Palliative CareCOPE-PALNCT07749339
Coping Psychoeducation for Family Caregivers of Palliative Care Patients
A study testing coping psychoeducation program and Routine Care in people with Palliative Care and Caregiver Burden, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
This quasi-experimental study aims to evaluate the effectiveness of a six-week, nurse-led structured coping psychoeducation program for family caregivers of patients receiving palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Caregiver Burden, Burnout
- What is being tested?
- coping psychoeducation program and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2025to 20 Jun 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
- Family member serving as the primary caregiver of a patient admitted to the palliative care unit.
- Aged 18 years or older. No diagnosed psychiatric disorder. Willing to participate in the study and provide informed consent. Able to attend the psychoeducation program regularly. Caregivers of patients admitted to Palliative Care Unit 1 were assigned to the experimental group.
- Caregivers of patients admitted to Palliative Care Unit 2 were assigned to the control group.
Who cannot join
- Previous participation in any psychoeducation or training program related to palliative care caregiving.
- Inability to complete the psychoeducation program or post-intervention assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: " The Effect of a Nursing-Led Coping Psychoeducation Program Applied to Family Caregivers of Palliative Care Patients on Care Burden, Coping Strategies and Burnout Level: A Quasi-Experimental Study''
This quasi-experimental study aims to evaluate the effectiveness of a six-week, nurse-led structured coping psychoeducation program for family caregivers of patients receiving palliative care. The study will examine the effects of the intervention on caregiver burden, coping strategies, and burnout using pre- and post-intervention assessments.
Read the detailed description
Objective:
The objective of this study is to evaluate the effectiveness of a nurse-led coping psychoeducation program on caregiver burden, coping strategies, and burnout among family caregivers of patients receiving palliative care.
Study Design:
This study uses a quasi-experimental pretest-posttest design with an intervention group and a control group.
Intervention:
Participants assigned to the intervention group (n = 20) will receive a six-week, nurse-led psychoeducation program consisting of 12 structured sessions designed to improve stress management and coping skills. Participants in the control group will receive routine care during the study period.
Outcome Measures:
The primary outcomes include caregiver burden, coping strategies, and burnout. Data will be collected before and after the intervention using the Caregiver Information Form, the Zarit Burden Interview (ZBI), the Maslach Burnout Inventory (MBI), and the Stress Coping Styles Scale (SCSS).
Statistical Analysis:
Data will be analyzed using IBM SPSS Statistics version 22.0 and Python 3. Descriptive statistics will be used to summarize participant characteristics. Between-group and within-group comparisons will be conducted using appropriate parametric or nonparametric statistical tests. Analysis of covariance (ANCOVA) will be used to adjust for baseline differences, and generalized estimating equations (GEE) will be applied to evaluate changes over time. Statistical significance will be determined at a two-sided p value of <0.05.
- Conditions
- Palliative Care, Caregiver Burden, Burnout, Family Caregivers
- Being tested
- coping psychoeducation program, Routine Care
- Keywords
- Palliative Care, caregiver, psychoeducation, coping with stress
- Medical subject headings
- Caregiver Burden, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coping psychoeducation programBehavioural
A nurse-led structured coping psychoeducation program was delivered to family caregivers of palliative care patients over 6 weeks. The intervention consisted of 12 sessions, including an introductory meeting and weekly psychoeducation sessions focusing on palliative care, the caregiving role, stress and burnout, coping strategies, emotional regulation, relaxation techniques, self-care, communication, social support, problem-solving, resilience, and program evaluation. Sessions lasted approximately 40-60 minutes and were conducted in small groups using lectures, discussions, role-playing, case-based learning, practical exercises, and feedback. All participants in the intervention group also continued to receive routine palliative care services.
Routine CareOther
Family caregivers received the routine care and education provided by the palliative care unit. No structured coping psychoeducation program was delivered during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Nurse-Led Coping Psychoeducation Program | Experimental | Participants received a nurse-led structured coping psychoeducation program consisting of 12 sessions delivered over 6 weeks (two sessions per week, approximately 60-90 minutes per session). The program included psychoeducation on stress, coping strategies, communication, emotional regulation, problem-solving, relaxation techniques, and social support. Participants also continued to receive routine palliative care services. Receives: Behavioral: coping psychoeducation program |
| Arm Title: Routine Care | Experimental | Participants received routine palliative care services provided by the institution. No structured psychoeducation or additional intervention was delivered during the study period. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiving burden will be assessed using the Zarit Burden Interview (ZBI). The ZBI is a validated self-report instrument that evaluates the perceived burden experienced by family caregivers. Higher scores indicate greater caregiving burden.
