Palliative CareCARE-PALNCT07593729
Nurse-Led Caregiver Support Program in Home Palliative Care
A study testing Nurse-Led Caregiver Support Program in people with Palliative Care and Caregiver Burden, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated a nurse-led caregiver support program for family caregivers of patients with cancer receiving home palliative care. A total of 162 caregivers were randomly assigned to the intervention or control group, with 81 caregivers in each group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Caregiver Burden, Home Care
- What is being tested?
- Nurse-Led Caregiver Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2026to 30 Sep 2026
- 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
- Adult family caregivers of patients receiving home palliative care services
- Age 18 years or older
- Being the primary caregiver responsible for the patient's daily care
- Ability to communicate in Turkish
- Willingness to participate in the study
Who cannot join
- Professional or paid caregivers
- Caregivers with severe cognitive impairment or severe psychiatric disorders
- Inability to participate in follow-up assessments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Simav Doc. Dr. Ismail Karakuyu State Hospital
Simav, Kütahya, 43500
About this study
Official title: Effect of a Nurse-Led Caregiver Support Program on Caregiver Competency and Healthcare Utilization Among Family Caregivers in Home Palliative Care: A Randomized Controlled Trial
This randomized controlled trial evaluated a nurse-led caregiver support program for family caregivers of patients with cancer receiving home palliative care. A total of 162 caregivers were randomly assigned to the intervention or control group, with 81 caregivers in each group. The intervention included six weeks of structured education, weekly telephone coaching, caregiver guidance materials, and decision support for symptom management and healthcare use. As-needed telephone consultation remained available through week 18. Both groups received routine home care services. The primary outcome was caregiver competency. Secondary outcomes included caregiver burden, self-efficacy, patient palliative care concerns assessed using the Integrated Palliative care Outcome Scale, emergency department visits, and hospitalizations. Questionnaire assessments were conducted at baseline, week 6, and week 18.
Read the detailed description
Palliative care aims to improve quality of life for individuals with life-threatening illnesses through symptom management and holistic care. In home palliative care settings, family caregivers play a central role in daily care, symptom monitoring, and decisions about seeking healthcare. These responsibilities can place substantial demands on caregivers and create a need for structured education and support.
This single-center, parallel-group, randomized controlled trial evaluated a nurse-led caregiver support program among family caregivers of patients with cancer receiving home palliative care services. Participants were recruited from the home care unit's cancer patient population.
The planned sample size was 150 family caregivers. A total of 162 caregivers were enrolled and randomly assigned to the intervention or control group in a 1:1 ratio, with 81 caregivers in each group. Allocation used computer-generated block randomization with a block size of four. Outcome assessments were conducted by a researcher blinded to group allocation. The data analyst was also blinded to group allocation.
The intervention was delivered by a palliative care nurse with a master's degree. It comprised an initial face-to-face educational session followed by weekly telephone coaching over six weeks. Educational content addressed symptom management, daily care skills, medication management, recognition of complications, caregiver self-care, stress management, and decisions about seeking healthcare. Caregivers received a guidebook and a crisis management decision algorithm. As-needed telephone consultation remained available through week 18.
Both groups continued to receive routine services from the home care unit, including monthly home visits. The control group received no additional study-specific education or telephone coaching.
Questionnaire assessments were scheduled at baseline (T0), week 6 at the end of the structured intervention (T1), and week 18, corresponding to 12 weeks after T1 (T2). The primary outcome was caregiver competency, measured using the Care Competency Scale for Family Caregivers in Home Palliative Care. Secondary outcomes included caregiver burden, measured using the Zarit Burden Interview; self-efficacy, measured using the General Self-Efficacy Scale; and patient symptoms and other palliative care concerns, assessed using the Integrated Palliative care Outcome Scale with information provided by caregivers.
Healthcare utilization outcomes included emergency department visits and hospitalizations during the follow-up interval from week 6 to week 18. Healthcare utilization data were obtained from institutional records and cross-checked with caregiver reports.
The trial examined whether structured nurse-led education and support could improve caregiver competency and secondary caregiver and patient outcomes compared with routine home care.
