Non Small Cell Lung Cancer[LungCaNN]NCT05937425
The Effect of Nurse Navigation Program on Lung Cancer Patients
A study testing LungCaNN in people with Non Small Cell Lung Cancer, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to determine the effect of the nurse navigation program (LungCaNN), which is performed in line with the supportive care needs of newly diagnosed non-small cell lung cancer patients, on the level of anxiety-depression, adherence to the disease, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- LungCaNN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2023to 6 Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Know how to read and write No hearing or speech problems Be able to use the phone The primary medical diagnosis is non-small cell lung cancer Karnofsky Performance Scale score of 70% or higher Patients with a stress thermometer of 4 and above At most six weeks past the date of diagnosis
Who cannot join
- Patients with cognitive problems Expected life expectancy is less than three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nurse Navigation Program Applied in Line With Supportive Care Needs in Patients Diagnosed With Lung Cancer on Anxiety-Depression, Adaptation to the Disease and Quality of Life
The study aims to determine the effect of the nurse navigation program (LungCaNN), which is performed in line with the supportive care needs of newly diagnosed non-small cell lung cancer patients, on the level of anxiety-depression, adherence to the disease, and quality of life.
The study was designed as a randomized study with a control group. This study will be carried out with a total of 84 NSCLC patients, 42 of whom were in the intervention group and 42 in the control group, whose treatment was started in Akdeniz University Medical Oncology Outpatient Clinic and met the inclusion criteria of the sampling. Nurse navigation program will be applied for 12 weeks from the diagnosis of NSCLC patients in the intervention group. The intervention protocol of the study is abbreviated as "Lung Cancer Nurse Navigator" [LungCaNN].
Within the scope of the LungCaNN program, face-to-face patient education, patient education booklet, face-to-face, and telephone navigation initiatives were planned. Patient Identification Form, Depression Anxiety Stress Scale (DASS 21), Chronic Disease Adjustment Scale, EORTC QLQ 30 Quality of Life Scale-/ LC-13, and Navigation and Interview Steps Form will be used to collect data.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- LungCaNN
- Keywords
- Cancer, Nurse Navigator, Nurse Navigation Program, Individualized Care, Anxiety-Depression, Adaptation to the Disease, Quality of Life
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LungCaNNOther
The needs of the patients included in the study will be determined with the supportive care needs scale. A training booklet will be given to the patients in the intervention group and they will be informed about the existing or newly formed unsupported care needs, the evaluation of their frequency and severity, and the ability of the patients to call the navigator nurse 24/7 or send an SMS. For interventions that can be applied in line with evidence-based guidelines for unsupported care needs with patients included in the intervention group every week for 12 weeks, a face-to-face navigation will be made by the navigator nurse over the phone and once a month.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Effects of nurse navigation program on patients with lung cancer Receives: Other: LungCaNN |
| Control group | No intervention | An information note will be given to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Stress, Anxiety Scale (DASS21)
It is used to evaluate depression, stress, and anxiety levels. Each item scores between 0-3 and gives separate scores for depression, stress, and anxiety. A maximum of 21 and a minimum of 0 points can be obtained from the scales. High scores indicate high levels of depression, stress, and anxiety.
Measured: change from baseline DASS21 at 12 week
EORTC QLQ - C30 Quality of Life Scale/ LC-13 Lung Module
This scale was developed to measure the quality of life of cancer patients. It includes 30 questions and three sub-dimensions: General Well-being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100 and the minimum score is 0. High scores in the functional subscale indicate good/healthy functional status, high scores in the symptom subscale indicate high levels of symptoms and/or problems, and high scores in the global health status/quality of life subscale indicate good quality of life. Scoring of the Quality of Life Scale LC-13 Lung Module is also done by symptom scale scoring. A high score from the LC-13 Lung Module indicates that the symptoms are experienced intensely.
Measured: change from baseline EORTC QLQ - C30 Quality of Life Scale/ LC-13 Lung Module at 12 week
Scale of Adjustment to Chronic Diseases
The scale was developed to determine the level of compliance of patients with the disease. It consists of 25 items. It consists of three sub-dimensions: Physical Adaptation, Social Adaptation, and Psychological Adaptation. The total score that can be obtained from the scale is 125. High scores from the sub-dimensions and/or the whole scale mean that the patient's level of compliance with the disease also increases.