Baseline (before the intervention) and immediately after completion of the 6-week intervention.
Measured: At baseline and immediately after completion of the 6-week intervention
Secondary outcomes (1)
Coping Strategies
Coping strategies will be assessed using the Stress Coping Styles Scale (SCSS). The scale evaluates adaptive coping (self-confident, optimistic, and social support-seeking approaches) and maladaptive coping (helpless and submissive approaches). Higher scores on adaptive coping and lower scores on maladaptive coping indicate improved coping strategies.
Measured: At baseline and immediately after completion of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start23 Nov 2025
- Primary completion20 Feb 2026
- Study completion20 Jun 2026
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 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 study is a quasi-experimental, pretest-posttest controlled study. Family caregivers of patients hospitalized in two separate palliative care units at Kastamonu Training and Research Hospital were allocated according to the unit of hospitalization. Caregivers of patients in Palliative Care Unit 1 received the nurse-led coping psychoeducation program (intervention group), while caregivers of patients in Palliative Care Unit 2 received routine care (control group). Outcomes were assessed before the intervention and after completion of the psychoeducation program.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Kaçan, Kastamonu University
- Investigators
- Havva KAÇAN, associate professor, Principal investigator, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749339
- Sponsor's protocol ID
- KAEK-121 2026-29
- Acronym
- COPE-PAL
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the informed consent obtained from participants did not include permission for public data sharing, and sharing individual-level data could compromise participant confidentiality and privacy.
Publications
Valero-Cantero I, Casals C, Espinar-Toledo M, Baron-Lopez FJ, Martinez-Valero FJ, Garcia-Agua Soler N, Vazquez-Sanchez MA. Effect of Self-Chosen Music in Alleviating the Burden on Family Caregivers of Patients with Advanced Cancer: A Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Mar 6;20(5):4662. doi: 10.3390/ijerph20054662.
PubMed 36901671
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " The Effect of a Nursing-Led Coping Psychoeducation Program Applied to Family Caregivers of Palliative Care Patients on Care Burden, Coping Strategies and Burnout Level: A Quasi-Experimental Study''
- ClinicalTrials.gov ID
- NCT07749339
- Acronym / sponsor ID
- COPE-PAL / KAEK-121 2026-29
- Conditions
- Palliative Care, Caregiver Burden, Burnout, Family Caregivers
- Keywords
- Palliative Care, caregiver, psychoeducation, coping with stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 23 Nov 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 6 Aug 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 quasi-experimental study aims to evaluate the effectiveness of a six-week, nurse-led structured coping psychoeducation program for family caregivers of patients receiving palliative care. The study will examine the effects of the intervention on caregiver burden, coping strategies, and burnout using pre- and post-intervention assessments.
Detailed description
Objective:
The objective of this study is to evaluate the effectiveness of a nurse-led coping psychoeducation program on caregiver burden, coping strategies, and burnout among family caregivers of patients receiving palliative care.
Study Design:
This study uses a quasi-experimental pretest-posttest design with an intervention group and a control group.
Intervention:
Participants assigned to the intervention group (n = 20) will receive a six-week, nurse-led psychoeducation program consisting of 12 structured sessions designed to improve stress management and coping skills. Participants in the control group will receive routine care during the study period.
Outcome Measures:
The primary outcomes include caregiver burden, coping strategies, and burnout. Data will be collected before and after the intervention using the Caregiver Information Form, the Zarit Burden Interview (ZBI), the Maslach Burnout Inventory (MBI), and the Stress Coping Styles Scale (SCSS).
