Effectiveness of Knowledge by Video and Handbook of Liver Cancer Patients With First Trans-arterial Chemoembolization
Primary Purpose
Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Video-Audio Media
Sponsored by
About this trial
This is an interventional health services research trial for Cancer focused on measuring Knowledge [K01.468], Video-Audio Media [V01.255.500], Handbooks [V02.520]
Eligibility Criteria
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
Sites / Locations
- Chulabhorn HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Video-Audio Media
Handbooks
Arm Description
watching the entire video in 15 mins
study the hand book in 15 mins
Outcomes
Primary Outcome Measures
knowledge about TACE (A 40-item exam is performed to test the patients' knowledge)
The points of interest are the effectiveness of medias on learning achievement and relative growth of knowledge.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02768428
Brief Title
Effectiveness of Knowledge by Video and Handbook of Liver Cancer Patients With First Trans-arterial Chemoembolization
Official Title
Effectiveness of Knowledge by Video and Handbook to Measure Knowledge of Liver Cancer Patients With First Trans-arterial Chemoembolization (TACE)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulabhorn Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objective: To compare the effectiveness between Video and Handbook on providing knowledge of TACE.
Study Design: A prospective, randomized, controlled trial.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Knowledge [K01.468], Video-Audio Media [V01.255.500], Handbooks [V02.520]
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video-Audio Media
Arm Type
Experimental
Arm Description
watching the entire video in 15 mins
Arm Title
Handbooks
Arm Type
No Intervention
Arm Description
study the hand book in 15 mins
Intervention Type
Other
Intervention Name(s)
Video-Audio Media
Other Intervention Name(s)
Handbooks
Intervention Description
each arm spends 15 mins for watching the video or study the handbooks
Primary Outcome Measure Information:
Title
knowledge about TACE (A 40-item exam is performed to test the patients' knowledge)
Description
The points of interest are the effectiveness of medias on learning achievement and relative growth of knowledge.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruechuta Molek, MNS
Phone
+66818661516
Email
ruechuta.molek@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chaivej Nuchprayoon, Prof.
Phone
+6625766840
Email
chaivej@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruechuta Molek, MNS
Organizational Affiliation
Chulabhorn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulabhorn Hospital
City
Thailand
State/Province
Bangkok
ZIP/Postal Code
10210
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruechuta Molek, MNS
Phone
+66818661516
Email
ruechuta.molek@gmail.com
First Name & Middle Initial & Last Name & Degree
Chaivej Nuchprayoon, Prof.
Phone
+6625766840
Email
chaivej@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
18477802
Citation
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.
Results Reference
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PubMed Identifier
17239480
Citation
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.
Results Reference
background
PubMed Identifier
23549214
Citation
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.
Results Reference
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PubMed Identifier
8970487
Citation
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.
Results Reference
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PubMed Identifier
23079588
Citation
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.
Results Reference
result
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Effectiveness of Knowledge by Video and Handbook of Liver Cancer Patients With First Trans-arterial Chemoembolization
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