- Conditions
- Palliative Care, Caregiver Burden, Home Care
- Being tested
- Nurse-Led Caregiver Support Program
- Keywords
- Nurse-led intervention, Family caregiver, Caregiver competency, Home care, Randomized controlled trial, Palliative care, Healthcare utilization
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Caregiver Support ProgramBehavioural
The program was delivered by a palliative care nurse with a master's degree. It comprised an initial face-to-face educational session and weekly telephone coaching over six weeks. Content covered symptom management, daily care skills, medication management, recognition of complications, caregiver self-care, stress management, and decisions about seeking healthcare. Participants received a caregiver guidebook and a crisis management decision algorithm. As-needed telephone consultation was available from baseline through week 18. Routine home palliative care services continued throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Caregiver Support Program | Experimental | Participants received a structured six-week nurse-led caregiver support program in addition to routine home palliative care services. The program included an initial face-to-face educational session, weekly telephone coaching, a caregiver guidebook, and a crisis management decision algorithm. As-needed telephone consultation remained available through week 18. Receives: Behavioral: Nurse-Led Caregiver Support Program |
| Routine Home Palliative Care | No intervention | Participants received routine home palliative care services, including monthly home visits by the home care unit. No additional study-specific structured education or telephone coaching was provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Competency Scale for Family Caregivers in Home Palliative Care
Caregiver competency was assessed using the Care Competency Scale for Family Caregivers in Home Palliative Care. The scale contains 29 items, each scored from 1 to 5. Total scores range from 29 to 145, with higher scores indicating greater caregiver competency.
Measured: Baseline (T0), week 6 (T1; end of the structured intervention), and week 18 (T2; 12 weeks after T1).
Secondary outcomes (5)
Zarit Burden Interview
Caregiver burden was assessed using the 22-item Zarit Burden Interview. Each item is scored from 0 to 4. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.
Measured: Baseline (T0), week 6 (T1; end of the structured intervention), and week 18 (T2; 12 weeks after T1).
General Self-Efficacy Scale
Caregiver self-efficacy was assessed using the 10-item General Self-Efficacy Scale. Each item is scored from 1 to 4. Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.
Measured: Baseline (T0), week 6 (T1; end of the structured intervention), and week 18 (T2; 12 weeks after T1).
Integrated Palliative Care Outcome Scale
Patient symptoms and other palliative care concerns were assessed using the Turkish staff version of the Integrated Palliative care Outcome Scale (IPOS), completed by the outcome assessor using information provided by the family caregiver. The recall period was the previous seven days. The 17 scored items yield a total score ranging from 0 to 68, with higher scores indicating greater symptom burden and other palliative care concerns.
Measured: Baseline (T0), week 6 (T1; end of the structured intervention), and week 18 (T2; 12 weeks after T1).
Emergency Department Visits
Number of emergency department visits made by the patient during the follow-up interval between T1 and T2. Visits were ascertained from institutional records and cross-checked with caregiver reports. Higher counts indicate greater emergency department use.
Measured: From week 6 (T1) to week 18 (T2).
Hospitalizations
Number of hospital admissions experienced by the patient during the follow-up interval between T1 and T2. Admissions were ascertained from institutional records and cross-checked with caregiver reports. Higher counts indicate greater inpatient healthcare use.
Measured: From week 6 (T1) to week 18 (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start12 May 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Palliative 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
- Model description
- This was a two-arm, parallel-group randomized controlled trial. A total of 162 family caregivers were assigned to the intervention or control group in a 1:1 ratio (81 per group), using computer-generated block randomization with a block size of four.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593729
- Sponsor's protocol ID
- KSBU-HPC-RCT-2026-01
- Acronym
- CARE-PAL
- Status last verified
- Oct 2026
- First submitted
- 11 May 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because of concerns about participant confidentiality and the potential re-identification of patients and family caregivers in this single-center study. Study findings will be reported in aggregate form in scientific publications.
Publications
Karabulutlu EY, Turan GB, Yanmis S. Evaluation of care burden and preparedness of caregivers who provide care to palliative care patients. Palliat Support Care. 2022 Feb;20(1):30-37. doi: 10.1017/S1478951521000213.
