A Multicenter Randomized Controlled Trial of a Novel Family Dignity Intervention (FDI) for Asian Palliative Care
试验速览
- 阶段
- 不适用
- 入组人数
- 252
- 试验地点
- 4
- 主要终点
- Change from Baseline 'Patient Health Questionnaire' at 14 days [T2] and 4 week [T3] follow-up, and 2 months [T4] post bereavement.
研究概览
简要总结
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.
详细描述
Study Design
This study adopts an open-label multicentre randomized controlled trial design comprising of two groups: (i) intervention group (Family Dignity Intervention offered in addition to standard psychological care), and (ii) control group (standard psychological care include emotional support and psychosocial home visits). Consenting participants including one patient and one family caregiver from one family unit (i.e. patient-family dyad) will be randomly allocated to one of these two groups after baseline assessment meetings have been conducted.
Study Sites
Study settings include two hospice service providers in Singapore. First, Dover Park Hospice (DPH) is a secular, nonprofit organization that offers both in-patient and homecare hospice services to terminally-ill patients and their families. It is one of the largest hospice service provider in the country with over 50 in-patient beds. Second, HCA Hospice Care (HCA) is a registered charity that offers daycare and homecare hospice services to terminally-ill patients and their families. With a head office and numerous satellite service stations across the country, it offers national wide services to all Singaporeans. Both DPH and HCA are funded publically and via donations, service admission are based on physician referrals and mean-testing mechanisms as ascribed by the Singapore Ministry of Health. Both service providers house a team of palliative care specialist including physicians, nurses, social workers and counselors to provide round-the-clock support to individuals and families facing the end of life.
Participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Family Dignity Intervention group (Behavioral)
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.
结局指标
主要结局
Change from Baseline 'Patient Health Questionnaire' at 14 days [T2] and 4 week [T3] follow-up, and 2 months [T4] post bereavement.
时间窗: 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.
Change from Baseline 'Patient Dignity Inventory (PDI)' at 14 days [T2] and 4 weeks [T3] follow-up.
时间窗: 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.
次要结局
- 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 'Inventory of Social Support' at T2 and T3, as well as T4 for caregivers only.(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.)
- Brief Grief Questionnaire(This will serve as a secondary outcome for family caregivers only, This will be assessed two months [T4] following family caregivers' bereavement.)
- Change from Baseline 'Herth Hope Index' 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.)
- Core Bereavement Items(This will serve as a secondary outcome for family caregivers only, This will be assessed two months [T4] following family caregivers' 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.)
研究者
Andy Hau Yan Ho, PhD, EdD
Assistant Professor
Nanyang Technological University