Symptom ManagementNCT06505538
Nurse-Led Mobile App Effect on Symptom Management for Breast Cancer Patients After Surgery
A study testing NL-Mapp in people with Symptom Management and Breast Care Nurse, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial summary
Background: The use of the Nurse-Led Mobile App (NL-Mapp) is a current and important option for educating patients about the symptoms that may arise from breast cancer surgery. Introduction: Given the precise information and counseling services offered to breast cancer patients, NL-Mapp is considered an appropriate… Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Symptom Management, Breast Care Nurse, Mobile App
- What is being tested?
- NL-Mapp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speaking the national language,
- The presence of primary breast cancer,
- The utilization of a smartphone for a minimum of one year,
- An age of 20 years
Who cannot join
- An uncontrollable medical problem,
- Having speech problems,
- Having hearing problems,
- Vision impairment,
- A psychiatric diagnosis/ongoing treatment
- Previous treatment due to a different type of cancer
Show all 10Show fewer
- Rheumatological diseases,
- Fractures,
- Health problems leading to joint limitation,
- Amputation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-Led Mobile App Effect on Symptom Management for Breast Cancer Patients After Surgery: A Quasi-Experimental Study
Background: The use of the Nurse-Led Mobile App (NL-Mapp) is a current and important option for educating patients about the symptoms that may arise from breast cancer surgery.
Introduction: Given the precise information and counseling services offered to breast cancer patients, NL-Mapp is considered an appropriate choice to support postoperative self-care.
Methods: This quasi-experimental study aimed to determine the impact of NL-Mapp on breast cancer patients after surgery. The study included 45 patients in the intervention group and 45 patients in the control group. First, NL-Mapp was developed by the research team. Patients were then taught how to use the app to manage their symptoms after breast cancer surgery, and online counseling was provided for patients' questions. The intervention started before surgery, and follow-up visits were made before discharge and in the first month.
- Conditions
- Symptom Management, Breast Care Nurse, Mobile App, Mobile Health
- Being tested
- NL-Mapp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NL-MappDevice
Mobile applicaiton
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: NL-Mapp |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function of the affected arm
ASES Shoulder Rating Scale
Measured: three months
Body image and sexual adjustment scale
Sexual Adjustment and Body Image Scale
Measured: three months
Pain scale
Visual Analog Scale
Measured: three months
Secondary outcomes (1)
Quality of life scale
Functional Assessment of Cancer Therapy-Breast
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptom ManagementStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Collaborators
- Semahat Arsel Nursing Education, Practice and Research Center (SANERC)
- Responsible party
- Principal investigator, Aydanur Aydin, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505538
- Sponsor's protocol ID
- GumushaneUni1
- Status last verified
- Jul 2024
- First submitted
- 1 Mar 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aydin A, Gursoy A. Nurse-Led Mobile App Effect on Quality of Life in Breast Cancer Patients After Surgery: Nonrandomized Controlled Prospective Cohort Study (Step 3). Cancer Nurs. 2026 May-Jun 01;49(3):E275-E281. doi: 10.1097/NCC.0000000000001418. Epub 2024 Nov 20.
PubMed 39565096
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Mobile App Effect on Symptom Management for Breast Cancer Patients After Surgery: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT06505538
- Acronym / sponsor ID
- GumushaneUni1
- Conditions
- Symptom Management, Breast Care Nurse, Mobile App, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Collaborators
- Semahat Arsel Nursing Education, Practice and Research Center (SANERC)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 17 Jul 2024 (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.
Background: The use of the Nurse-Led Mobile App (NL-Mapp) is a current and important option for educating patients about the symptoms that may arise from breast cancer surgery.
Introduction: Given the precise information and counseling services offered to breast cancer patients, NL-Mapp is considered an appropriate choice to support postoperative self-care.
Methods: This quasi-experimental study aimed to determine the impact of NL-Mapp on breast cancer patients after surgery. The study included 45 patients in the intervention group and 45 patients in the control group. First, NL-Mapp was developed by the research team. Patients were then taught how to use the app to manage their symptoms after breast cancer surgery, and online counseling was provided for patients' questions. The intervention started before surgery, and follow-up visits were made before discharge and in the first month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: NL-Mapp |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Speaking the national language,
- The presence of primary breast cancer,
- The utilization of a smartphone for a minimum of one year,
- An age of 20 years
Key exclusion criteria (10 listed)
- An uncontrollable medical problem,
- Having speech problems,
- Having hearing problems,
- Vision impairment,
- A psychiatric diagnosis/ongoing treatment
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 |
|---|---|---|
| NL-MappMobile applicaiton | Device | Intervention |
Primary outcome
Function of the affected arm
Time frame: three months
ASES Shoulder Rating Scale
Body image and sexual adjustment scale
Time frame: three months
Sexual Adjustment and Body Image Scale
Pain scale
Time frame: three months
Visual Analog Scale
1 secondary outcome
Quality of life scale
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Derived from this study: PubMed 39565096Aydin A, Gursoy A. Nurse-Led Mobile App Effect on Quality of Life in Breast Cancer Patients After Surgery: Nonrandomized Controlled Prospective Cohort Study (Step 3). Cancer Nurs. 2026 May-Jun 01;49(3):E275-E281. doi: 10.1097/NCC.0000000000001418. Epub 2024 Nov 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NL-Mapp in people with Symptom Management and Breast Care Nurse, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function of the affected arm (time frame: three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505538, which also lists 1 linked publication.
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 17 Jul 2024.