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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Chang Gung University
Sponsor:
Information provided by (Responsible Party):
Siew Tzuh Tang, Chang Gung University
ClinicalTrials.gov Identifier:
NCT01912846
First received: July 18, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
End Stage Cancer
Behavioral: Interactive advance care planning
Behavioral: Attention usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: An Interactive Advance Care Planning Intervention to Facilitate a Good Death for Cancer Patients

Resource links provided by NLM:


Further study details as provided by Chang Gung University:

Primary Outcome Measures:
  • Congruence between preferred and actual EOL care received [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.

  • Quality of life for terminally ill cancer patients [ Time Frame: 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. ] [ Designated as safety issue: No ]
    McGill Quality of Life Questionnaire will be used to measure quality of life.

  • Psychological well-beings for terminally ill cancer patients [ Time Frame: 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. ] [ Designated as safety issue: No ]

    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.


  • Family depressive symptoms [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Depressive symptoms will be measured by the Center for Epidemiological Studies-Depression Scale.

  • Family quality of life [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Quality of life for family caregivers while they provide end-of-life care will be measured by the Caregiver Quality of Life Index-Cancer.

  • Bereavement adjustment-Family depressive symptoms [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Center for Epidemiological Studies-Depression Scale will be used to measure depressive symptom for bereaved family caregivers.

  • Bereavement adjustment-complicated grief [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Complicated grief experience by family caregivers during their bereavement will be measured by the Inventory of Complicated Grief.


Secondary Outcome Measures:
  • Patient prognosis awareness [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Terminally ill cancer patients' understanding whether their disease will be cured or not be cured and probability to die in the near future.

  • Family prognosis awareness [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Family caregivers' understanding whether their relative's disease can be cured or not be cured and probability will die in the near future.

  • EOL care discussions among patients, families, and physicians [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Discussions about the preferences for end-of-life care and advanced care planning.

  • The extent of patient-family agreement on the preferences of EOL care [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.

  • Aggressive EOL care treatments [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 462
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Attention usual care intervention

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
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..
Experimental: Interactive advance care planning
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

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.

Other Name: Interactive ACP

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Terminally ill cancer patients are they:

  1. 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
  2. are cognitively competent
  3. can communicate with data collectors
  4. age ≧ 20
  5. have a designated family caregiver who agrees to participate in the survey.

Family caregivers will be recruited if they are:

  1. family members of cancer patients with a terminally ill disease as defined by this proposed study
  2. identified by the patients as the persons primarily conduct the patient's care needs without receiving financial reimbursement for the care they provide
  3. age≧20
  4. who agree to participate and can communicate with data collectors.

Exclusion Criteria:

  1. Patients or family caregivers who are not able to communicate coherently.
  2. Only one party in the patient-family dyad agrees to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912846

Contacts
Contact: Siew Tzuh Tang, DNSc 011-886-922-347-122 sttang@mail.cgu.edu.tw

Locations
Taiwan
Chang Gung Memorial Hospital-LinKo Recruiting
Tao-Yuan, Taiwan, 333
Contact: Siew Tzuh Tang, DNSc    011-88922-347-122    sttang@mail.cgu.edu.tw   
Principal Investigator: Siew Tzuh Tang, DNSc         
Sub-Investigator: Jen-Shi Chen, MD         
Sub-Investigator: Wen-Chi Chou, MD         
Sponsors and Collaborators
Chang Gung University
Investigators
Principal Investigator: Siew Tzuh Tang, DNSc School of Nursing, Chang Gung University
  More Information

Publications:
Responsible Party: Siew Tzuh Tang, Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT01912846     History of Changes
Other Study ID Numbers: HMRPD1C0011, NHRI-EX102-10208PI
Study First Received: July 18, 2013
Last Updated: July 30, 2013
Health Authority: Taiwan: National Health Research Institutes
Taiwan: Department of Health

Keywords provided by Chang Gung University:
End-of-life care
Preference of end-of-life care
RCT
Terminally ill cancer patients

ClinicalTrials.gov processed this record on October 23, 2014