Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness

This study has been completed.
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00686673
First received: May 28, 2008
Last updated: February 14, 2011
Last verified: March 2009
  Purpose

This study is a 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Completion Date: March 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
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: NCT00686673

Locations
Korea, Republic of
National Cancer Center
809 Madu-dong, Ilsan-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
Bobath Memorial Hospital
Bundang-gu, Seongnam-si,Gyeonggi-do, Korea, Republic of, 463-805
Gyeongsang National University Hospital
Chiram-dong, Jinju-si, Gyeongsangnam-do, Korea, Republic of, 660-702
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daeheung-dong, Jung-gu, Daejeon, Korea, Republic of, 301-804
Daegu Fatima Hospital
Dong-gu, Daegu, Korea, Republic of, 701-600
Korea University Guro Hospital
Guro-gu, Seoul,, Korea, Republic of, 152-703
Keimyung University Dongsan Medical Center
Jung-gu, Daegu,, Korea, Republic of, 700-712
Chungnam National University Hospital
Jung-gu,Daejeon, Korea, Republic of, 301-721
Kwangju Christian Hospital
Kwangju, Korea, Republic of, 503-715
Sunlin Hospital Handong University
Pohang, Korea, Republic of, 791-704
Gangneung Asan Hospital
Sacheon-myeon, Gangneung-si, Gangwon-do, Korea, Republic of, 210-711
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
The Catholic University of Korea Kangnam St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Kyung Hee University Medical Center
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Young Ho Yun, MD, PhD National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Division of cancer control, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00686673     History of Changes
Other Study ID Numbers: nccncs-08-142
Study First Received: May 28, 2008
Last Updated: February 14, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
DECISION AIDS

ClinicalTrials.gov processed this record on October 01, 2014