Statistical Analysis:
Data will be analyzed using IBM SPSS Statistics version 22.0 and Python 3. Descriptive statistics will be used to summarize participant characteristics. Between-group and within-group comparisons will be conducted using appropriate parametric or nonparametric statistical tests. Analysis of covariance (ANCOVA) will be used to adjust for baseline differences, and generalized estimating equations (GEE) will be applied to evaluate changes over time. Statistical significance will be determined at a two-sided p value of <0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This study is a quasi-experimental, pretest-posttest controlled study. Family caregivers of patients hospitalized in two separate palliative care units at Kastamonu Training and Research Hospital were allocated according to the unit of hospitalization. Caregivers of patients in Palliative Care Unit 1 received the nurse-led coping psychoeducation program (intervention group), while caregivers of patients in Palliative Care Unit 2 received routine care (control group). Outcomes were assessed before the intervention and after completion of the psychoeducation program.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Nurse-Led Coping Psychoeducation Program | Experimental | Behavioral: coping psychoeducation programParticipants received a nurse-led structured coping psychoeducation program consisting of 12 sessions delivered over 6 weeks (two sessions per week, approximately 60-90 minutes per session). The program included psychoeducation on stress, coping strategies, communication, emotional regulation, problem-solving, relaxation techniques, and social support. Participants also continued to receive routine palliative care services. |
| Arm Title: Routine Care | Experimental | Other: Routine CareParticipants received routine palliative care services provided by the institution. No structured psychoeducation or additional intervention was delivered during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Family member serving as the primary caregiver of a patient admitted to the palliative care unit.
- Aged 18 years or older. No diagnosed psychiatric disorder. Willing to participate in the study and provide informed consent. Able to attend the psychoeducation program regularly. Caregivers of patients admitted to Palliative Care Unit 1 were assigned to the experimental group.
- Caregivers of patients admitted to Palliative Care Unit 2 were assigned to the control group.
Key exclusion criteria (2 listed)
- Previous participation in any psychoeducation or training program related to palliative care caregiving.
- Inability to complete the psychoeducation program or post-intervention 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 |
|---|---|---|
| coping psychoeducation programA nurse-led structured coping psychoeducation program was delivered to family caregivers of palliative care patients over 6 weeks. The intervention consisted of 12 sessions, including an introductory meeting and weekly psychoeducation sessions focusing on palliative care, the caregiving role, stress and burnout, coping strategies, emotional regulation, relaxation techniques, self-care, communication, social support, problem-solving, resilience, and program evaluation. Sessions lasted approximately 40-60 minutes and were conducted in small groups using lectures, discussions, role-playing, case-based learning, practical exercises, and feedback. All participants in the intervention group also continued to receive routine palliative care services. | Behavioural | Experimental: Nurse-Led Coping Psychoeducation Program |
| Routine CareFamily caregivers received the routine care and education provided by the palliative care unit. No structured coping psychoeducation program was delivered during the study period. | Other | Arm Title: Routine Care |
Primary outcome
Caregiving burden will be assessed using the Zarit Burden Interview (ZBI). The ZBI is a validated self-report instrument that evaluates the perceived burden experienced by family caregivers. Higher scores indicate greater caregiving burden.
Time frame: At baseline and immediately after completion of the 6-week intervention
Baseline (before the intervention) and immediately after completion of the 6-week intervention.
1 secondary outcome
Coping Strategies
Time frame: At baseline and immediately after completion of the 6-week intervention
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 2026.
- Background: PubMed 36901671Valero-Cantero I, Casals C, Espinar-Toledo M, Baron-Lopez FJ, Martinez-Valero FJ, Garcia-Agua Soler N, Vazquez-Sanchez MA. Effect of Self-Chosen Music in Alleviating the Burden on Family Caregivers of Patients with Advanced Cancer: A Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Mar 6;20(5):4662. doi: 10.3390/ijerph20054662.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the informed consent obtained from participants did not include permission for public data sharing, and sharing individual-level data could compromise participant confidentiality and privacy.
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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.
Havva KAÇAN, associate professor principal investigator
Kastamonu 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 coping psychoeducation program and Routine Care in people with Palliative Care and Caregiver Burden, run by Kastamonu 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 2 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 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?
Caregiving burden will be assessed using the Zarit Burden Interview (ZBI). The ZBI is a validated self-report instrument that evaluates the perceived burden experienced by family caregivers. Higher scores indicate greater caregiving burden. (time frame: At baseline and immediately after completion of the 6-week intervention). 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 NCT07749339, 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 2026.