A Novel Family Dignity Intervention (FDI) for Asian Palliative Care

NCT03200730 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2018-03-29

No results posted yet for this study

Summary

Background: The lack of a holistic approach to palliative care can lead to a fractured sense of dignity at the end of life, resulting in depression, hopelessness, feelings of being a burden to others, and the loss of will to live among terminally-ill patients. Building on the clinical foundation of Dignity Therapy, together with the empirical understanding of dignity-related concerns of Asian families facing terminal-illness, a novel Family Dignity Intervention (FDI) has been developed for Asia palliative care. FDI comprises a recorded interview with a patient and his/her primary family caregiver, which is transcribed, edited into a legacy document, and return to the dyads for sharing with the rest of the patient's family. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of FDI in reducing psychosocial, emotional, spiritual, and psychophysiological distress in community-dwelling and in-patient Asian older terminally-ill patients and their families living in Singapore.

Methods/Design: An open-label multicentre randomized controlled trial. 126 patient-family dyads are randomly allocated to one of two groups: (i) intervention group (FDI offered in addition to standard psychological care), and (ii) control group (standard psychological care). Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline, three days and two week after intervention, and during an exit interview with family caregivers at two month post bereavement. Primary outcome measures include sense of dignity for patients and psychological distress for caregivers. Secondary outcomes include meaning in life, quality of life, spirituality, hopefulness, perceived support and psychophysiological well-being, as well as bereavement outcomes for caregivers. Qualitative data are analyzed using Framework method.

Discussion: To date, there is no available palliative care intervention for dignity enhancement in Asia. This first-of-its kind study develops and tests an evidence-based, family-driven psycho-socio-spiritual intervention for enhancing dignity and wellbeing among Asian patients and families facing mortality. It address a critical gap in the provision of holistic palliative care. The expected outcomes will contribute to advancements in both theories and practices of palliative care for Singapore and other Asian communities around the world.

Conditions

  • Palliative Care

Interventions

BEHAVIORAL

Family Dignity Intervention group

A brief psychotherapeutic intervention offered to a family dyad (i.e., patient and one identified family caregiver) using narrative approach with life review elements. The purpose is to facilitate an open dialogue between the family dyad that strengthens family connectedness and emotional connection.

Sponsors & Collaborators

  • HCA Hospice Care

    collaborator OTHER
  • Dover Park Hospice Singapore

    collaborator UNKNOWN
  • National Cancer Centre, Singapore

    collaborator OTHER
  • University of Manitoba

    collaborator OTHER
  • University of Memphis

    collaborator OTHER
  • Nanyang Technological University

    lead OTHER

Principal Investigators

  • Andy Ho, PhD, EdD · Nanyang Technological University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • Singapore

Study Locations

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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 NCT03200730 on ClinicalTrials.gov