PubMed 33785083Wang T, Kong J, Chen X, Yang Y, Liu D, Liu T, Li L. Development and psychometric assessment of a care competency scale for family caregivers in home palliative care. Asia Pac J Oncol Nurs. 2025 May 10;12:100719. doi: 10.1016/j.apjon.2025.100719. eCollection 2025 Dec.
PubMed 40521035Zhang Y, Li J, Zhang Y, Chen C, Guan C, Zhou L, Zhang S, Chen X, Hu X. Mediating effect of social support between caregiver burden and quality of life among family caregivers of cancer patients in palliative care units. Eur J Oncol Nurs. 2024 Feb;68:102509. doi: 10.1016/j.ejon.2024.102509. Epub 2024 Jan 15.
PubMed 38310666
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nurse-Led Caregiver Support Program on Caregiver Competency and Healthcare Utilization Among Family Caregivers in Home Palliative Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07593729
- Acronym / sponsor ID
- CARE-PAL / KSBU-HPC-RCT-2026-01
- Conditions
- Palliative Care, Caregiver Burden, Home Care
- Keywords
- Nurse-led intervention, Family caregiver, Caregiver competency, Home care, Randomized controlled trial, Palliative care, Healthcare utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 18 May 2026 (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.
This randomized controlled trial evaluated a nurse-led caregiver support program for family caregivers of patients with cancer receiving home palliative care. A total of 162 caregivers were randomly assigned to the intervention or control group, with 81 caregivers in each group. The intervention included six weeks of structured education, weekly telephone coaching, caregiver guidance materials, and decision support for symptom management and healthcare use. As-needed telephone consultation remained available through week 18. Both groups received routine home care services. The primary outcome was caregiver competency. Secondary outcomes included caregiver burden, self-efficacy, patient palliative care concerns assessed using the Integrated Palliative care Outcome Scale, emergency department visits, and hospitalizations. Questionnaire assessments were conducted at baseline, week 6, and week 18.
Detailed description
Palliative care aims to improve quality of life for individuals with life-threatening illnesses through symptom management and holistic care. In home palliative care settings, family caregivers play a central role in daily care, symptom monitoring, and decisions about seeking healthcare. These responsibilities can place substantial demands on caregivers and create a need for structured education and support.
This single-center, parallel-group, randomized controlled trial evaluated a nurse-led caregiver support program among family caregivers of patients with cancer receiving home palliative care services. Participants were recruited from the home care unit's cancer patient population.
The planned sample size was 150 family caregivers. A total of 162 caregivers were enrolled and randomly assigned to the intervention or control group in a 1:1 ratio, with 81 caregivers in each group. Allocation used computer-generated block randomization with a block size of four. Outcome assessments were conducted by a researcher blinded to group allocation. The data analyst was also blinded to group allocation.
The intervention was delivered by a palliative care nurse with a master's degree. It comprised an initial face-to-face educational session followed by weekly telephone coaching over six weeks. Educational content addressed symptom management, daily care skills, medication management, recognition of complications, caregiver self-care, stress management, and decisions about seeking healthcare. Caregivers received a guidebook and a crisis management decision algorithm. As-needed telephone consultation remained available through week 18.
Both groups continued to receive routine services from the home care unit, including monthly home visits. The control group received no additional study-specific education or telephone coaching.
Questionnaire assessments were scheduled at baseline (T0), week 6 at the end of the structured intervention (T1), and week 18, corresponding to 12 weeks after T1 (T2). The primary outcome was caregiver competency, measured using the Care Competency Scale for Family Caregivers in Home Palliative Care. Secondary outcomes included caregiver burden, measured using the Zarit Burden Interview; self-efficacy, measured using the General Self-Efficacy Scale; and patient symptoms and other palliative care concerns, assessed using the Integrated Palliative care Outcome Scale with information provided by caregivers.
Healthcare utilization outcomes included emergency department visits and hospitalizations during the follow-up interval from week 6 to week 18. Healthcare utilization data were obtained from institutional records and cross-checked with caregiver reports.
