Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness
This study has been completed.
Sponsor:
National Cancer Center, Korea
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
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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 |
Resource links provided by NLM:
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
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 | |
| Kyung Hee University Medical Center | |
| Seoul, Korea, Republic of, 130-702 | |
| The Catholic University of Korea Kangnam St. Mary's Hospital | |
| Seoul, Korea, Republic of, 137-701 | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
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 May 23, 2013