NCT07749339

Brief 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. The study will examine the effects of the intervention on caregiver burden, coping strategies, and burnout using pre- and post-intervention assessments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 24, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
Last Updated

August 6, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 24, 2026

Last Update Submit

August 1, 2026

Conditions

Keywords

Palliative Carecaregiverpsychoeducationcoping with stress

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline and immediately after completion of the 6-week intervention

Secondary Outcomes (1)

  • Coping Strategies

    At baseline and immediately after completion of the 6-week intervention

Study Arms (2)

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.

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.

Other: Routine Care

Interventions

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.

Experimental: Nurse-Led Coping Psychoeducation Program

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.

Arm Title: Routine Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous participation in any psychoeducation or training program related to palliative care caregiving.
  • Inability to complete the psychoeducation program or post-intervention assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu Unıversıty

Kastamonu, Merkez, 37100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 36901671BACKGROUND

MeSH Terms

Conditions

Caregiver BurdenBurnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Havva KAÇAN, associate professor

    Kastamonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
No masking was used because the behavioral psychoeducation intervention did not permit blinding of participants or the intervention provider.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

August 6, 2026

Study Start

November 23, 2025

Primary Completion

February 20, 2026

Study Completion

June 20, 2026

Last Updated

August 6, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations