Nurse-led Supportive CareNCT06204289
Effects of Nurse-led Supportive Care Programme on Caregiver Burden and Resilience of Family Caregivers
A study testing Nurse-led Supportive Care Programme in people with Nurse-led Supportive Care, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Lung cancer is the leading cause of cancer-related deaths worldwide, with a mortality rate of 18%. The prognosis of lung cancer is progressive and devastating, which may cause patients to experience problems during the treatment and care process. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse-led Supportive Care
- What is being tested?
- Nurse-led Supportive Care Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2023to 29 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A family member who has been a primary caregiver for at least one year
- Literate
- Willingness to participate in the study
Who cannot join
- Have any communication disability
- Have any diagnosed physical or psychological disorder
- Receiving any supportive care
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bakircay University Faculty of Health Sciences
Izmir, 35560
About this study
Official title: Effects of Nurse-led Supportive Care Programme on Caregiver Burden and Resilience of Family Caregivers of Patients With Lung Cancer: A Pragmatic Randomized Controlled Trial
Lung cancer is the leading cause of cancer-related deaths worldwide, with a mortality rate of 18%. The prognosis of lung cancer is progressive and devastating, which may cause patients to experience problems during the treatment and care process. Due to the problems experienced by lung cancer patients, their need for support increases and the care process is provided mostly in the home environment, causing family members to take on important roles as caregivers. Therefore, the resilience of family caregivers decreases and they feel burden.
- Conditions
- Nurse-led Supportive Care
- Being tested
- Nurse-led Supportive Care Programme
- Keywords
- Lung cancer, Family caregivers, Caregiver burden, Resilience
- Medical subject headings
- Lung Neoplasms, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Supportive Care ProgrammeBehavioural
Nurse-led supportive care programme was applied to family caregivers for eight weeks in the form of face-to-face clinic interviews. It took an average of 40 minutes to interview with family caregivers at the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led Supportive Care Group | Experimental | Nurse-led supportive care was given to family caregivers of patients with lung cancer. Receives: Behavioral: Nurse-led Supportive Care Programme |
| Control Group | No intervention | The control group received only usual care. They did not receive any intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Burden Interview (ZBI)
The ZBI is a measure of caregiving burden developed by Zarit et al. (1980). The Turkish version of this scale has been validated by Inci and Erdem (2018). It consists of 22 items, and responses are recorded on a five-point Likert scale. The level of caregiver burden can be ascertained based on the total scale scores, which range from 0 to 88. Higher scores indicate a higher level of caregiver burden.The Cronbach's α of the Turkish version of this scale was 0.91 in Inci and Erdem (2018) validation study.
Measured: The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.
Secondary outcomes (1)
Connor-Davidson Resilience Scale Short Form (CDRSSF)
The CDRSSF was developed to determine the psychological resilience of individuals, which enables them to return to their former state after negative events they have experienced.It is a 5-point Likert-type scale with 10 items.The level of resilience can be ascertained based on the total scale scores, which range from 0 to 40. High scores obtained from the scale are considered as high psychological resilience. The Turkish validity and reliability of the scale was conducted by Kaya and Odacı (2020).
Measured: The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start31 Jul 2023
- Primary completion22 Jan 2024
- Study completion29 Feb 2024
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 Nurse-led Supportive CareStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Zorba Bahceli, PhD RN, Izmir Bakircay University
- Investigators
- Pinar Zorba Bahceli, PhD, Study director, Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204289
- Sponsor's protocol ID
- 2022/754
- Status last verified
- Aug 2024
- First submitted
- 3 Jan 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karaca M, Zorba Bahceli P. The Effects of a Nurse-Led Supportive Care Program on Caregiver Burden and Family Resilience of Caregivers of Patients with Lung Cancer: A Pragmatic Randomized Controlled Trial. Semin Oncol Nurs. 2026 Aug;42(4):152171. doi: 10.1016/j.soncn.2026.152171. Epub 2026 Feb 28.
PubMed 41765744
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nurse-led Supportive Care Programme on Caregiver Burden and Resilience of Family Caregivers of Patients With Lung Cancer: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06204289
- Acronym / sponsor ID
- 2022/754
- Conditions
- Nurse-led Supportive Care
- Keywords
- Lung cancer, Family caregivers, Caregiver burden, Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 12 Jan 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.
Lung cancer is the leading cause of cancer-related deaths worldwide, with a mortality rate of 18%. The prognosis of lung cancer is progressive and devastating, which may cause patients to experience problems during the treatment and care process. Due to the problems experienced by lung cancer patients, their need for support increases and the care process is provided mostly in the home environment, causing family members to take on important roles as caregivers. Therefore, the resilience of family caregivers decreases and they feel burden.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led Supportive Care Group | Experimental | Behavioral: Nurse-led Supportive Care ProgrammeNurse-led supportive care was given to family caregivers of patients with lung cancer. |
| Control Group | No intervention | –The control group received only usual care. They did not receive any intervention during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A family member who has been a primary caregiver for at least one year
- Literate
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- Have any communication disability
- Have any diagnosed physical or psychological disorder
- Receiving any supportive care
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 |
|---|---|---|
| Nurse-led Supportive Care ProgrammeNurse-led supportive care programme was applied to family caregivers for eight weeks in the form of face-to-face clinic interviews. It took an average of 40 minutes to interview with family caregivers at the clinic. | Behavioural | Nurse-led Supportive Care Group |
Primary outcome
Zarit Burden Interview (ZBI)
Time frame: The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.
The ZBI is a measure of caregiving burden developed by Zarit et al. (1980). The Turkish version of this scale has been validated by Inci and Erdem (2018). It consists of 22 items, and responses are recorded on a five-point Likert scale. The level of caregiver burden can be ascertained based on the total scale scores, which range from 0 to 88. Higher scores indicate a higher level of caregiver burden.The Cronbach's α of the Turkish version of this scale was 0.91 in Inci and Erdem (2018) validation study.
1 secondary outcome
Connor-Davidson Resilience Scale Short Form (CDRSSF)
Time frame: The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.
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 6 Aug 2024.
- Derived from this study: PubMed 41765744Karaca M, Zorba Bahceli P. The Effects of a Nurse-Led Supportive Care Program on Caregiver Burden and Family Resilience of Caregivers of Patients with Lung Cancer: A Pragmatic Randomized Controlled Trial. Semin Oncol Nurs. 2026 Aug;42(4):152171. doi: 10.1016/j.soncn.2026.152171. Epub 2026 Feb 28.
- 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.
Pinar Zorba Bahceli, PhD study director
Izmir Bakircay University Faculty of Health Sciences Izmir, Turkey, 35560
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Supportive Care Programme in people with Nurse-led Supportive Care, run by Izmir Bakircay 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 3 inclusion and 3 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 6 Aug 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?
Zarit Burden Interview (ZBI) (time frame: The scale was filled in the baseline (before the beginning of the nurse-led supportive care), 8th and 12th weeks.). 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 NCT06204289, 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 6 Aug 2024.