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

NCT02482415 | Unknown

• 1 other identifier: 130121
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief 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

Cancer

Keywords

Palliative Care; Randomized controlled trial; Family caregivers; Intervention; Family; Intervention studies; Home Care

Outcome Measures

Primary Outcomes (2)

• Change in the PCS 5 weeks and 13 weeks after baseline

  The PCS is designed to measure caregivers' perceived readiness to provide care in real time. It consists of eight items answered on a five-point Likert-type response scale ranging from 'not at all prepared' (0) to 'very well prepared' (4) with a total score ranging from 0-32.

  Baseline, 5 weeks, 13 weeks

• TRIG

  TRIG measures complicated grief on a 5 Point likert type scale ranging from 1 (Completely true) to 5 (Completely false).

  6 months after the patient's death

Study Arms (2)

Intervention

EXPERIMENTAL

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 health care professional of the palliative care team (physician, nurse and social worker). The meetings addressed multi-dimensional issues in dialogue with the participants. A nurse acted as group leader and participated in all meetings. The intervention included both supportive and educational components. Each meeting began with a presentation based on a specific topic (palliative care, practical care and emotional reactions). This was followed by reflection and conversation, and finally a relaxation exercise

Other: Psycho-educational

Control

NO INTERVENTION

Interventions

Psycho-educational OTHER

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being family caregiver to a person in specialized palliative home care,
• Over the age of 18, and
• Able to read and understand Swedish.

You may not qualify if:

• None.

Sponsors & Collaborators

• Ersta Sköndal University College: lead
• Karolinska Institutet: collaborator
• Linnaeus University: collaborator
• Lund University: collaborator

Related Publications (1)

• Holm M, Arestedt K, Carlander I, Wengstrom Y, Ohlen J, Alvariza A. Characteristics of the Family Caregivers Who Did Not Benefit From a Successful Psychoeducational Group Intervention During Palliative Cancer Care: A Prospective Correlational Study. Cancer Nurs. 2017 Jan/Feb;40(1):76-83. doi: 10.1097/NCC.0000000000000351.

  PMID: 26925988 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, lecturer in Palliative Care

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 26, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2016-08