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

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ClinicalTrials.gov Identifier: NCT03200730
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
HCA Hospice Care Singapore
Dover Park Hospice Singapore
National Cancer Centre, Singapore
University of Manitoba
University of Memphis
Information provided by (Responsible Party):
Andy Hau Yan Ho, PhD, EdD, Nanyang Technological University

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.


Condition or disease Intervention/treatment Phase
Palliative Care Behavioral: Family Dignity Intervention group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Multicenter Randomized Controlled Trial of a Novel Family Dignity Intervention (FDI) for Asian Palliative Care
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Family Dignity Intervention group
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
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.

No Intervention: Control group
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.



Primary Outcome Measures :
  1. Change from Baseline 'Patient Dignity Inventory (PDI)' at 14 days [T2] and 4 weeks [T3] follow-up. [ Time Frame: For patients, it will be assessed at baseline [T1], 14 days [T2] and four 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.

  2. Change from Baseline 'Patient Health Questionnaire' at 14 days [T2] and 4 week [T3] follow-up, and 2 months [T4] post bereavement. [ Time Frame: 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. ]
    This 9-item questionnaire measures patients' psychological distress.


Secondary Outcome Measures :
  1. Change from Baseline 'Patient Health Questionnaire' at T2 and T3. [ Time Frame: For patients, this will be assessed at baseline [T1], 14 days [T2] and four weeks [T3] follow-up. ]
    This 9-item questionnaire measures patients' psychological distress.

  2. Change from Baseline 'Caregiver Self-Assessment' at T2, T3 and T4. [ Time Frame: 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. ]
    This 18-item questionnaire measures family caregivers' well-being.

  3. Change from Baseline 'Cancer Coherence Scale' at T2, T3 and T4. [ Time Frame: 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. ]
    This 11-item questionnaire measures patients' and family caregivers' perceived meaning in life.

  4. Change from Baseline 'World Health Organization Quality of Life Scale-8' at T2, T3 and T4. [ Time Frame: 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. ]
    This 11-item questionnaire measures patients' and family caregivers' perceived quality of life.

  5. Change from Baseline 'FACIT Spiritual Well-being Scale' at T2, T3 and T4. [ Time Frame: 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. ]
    This 12-item questionnaire measures patients' and family caregivers' spirituality.

  6. Change from Baseline 'Herth Hope Index' at T2, T3 and T4. [ Time Frame: 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. ]
    This 12-item questionnaire measures patients' and family caregivers' hopefulness.

  7. Change from Baseline 'Inventory of Social Support' at T2 and T3, as well as T4 for caregivers only. [ Time Frame: 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. ]
    This 5-item questionnaire measures patients' and family caregivers' perceived social support.

  8. Brief Grief Questionnaire [ Time Frame: This will serve as a secondary outcome for family caregivers only, This will be assessed two months [T4] following family caregivers' bereavement. ]
    This 5-item questionnaire measures family caregivers' experience with grief.

  9. Core Bereavement Items [ Time Frame: This will serve as a secondary outcome for family caregivers only, This will be assessed two months [T4] following family caregivers' bereavement. ]
    This 17-item questionnaire measures family caregivers' experience with bereavement.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200730


Contacts
Contact: Andy Ho, PhD, EdD +65 63168943 andyhyho@ntu.edu.sg
Contact: Geraldine Tan-Ho, Msoc.Sc +6565923677 geraldinetan@ntu.edu.sg

Locations
Singapore
Dover Park Hospice Care Recruiting
Singapore, Singapore, 308436
Contact: Wah Ying Ong, MBBS    +65 65007272    wahying@doverpark.sg   
HCA Hospice Care Recruiting
Singapore, Singapore, 308437
Contact: Poh Heng Chong, MBBS    +65 62512561    pohhengC@hcahospicecare.org.sg   
Sponsors and Collaborators
Nanyang Technological University
HCA Hospice Care Singapore
Dover Park Hospice Singapore
National Cancer Centre, Singapore
University of Manitoba
University of Memphis
Investigators
Principal Investigator: Andy Ho, PhD, EdD Nanyang Technological University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andy Hau Yan Ho, PhD, EdD, Assistant Professor, Nanyang Technological University
ClinicalTrials.gov Identifier: NCT03200730     History of Changes
Other Study ID Numbers: IRB-2017-02-019
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andy Hau Yan Ho, PhD, EdD, Nanyang Technological University:
Family Dignity Intervention
Multicentre Randomized Control Trial
Palliative Care
End-of-Life Care