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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01912846
Other study ID # HMRPD1C0011
Secondary ID NHRI-EX102-10208
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2013
Est. completion date December 31, 2018

Study information

Verified date March 2019
Source Chang Gung University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this 5-year interventional study is to design, implement, and evaluate the effectiveness of an intervention aimed at facilitating prognosis communication and end-of-life care decision-making to increase the extent of congruence between the patient's preferred and actual EOL care received and patients' and family caregivers' QOL and psychological well-being, reduce futile aggressive healthcare resources utilization at end-of-life, and facilitate bereavement adjustment.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Interactive advance care planning
The facilitator will begin each course of intervention by assessing the patient's and his/her family caregiver's readiness for engagement in ACP independently. Providing participant-centered care tailored to the specific needs of participants at each stage of readiness for engagement in ACP. Facilitating EOL care discussions throughout the dying process. A workbook and a video decision aid that briefly describes ACP to enhance participants' understanding of the essential elements in ACP.
Attention usual care
a consistent master prepared nurse on the study team will provide the attention portion of the care. The initial meeting will occur before the patient discharges from hospital and the usual care nurse will give patients and family caregivers a workbook and a video with educational materials on how to manage common symptoms and a comprehensive list of resources available, including patient support organizations, support and financial assistance through the social work department..

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital-LinKo Linkou

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Tang ST, Liu TW, Lai MS, Liu LN, Chen CH. Concordance of preferences for end-of-life care between terminally ill cancer patients and their family caregivers in Taiwan. J Pain Symptom Manage. 2005 Dec;30(6):510-8. — View Citation

Tang ST, Liu TW, Lai MS, McCorkle R. Discrepancy in the preferences of place of death between terminally ill cancer patients and their primary family caregivers in Taiwan. Soc Sci Med. 2005 Oct;61(7):1560-6. Epub 2005 Apr 7. — View Citation

Tang ST, Liu TW, Tsai CM, Wang CH, Chang GC, Liu LN. Patient awareness of prognosis, patient-family caregiver congruence on the preferred place of death, and caregiving burden of families contribute to the quality of life for terminally ill cancer patients in Taiwan. Psychooncology. 2008 Dec;17(12):1202-9. doi: 10.1002/pon.1343. — View Citation

Tang ST, Wu SC, Hung YN, Chen JS, Huang EW, Liu TW. Determinants of aggressive end-of-life care for Taiwanese cancer decedents, 2001 to 2006. J Clin Oncol. 2009 Sep 20;27(27):4613-8. doi: 10.1200/JCO.2008.20.5096. Epub 2009 Aug 24. — View Citation

Tang ST, Wu SC, Hung YN, Huang EW, Chen JS, Liu TW. Trends in quality of end-of-life care for Taiwanese cancer patients who died in 2000-2006. Ann Oncol. 2009 Feb;20(2):343-8. doi: 10.1093/annonc/mdn602. Epub 2008 Sep 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Congruence between preferred and actual EOL care received EOL care includes (1) life-prolonging or comfort-oriented EOL care, (2) CPR when life is in danger, (3) life-sustaining treatments, including cardiac massage, mechanical ventilation, ICU care, tube feeding, intravenous nutrition, and hemodialysis, and (4) hospice care. An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Primary Quality of life for terminally ill cancer patients McGill Quality of Life Questionnaire will be used to measure quality of life. An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Primary Psychological well-beings for terminally ill cancer patients Depression and anxiety for terminally ill cancer patients.
Anxiety and depressive symptoms of terminally ill cancer patients will be measured by the Hospital Anxiety and Depression Scale.
An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Primary Family depressive symptoms Depressive symptoms will be measured by the Center for Epidemiological Studies-Depression Scale. An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Primary Family quality of life Quality of life for family caregivers while they provide end-of-life care will be measured by the Caregiver Quality of Life Index-Cancer. An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Primary Bereavement adjustment-Family depressive symptoms Center for Epidemiological Studies-Depression Scale will be used to measure depressive symptom for bereaved family caregivers. Bereavement interviews will be conducted 1, 3, 6 and 13 months after the time of death in order to avoid contamination on the basis of anniversary grief reactions.
Primary Bereavement adjustment-complicated grief Complicated grief experience by family caregivers during their bereavement will be measured by the Inventory of Complicated Grief. Bereavement interviews will be conducted 1, 3, 6 and 13 months after the time of death in order to avoid contamination on the basis of anniversary grief reactions.
Secondary Patient prognosis awareness Terminally ill cancer patients' understanding whether their disease will be cured or not be cured and probability to die in the near future. An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Secondary Family prognosis awareness Family caregivers' understanding whether their relative's disease can be cured or not be cured and probability will die in the near future. An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Secondary EOL care discussions among patients, families, and physicians Discussions about the preferences for end-of-life care and advanced care planning. An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Secondary The extent of patient-family agreement on the preferences of EOL care The extent of patient-family agreements on preferences of cardiopulmonary resuscitation when life is in danger, life-sustaining treatments, including cardiac massage, mechanical ventilation, ICU care, tube feeding, intravenous nutrition, and hemodialysis, and hospice care. An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Secondary Aggressive EOL care treatments Aggressive EOL care received by terminally ill cancer patients include cardiopulmonary resuscitation, life-sustaining treatments, including cardiac massage, mechanical ventilation, ICU care, tube feeding, intravenous nutrition, and hemodialysis, and hospice care. After each patient's death, a chart review and postmortem interview with patients' caregivers will be performed to confirm the type of medical care received at the EOL.
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