet. No additional intervention will be provided. | Behavioural | Control Arm: Usual Care Only |
Primary 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).
1 secondary outcome
Change in Quality of Life
Time frame: aseline and 12 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application in people with Symptom Management and Quality of Life, run by Fenerbahce University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demet DEMET SEMİZ (05457120188, demet.semiz@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Management Self-Efficacy (time frame: Baseline and 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.