Effects of a Psycho-educational Intervention for Family Caregivers in Palliative Care

NCT02482415 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2016-08-05

No results posted yet for this study

Summary

Health care systems are increasingly using outpatient care for patients with advanced cancer disease with complex needs, limited life expectancy, and need for palliative care. Family caregivers are centrally important, but are often insufficiently prepared for the caregiving role, and experience psychological distress and physical symptoms. We hypothesize that a psycho-educational intervention during ongoing palliative care will support family caregivers' wellbeing and decrease negative consequences of caregiving.

The intervention, which has been developed in steps through a series of studies based on theoretical, methodological, and empirical work, was delivered in a group format 2013-2014. Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each meeting had a specific topic presented by a member of the palliative care team (physician, nurse, and social worker). The meetings addressed multi-dimensional issues in dialogue with the participants.

The overall aim of this ongoing project is to investigate short and long-term effects of the intervention delivered by health professionals at ten specialized palliative home care units. Multiple methods are now being used, including a randomized controlled trial (RCT). In total, 270 family caregivers have been requested to answer a questionnaire at four time points: at baseline, upon completion and again 2 months after completion of the intervention, and 6 months after the patient's death. The primary outcome variable is preparedness for caregiving, and the secondary outcome variables cover aspects of wellbeing including competence and reward, caregiver burden, health, anxiety and depressive symptoms, and grief. These data will be complemented with interviews.

The project has the potential to contribute knowledge about the development of support for family caregivers, not only in specialized palliative care but also in other contexts such as elderly care and general home care services.

Conditions

Interventions

OTHER

Psycho-educational

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER
  • Linnaeus University

    collaborator OTHER
  • Lund University

    collaborator OTHER
  • Ersta Sköndal University College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-12-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02482415 on ClinicalTrials.gov