Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness
This study is not yet open for participant recruitment.
Verified by National Cancer Center, Korea, May 2008
Sponsored by: National Cancer Center, Korea
Information provided by: National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00686673
  Purpose

This study is randomized controlled trial that will compare two arms: an experimental intervention group that receives a decision aid consisting of an educational video and targeted manual providing a protocol for the family members' disclosing terminal illness to the patients and aimed at improving communication, satisfaction with decision making process, and quality of life between patients and their family versus an attention control group that receives a video and non-tailored manual on pain control.


Condition Intervention
Terminal Illness
 Behavioral: Providing tailored message on disclosing terminal illness
Behavioral: Providing non-tailored message on pain control

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness to Patient With Terminal Cancer

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Decisional conflict & satisfaction: Decisional Conflict Scale [ Time Frame: baseline, 1month, 3month, 6month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life: Quality Care Questionnaire-End of Life(QCQ-EOL), Korean version of the Caregiver Quality of Life Index - Cancer(CQOLC-K) [ Time Frame: baseline, 1month, 3month, 6month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 440
Study Start Date: June 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Providing Videotape-based material & tailored workbook to make informed choice of disclosing terminal illness to patients
Behavioral: Providing tailored message on disclosing terminal illness
an experimental intervention group that receives a decision aid consisting of targeted educational video and manual providing a protocol for disclosing terminal illness and aimed at improving communication between patients and their family
B

Attention control arm:

Providing videotape-based material & non-tailored workbook about pain control

 Behavioral: Providing non-tailored message on pain control
an attention control group that receives non-tailored video and manual on pain control

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient:

  • age≥ 18years
  • cancer patient
  • terminally ill
  • mentally competent

Family members:

  • age≥ 18years
  • having terminally ill cancer patients
  • Spouse, daughter or son, parent, brother or sister
  • having ability to understand the content of educational material

Exclusion Criteria:

  • serious comorbidity(stroke, heart attack, acute or chronic respiratory, acute or chronic renal disease, or cancer)
  • inability to speak, hear or read Korean
  • mentally incompetence (schizophrenia, bipolar, psychiatric or addictive disorder, or severe emotional distress)
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686673

Contacts
Contact: Young Ho Yun, MD, PhD 82-31-920-1507 ext 1507 lawyun08@ncc.re.kr
Contact: Myung Kyung Lee, MPH 82-31-920-2192 ext 2192 mlee005@empal.com

Locations
Korea, Republic of, Gyeonggi-do
National Cancer Center
809 Madu-dong, Ilsan-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Young Ho Yun, MD, PhD National Cancer Center, Korea
  More Information

Responsible Party: National Cancer Center, Korea ( Division of cancer control )
Study ID Numbers: nccncs-08-142
Study First Received: May 28, 2008
Last Updated: May 29, 2008
ClinicalTrials.gov Identifier: NCT00686673  
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
DECISION AIDS

ClinicalTrials.gov processed this record on January 16, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services