- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02768428
Effectiveness of Knowledge by Video and Handbook of Liver Cancer Patients With First Trans-arterial Chemoembolization
Effectiveness of Knowledge by Video and Handbook to Measure Knowledge of Liver Cancer Patients With First Trans-arterial Chemoembolization (TACE)
Objective: To compare the effectiveness between Video and Handbook on providing knowledge of TACE.
Study Design: A prospective, randomized, controlled trial.
Study Overview
Detailed Description
Background : Liver cancer is a serious disease with a high death rate. One of the treatment modalities for liver cancer is TACE. Patients always scare of the first TACE due to their lack of knowledge and inadequate comprehension of the procedure. Hence, they crave to have a good quality in nursing service. Researcher would like to compare the effectiveness knowledge between Video and Handbook regarding patients' health education.
Objective: To compare the effectiveness between Video and Handbook on providing knowledge of TACE.
Study Design: A prospective, randomized, controlled trial.
Setting: Chulabhorn Hospital, Bangkok, THAILAND.
Methods : Eighty liver cancer patients are included in the study. They are systematically computerized and randomized into two groups - an experiment or video group (N 40) and a control or Handbook group (N = 40). A 40-item exam is performed to test the patients' knowledge before (x score), after (y score) and 60 days (z score) after the procedure. The 15-min study was taken in an isolated room. The points of interest are the effectiveness of medias on learning achievement and relative growth of knowledge. The relative growth of knowledge (G1, G2 score) was calculated as follows:
G1 = 100 (Y-X)/(F-X) % ; G2 = 100 (Z-X)/(F-X)%
Retention of knowledge (R) = 100 - (G1 - G2) %
Where G = Relative growth of knowledge R = Retention of knowledge X = Pre-test score Y = Post-test score Z = Final-test score F = Total score
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bangkok
-
Thailand, Bangkok, Thailand, 10210
- Recruiting
- Chulabhorn Hospital
-
Contact:
- Ruechuta Molek, MNS
- Phone Number: +66818661516
- Email: ruechuta.molek@gmail.com
-
Contact:
- Chaivej Nuchprayoon, Prof.
- Phone Number: +6625766840
- Email: chaivej@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 20 - 75 years
- Willing to participate the study
- 1st TACE
- Can comprehend all information in video or handbook
- No trouble of hearing
- Can complete the 40-item test
Exclusion Criteria:
- Have psychological/mental problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video-Audio Media
watching the entire video in 15 mins
|
each arm spends 15 mins for watching the video or study the handbooks
Other Names:
|
|
No Intervention: Handbooks
study the hand book in 15 mins
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
knowledge about TACE (A 40-item exam is performed to test the patients' knowledge)
Time Frame: 2 years
|
The points of interest are the effectiveness of medias on learning achievement and relative growth of knowledge.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ruechuta Molek, MNS, Chulabhorn Hospital
Publications and helpful links
General Publications
- Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. doi: 10.1016/s0895-4356(96)00236-3.
- Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.
- Varela M, Real MI, Burrel M, Forner A, Sala M, Brunet M, Ayuso C, Castells L, Montana X, Llovet JM, Bruix J. Chemoembolization of hepatocellular carcinoma with drug eluting beads: efficacy and doxorubicin pharmacokinetics. J Hepatol. 2007 Mar;46(3):474-81. doi: 10.1016/j.jhep.2006.10.020. Epub 2006 Nov 29.
- McCurdy HM. Improving outcomes for patients receiving transarterial chemoembolization for hepatocellular carcinoma. Gastroenterol Nurs. 2013 Mar-Apr;36(2):114-20. doi: 10.1097/SGA.0b013e318288c8be.
- Soerjomataram I, Lortet-Tieulent J, Parkin DM, Ferlay J, Mathers C, Forman D, Bray F. Global burden of cancer in 2008: a systematic analysis of disability-adjusted life-years in 12 world regions. Lancet. 2012 Nov 24;380(9856):1840-50. doi: 10.1016/S0140-6736(12)60919-2. Epub 2012 Oct 16.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 017/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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