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

NCT03200730 | Unknown DMC

• 1 other identifier: IRB-2017-02-019
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Family Dignity Intervention; Multicentre Randomized Control Trial; Palliative Care; End-of-Life Care

Outcome Measures

Primary Outcomes (2)

• Change from Baseline 'Patient Dignity Inventory (PDI)' at 14 days [T2] and 4 weeks [T3] follow-up.

  This 25-item measure evolved directly from the dignity model and comprised of questions relevant to the physical, psychosocial, existential and spiritual domain of end-of-life concern or distress.

  For patients, it will be assessed at baseline [T1], 14 days [T2] and four weeks [T3] follow-up.

• Change from Baseline 'Patient Health Questionnaire' at 14 days [T2] and 4 week [T3] follow-up, and 2 months [T4] post bereavement.

  This 9-item questionnaire measures patients' psychological distress.

  For Caregivers, it will be assessed at baseline [T1], 14 days [T2] and four weeks [T3] follow-up, as well as two months [T4] following bereavement.

Secondary Outcomes (9)

• Change from Baseline 'Patient Health Questionnaire' at T2 and T3.

  For patients, this will be assessed at baseline [T1], 14 days [T2] and four weeks [T3] follow-up.

• Change from Baseline 'Caregiver Self-Assessment' at T2, T3 and T4.

  For Caregivers, this will be assessed at baseline [T1], two weeks [T2] and eight weeks [T3] follow-up, as well as two months [T4] following bereavement.

• Change from Baseline 'Cancer Coherence Scale' at T2, T3 and T4.

  For Patients, this will be assessed at baseline [T1], 14 days [T2] and four weeks [T3] follow-up. For Caregivers, this will be assessed at baseline [T1], two weeks [T2] and four weeks [T3] follow-up, as well as two months [T4] following bereavement.

• Change from Baseline 'World Health Organization Quality of Life Scale-8' at T2, T3 and T4.

  For Patients, this will be assessed at baseline [T1], 14 days [T2] and four weeks [T3] follow-up. For Caregivers, this will be assessed at baseline [T1], two weeks [T2] and four weeks [T3] follow-up, as well as two months [T4] following bereavement.

• Change from Baseline 'FACIT Spiritual Well-being Scale' at T2, T3 and T4.

  For Patients, this will be assessed at baseline [T1], 14 days [T2] and four weeks [T3] follow-up. For Caregivers, this will be assessed at baseline [T1], two weeks [T2] and four weeks [T3] follow-up, as well as two months [T4] following bereavement.

Study Arms (2)

Family Dignity Intervention group

EXPERIMENTAL

A standard framework of 12 FDI questions is given to patient-family dyads in the intervention group during baseline to provides them with the opportunity to think about their responses. During the intervention interview scheduled 2-3 days later, the FDI therapist follows that dyad's cues, help them to organize their thoughts, facilitate disclosure of cherished memories, and encourage the expression of appreciation. The interview is be recorded, quickly transcribed verbatim then edited into a coherent narrative. A second review session is arranged to review and finalize the edited transcript with the dyads. Once the "legacy" documents are ready, a final family sharing session is arranged for the dyads to share and read this document to each other and their loved ones.

Behavioral: Family Dignity Intervention group

Control group

NO INTERVENTION

Patient-family dyads in the control group have at least four interviews with a designated member of the research team via psychosocial home visits. Completing the assessments and taking part in the interviews provides them with the opportunity to share their feelings and emotions along their illness trajectory. The extent to which they feel sharing is therapeutic is explored in the interview.

Interventions

Family Dignity Intervention group BEHAVIORAL

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.

Family Dignity Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Terminally-ill patients with a life expectancy of no more than 6 months
• Living in the community and receiving hospice home-and-day care services, OR, residing in long-term-care or hospice facilities and receiving hospice palliative care
• Score 30 and above on Karnofsky Performance Status Scale
• Score 18 and above on Mini-Mental State Examination (MMSE)
• Able to speak English, Mandarin, or Cantonese

You may not qualify if:

• Too ill to participate
• Unable to provide informed consent either due to cognitive problems or severity of illness
• Perform poorly on Karnofsky Performance Status Scale (i.e., scoring less than 30)
• Perform poorly on MMSE (i.e., scoring less than 18)
• Having moderate or severe cognitive impairment
• Unable to understand English, Mandarin, or Cantonese

Sponsors & Collaborators

• Nanyang Technological University: lead
• HCA Hospice Care: collaborator
• Dover Park Hospice Singapore: collaborator
• National Cancer Centre, Singapore: collaborator
• University of Manitoba: collaborator
• University of Memphis: collaborator

Study Sites (2)

Dover Park Hospice Care

Singapore, 308436, Singapore

RECRUITING

HCA Hospice Care

Singapore, 308437, Singapore

RECRUITING

Related Publications (5)

• Ho AH, Chan CL, Leung PP, Chochinov HM, Neimeyer RA, Pang SM, Tse DM. Living and dying with dignity in Chinese society: perspectives of older palliative care patients in Hong Kong. Age Ageing. 2013 Jul;42(4):455-61. doi: 10.1093/ageing/aft003. Epub 2013 Feb 25.

  PMID: 23443510 BACKGROUND

• Ho AH, Leung PP, Tse DM, Pang SM, Chochinov HM, Neimeyer RA, Chan CL. Dignity amidst liminality: healing within suffering among Chinese terminal cancer patients. Death Stud. 2013 Nov-Dec;37(10):953-70. doi: 10.1080/07481187.2012.703078.

  PMID: 24517523 BACKGROUND

• Chochinov HM, Hack T, Hassard T, Kristjanson LJ, McClement S, Harlos M. Dignity therapy: a novel psychotherapeutic intervention for patients near the end of life. J Clin Oncol. 2005 Aug 20;23(24):5520-5. doi: 10.1200/JCO.2005.08.391.

  PMID: 16110012 BACKGROUND

• Chochinov HM, Hack T, McClement S, Kristjanson L, Harlos M. Dignity in the terminally ill: a developing empirical model. Soc Sci Med. 2002 Feb;54(3):433-43. doi: 10.1016/s0277-9536(01)00084-3.

  PMID: 11824919 BACKGROUND

• Ho AHY, Car J, Ho MR, Tan-Ho G, Choo PY, Patinadan PV, Chong PH, Ong WY, Fan G, Tan YP, Neimeyer RA, Chochinov HM. A novel Family Dignity Intervention (FDI) for enhancing and informing holistic palliative care in Asia: study protocol for a randomized controlled trial. Trials. 2017 Dec 4;18(1):587. doi: 10.1186/s13063-017-2325-5.

  PMID: 29202863 DERIVED

Study Officials

• Andy Ho, PhD, EdD

  Nanyang Technological University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andy Ho, PhD, EdD

CONTACT

+65 63168943; andyhyho@ntu.edu.sg

Geraldine Tan-Ho, Msoc.Sc

CONTACT

+6565923677; geraldinetan@ntu.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomization will be conducted by an independent statistician. Treatment allocation (Family-oriented Dignity Intervention or Control) will be performed by block randomization with a fixed block size of two; each block will comprise of two patients with comparable terminal illness, along with their family caregiver, to reduce potential confounding effects of different illness types. Allocation concealment is facilitated by using sequentially number opaque sealed envelopes for consecutive and eligible families. To reduce the risk of bias, the researcher opens the next envelope to ascertain which group the family has been allocated to after baseline measures have been collected.

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: June 27, 2017
• Study Start: July 1, 2017
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)