An Interactive Advance Care Planning Intervention to Facilitate a Good Death for Cancer Patients

NCT01912846 | Completed

• 2 other identifiers: HMRPD1C0011NHRI-EX102-10208PI
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Cancer

Keywords

End-of-life care; Preference of end-of-life care; RCT; Terminally ill cancer patients

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (5)

• Patient prognosis awareness

  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.

• Family prognosis awareness

  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.

• EOL care discussions among patients, families, and physicians

  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.

• The extent of patient-family agreement on the preferences of EOL 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.

• Aggressive EOL care treatments

  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.

Study Arms (2)

Attention usual care intervention

SHAM COMPARATOR

Interventions includes prognosis disclosure and discussions of EOL care as needed as in current clinical practices. Interventions of the attention usual care arm include a consistent master prepared nurse on the study team will provide the attention portion of the care and a workbook and a video with educational materials. 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.

Behavioral: Attention usual care

Interactive advance care planning

EXPERIMENTAL

The intervention aims at facilitating patients, families, and primary physicians to discuss the patient's wishes for EOL care by clarifying a terminally ill cancer patient's understanding of his/her prognosis and treatment options and her/his readiness for engagement in ACP, appropriately weighting the benefits and burdens of medical treatments at EOL, and clearly defining and documenting the patient's preferences so as to be readily available later for the patient's primary physician to guide EOL care decision-making which will honor the patient's preferences for EOL care.

Behavioral: Interactive advance care planning

Interventions

Interactive advance care planning BEHAVIORAL

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.

Also known as: Interactive ACP

Interactive advance care planning

Attention usual care BEHAVIORAL

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..

Attention usual care intervention

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Terminally ill cancer patients are they:
• have a disease at a terminal stage which continues to progress with distant metastases and is unresponsive to current curative cancer treatment as judged by their oncologists
• are cognitively competent
• can communicate with data collectors
• age ≧ 20
• have a designated family caregiver who agrees to participate in the survey.
• Family caregivers will be recruited if they are:
• family members of cancer patients with a terminally ill disease as defined by this proposed study
• identified by the patients as the persons primarily conduct the patient's care needs without receiving financial reimbursement for the care they provide
• age≧20
• who agree to participate and can communicate with data collectors.

You may not qualify if:

• Patients or family caregivers who are not able to communicate coherently.
• Only one party in the patient-family dyad agrees to participate.

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung Memorial Hospital-LinKo

Linkou District, 333, Taiwan

Location

Related Publications (10)

• 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. doi: 10.1016/j.jpainsymman.2005.05.019.

  PMID: 16376737 BACKGROUND

• 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. doi: 10.1016/j.socscimed.2005.02.006. Epub 2005 Apr 7.

  PMID: 16005787 BACKGROUND

• 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.

  PMID: 18521969 BACKGROUND

• 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.

  PMID: 18765460 BACKGROUND

• 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.

  PMID: 19704067 BACKGROUND

• Chen CH, Wen FH, Chang WC, Hsieh CH, Chou WC, Chen JS, Tang ST. Associations of prognostic-awareness-transition patterns with emotional distress and quality of life during terminally ill cancer patients' last 6 months of life. Psychooncology. 2023 May;32(5):741-750. doi: 10.1002/pon.6119. Epub 2023 Mar 14.

  PMID: 36891618 DERIVED

• Chen CH, Wen FH, Chou WC, Chen JS, Chang WC, Hsieh CH, Tang ST. Associations of prognostic-awareness-transition patterns with end-of-life care in cancer patients' last month. Support Care Cancer. 2022 Jul;30(7):5975-5989. doi: 10.1007/s00520-022-07007-4. Epub 2022 Apr 8.

  PMID: 35391576 DERIVED

• Wen FH, Chen CH, Chou WC, Chen JS, Chang WC, Hsieh CH, Tang ST. Evaluating if an Advance Care Planning Intervention Promotes Do-Not-Resuscitate Orders by Facilitating Accurate Prognostic Awareness. J Natl Compr Canc Netw. 2020 Dec 2;18(12):1658-1666. doi: 10.6004/jnccn.2020.7601. Print 2020 Dec.

  PMID: 33285517 DERIVED

• Wen FH, Chen JS, Chou WC, Chang WC, Hsieh CH, Tang ST. Extent and Determinants of Terminally Ill Cancer Patients' Concordance Between Preferred and Received Life-Sustaining Treatment States: An Advance Care Planning Randomized Trial in Taiwan. J Pain Symptom Manage. 2019 Jul;58(1):1-10.e10. doi: 10.1016/j.jpainsymman.2019.04.010. Epub 2019 Apr 18.

  PMID: 31004770 DERIVED

• Chen CH, Chen JS, Wen FH, Chang WC, Chou WC, Hsieh CH, Hou MM, Tang ST. An Individualized, Interactive Intervention Promotes Terminally Ill Cancer Patients' Prognostic Awareness and Reduces Cardiopulmonary Resuscitation Received in the Last Month of Life: Secondary Analysis of a Randomized Clinical Trial. J Pain Symptom Manage. 2019 Apr;57(4):705-714.e7. doi: 10.1016/j.jpainsymman.2019.01.002. Epub 2019 Jan 10.

  PMID: 30639758 DERIVED

Study Officials

• Siew Tzuh Tang, DNSc

  School of Nursing, Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 31, 2013
• Study Start: January 1, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-03

Locations

TW (1)