Measured: change from baseline Scale of Adjustment to Chronic Diseases at 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start5 Jun 2023
- Primary completion15 Jul 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Model description
- This is a randomized controlled trial consisting of two groups: experimental and control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Müge ALTINIŞIK, Akdeniz University
- Investigators
- Fatma Arikan, PhD, RN, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937425
- Sponsor's protocol ID
- 240778
- Acronym
- [LungCaNN]
- Status last verified
- Jan 2025
- First submitted
- 22 Jun 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse Navigation Program Applied in Line With Supportive Care Needs in Patients Diagnosed With Lung Cancer on Anxiety-Depression, Adaptation to the Disease and Quality of Life
- ClinicalTrials.gov ID
- NCT05937425
- Acronym / sponsor ID
- [LungCaNN] / 240778
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Cancer, Nurse Navigator, Nurse Navigation Program, Individualized Care, Anxiety-Depression, Adaptation to the Disease, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 10 Jul 2023 (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.
The study aims to determine the effect of the nurse navigation program (LungCaNN), which is performed in line with the supportive care needs of newly diagnosed non-small cell lung cancer patients, on the level of anxiety-depression, adherence to the disease, and quality of life.
The study was designed as a randomized study with a control group. This study will be carried out with a total of 84 NSCLC patients, 42 of whom were in the intervention group and 42 in the control group, whose treatment was started in Akdeniz University Medical Oncology Outpatient Clinic and met the inclusion criteria of the sampling. Nurse navigation program will be applied for 12 weeks from the diagnosis of NSCLC patients in the intervention group. The intervention protocol of the study is abbreviated as "Lung Cancer Nurse Navigator" [LungCaNN].
Within the scope of the LungCaNN program, face-to-face patient education, patient education booklet, face-to-face, and telephone navigation initiatives were planned. Patient Identification Form, Depression Anxiety Stress Scale (DASS 21), Chronic Disease Adjustment Scale, EORTC QLQ 30 Quality of Life Scale-/ LC-13, and Navigation and Interview Steps Form will be used to collect data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial consisting of two groups: experimental and control.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: LungCaNNEffects of nurse navigation program on patients with lung cancer |
| Control group | No intervention | –An information note will be given to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Know how to read and write No hearing or speech problems Be able to use the phone The primary medical diagnosis is non-small cell lung cancer Karnofsky Performance Scale score of 70% or higher Patients with a stress thermometer of 4 and above At most six weeks past the date of diagnosis
Key exclusion criteria (1 listed)
- Patients with cognitive problems Expected life expectancy is less than three months
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 |
|---|---|---|
| LungCaNNThe needs of the patients included in the study will be determined with the supportive care needs scale. A training booklet will be given to the patients in the intervention group and they will be informed about the existing or newly formed unsupported care needs, the evaluation of their frequency and severity, and the ability of the patients to call the navigator nurse 24/7 or send an SMS. For interventions that can be applied in line with evidence-based guidelines for unsupported care needs with patients included in the intervention group every week for 12 weeks, a face-to-face navigation will be made by the navigator nurse over the phone and once a month. | Other | Intervention group |
Primary outcome
Depression, Stress, Anxiety Scale (DASS21)
Time frame: change from baseline DASS21 at 12 week
It is used to evaluate depression, stress, and anxiety levels. Each item scores between 0-3 and gives separate scores for depression, stress, and anxiety. A maximum of 21 and a minimum of 0 points can be obtained from the scales. High scores indicate high levels of depression, stress, and anxiety.
EORTC QLQ - C30 Quality of Life Scale/ LC-13 Lung Module
Time frame: change from baseline EORTC QLQ - C30 Quality of Life Scale/ LC-13 Lung Module at 12 week
This scale was developed to measure the quality of life of cancer patients. It includes 30 questions and three sub-dimensions: General Well-being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100 and the minimum score is 0. High scores in the functional subscale indicate good/healthy functional status, high scores in the symptom subscale indicate high levels of symptoms and/or problems, and high scores in the global health status/quality of life subscale indicate good quality of life. Scoring of the Quality of Life Scale LC-13 Lung Module is also done by symptom scale scoring. A high score from the LC-13 Lung Module indicates that the symptoms are experienced intensely.
Scale of Adjustment to Chronic Diseases
Time frame: change from baseline Scale of Adjustment to Chronic Diseases at 12 week
The scale was developed to determine the level of compliance of patients with the disease. It consists of 25 items. It consists of three sub-dimensions: Physical Adaptation, Social Adaptation, and Psychological Adaptation. The total score that can be obtained from the scale is 125. High scores from the sub-dimensions and/or the whole scale mean that the patient's level of compliance with the disease also increases.
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 29 Jan 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. This study is not recruiting at the moment.
Fatma Arikan, PhD, RN study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LungCaNN in people with Non Small Cell Lung Cancer, run by Akdeniz University 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 1 inclusion and 1 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 29 Jan 2025. 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?
Depression, Stress, Anxiety Scale (DASS21) (time frame: change from baseline DASS21 at 12 week). 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?
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 29 Jan 2025.