NCT00686673

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 15, 2011

Status Verified

March 1, 2009

Enrollment Period

Same day

First QC Date

May 28, 2008

Last Update Submit

February 14, 2011

Conditions

Terminal Illness

Keywords

DECISION AIDS

Outcome Measures

Primary Outcomes (1)

  • Decisional conflict & satisfaction: Decisional Conflict Scale

    baseline, 1month, 3month, 6month

Secondary Outcomes (1)

  • Quality of Life: Quality Care Questionnaire-End of Life(QCQ-EOL), Korean version of the Caregiver Quality of Life Index - Cancer(CQOLC-K)

    baseline, 1month, 3month, 6month

Study Arms (2)

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

B

OTHER

Attention control arm: Providing videotape-based material \& non-tailored workbook about pain control

Behavioral: Providing non-tailored message on pain control

Interventions

Providing tailored message on disclosing terminal illnessBEHAVIORAL

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

A
Providing non-tailored message on pain controlBEHAVIORAL

an attention control group that receives non-tailored video and manual on pain control

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

National Cancer Center

809 Madu-dong, Ilsan-gu, Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Kyung Hee University Medical Center

Seoul, Seoul, 130-702, South Korea

Location

The Catholic University of Korea Kangnam St. Mary's Hospital

Seoul, Seoul, 137-701, South Korea

Location

Bobath Memorial Hospital

Bundang-gu, Seongnam-si,Gyeonggi-do, 463-805, South Korea

Location

Gyeongsang National University Hospital

Chiram-dong, Jinju-si, Gyeongsangnam-do, 660-702, South Korea

Location

The Catholic University of Korea, Daejeon St. Mary's Hospital

Daeheung-dong, Jung-gu, Daejeon, 301-804, South Korea

Location

Daegu Fatima Hospital

Dong-gu, Daegu, 701-600, South Korea

Location

Korea University Guro Hospital

Guro-gu, Seoul,, 152-703, South Korea

Location

Keimyung University Dongsan Medical Center

Jung-gu, Daegu,, 700-712, South Korea

Location

Chungnam National University Hospital

Jung-gu,Daejeon, 301-721, South Korea

Location

Kwangju Christian Hospital

Kwangju, 503-715, South Korea

Location

Sunlin Hospital Handong University

Pohang, 791-704, South Korea

Location

Gangneung Asan Hospital

Sacheon-myeon, Gangneung-si, Gangwon-do, 210-711, South Korea

Location

Study Officials

  • Young Ho Yun, MD, PhD

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 28, 2008

First Posted

May 30, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2008

Study Completion

March 1, 2009

Last Updated

February 15, 2011

Record last verified: 2009-03

Locations

KR(14)