The trial examined whether structured nurse-led education and support could improve caregiver competency and secondary caregiver and patient outcomes compared with routine home care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This was a two-arm, parallel-group randomized controlled trial. A total of 162 family caregivers were assigned to the intervention or control group in a 1:1 ratio (81 per group), using computer-generated block randomization with a block size of four.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Caregiver Support Program | Experimental | Behavioral: Nurse-Led Caregiver Support ProgramParticipants received a structured six-week nurse-led caregiver support program in addition to routine home palliative care services. The program included an initial face-to-face educational session, weekly telephone coaching, a caregiver guidebook, and a crisis management decision algorithm. As-needed telephone consultation remained available through week 18. |
| Routine Home Palliative Care | No intervention | –Participants received routine home palliative care services, including monthly home visits by the home care unit. No additional study-specific structured education or telephone coaching was provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult family caregivers of patients receiving home palliative care services
- Age 18 years or older
- Being the primary caregiver responsible for the patient's daily care
- Ability to communicate in Turkish
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- Professional or paid caregivers
- Caregivers with severe cognitive impairment or severe psychiatric disorders
- Inability to participate in follow-up assessments
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 Caregiver Support ProgramThe program was delivered by a palliative care nurse with a master's degree. It comprised an initial face-to-face educational session and weekly telephone coaching over six weeks. Content covered symptom management, daily care skills, medication management, recognition of complications, caregiver self-care, stress management, and decisions about seeking healthcare. Participants received a caregiver guidebook and a crisis management decision algorithm. As-needed telephone consultation was available from baseline through week 18. Routine home palliative care services continued throughout the study. | Behavioural | Nurse-Led Caregiver Support Program |
Primary outcome
Care Competency Scale for Family Caregivers in Home Palliative Care
Time frame: Baseline (T0), week 6 (T1; end of the structured intervention), and week 18 (T2; 12 weeks after T1).
Caregiver competency was assessed using the Care Competency Scale for Family Caregivers in Home Palliative Care. The scale contains 29 items, each scored from 1 to 5. Total scores range from 29 to 145, with higher scores indicating greater caregiver competency.
5 secondary outcomes
Zarit Burden Interview
Time frame: Baseline (T0), week 6 (T1; end of the structured intervention), and week 18 (T2; 12 weeks after T1).
General Self-Efficacy Scale
Time frame: Baseline (T0), week 6 (T1; end of the structured intervention), and week 18 (T2; 12 weeks after T1).
Integrated Palliative Care Outcome Scale
Time frame: Baseline (T0), week 6 (T1; end of the structured intervention), and week 18 (T2; 12 weeks after T1).
Emergency Department Visits
Time frame: From week 6 (T1) to week 18 (T2).
Hospitalizations
Time frame: From week 6 (T1) to week 18 (T2).
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 14 Oct 2026.
- Background: PubMed 33785083Karabulutlu EY, Turan GB, Yanmis S. Evaluation of care burden and preparedness of caregivers who provide care to palliative care patients. Palliat Support Care. 2022 Feb;20(1):30-37. doi: 10.1017/S1478951521000213.
- Background: PubMed 40521035Wang T, Kong J, Chen X, Yang Y, Liu D, Liu T, Li L. Development and psychometric assessment of a care competency scale for family caregivers in home palliative care. Asia Pac J Oncol Nurs. 2025 May 10;12:100719. doi: 10.1016/j.apjon.2025.100719. eCollection 2025 Dec.
- Background: PubMed 38310666Zhang Y, Li J, Zhang Y, Chen C, Guan C, Zhou L, Zhang S, Chen X, Hu X. Mediating effect of social support between caregiver burden and quality of life among family caregivers of cancer patients in palliative care units. Eur J Oncol Nurs. 2024 Feb;68:102509. doi: 10.1016/j.ejon.2024.102509. Epub 2024 Jan 15.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because of concerns about participant confidentiality and the potential re-identification of patients and family caregivers in this single-center study. Study findings will be reported in aggregate form in scientific publications.
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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 Nurse-Led Caregiver Support Program in people with Palliative Care and Caregiver Burden, run by Kutahya Health Sciences 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 5 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 14 Oct 2026. 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?
Care Competency Scale for Family Caregivers in Home Palliative Care (time frame: Baseline (T0), week 6 (T1; end of the structured intervention), and week 18 (T2; 12 weeks after T1).). 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 NCT07593729, which also lists 3 linked publications.
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 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.