Effectiveness of Knowledge by Video and Handbook of Liver Cancer Patients With First Trans-arterial Chemoembolization

Cancer Clinical Trial

Official title:

Effectiveness of Knowledge by Video and Handbook to Measure Knowledge of Liver Cancer Patients With First Trans-arterial Chemoembolization (TACE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02768428
• Other study ID #: 017/2015
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2016
• Last updated: May 10, 2016
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: May 2016
• Source: Chulabhorn Hospital
• Contact: Ruechuta Molek, MNS
• Phone: +66818661516
• Email: ruechuta.molek[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Objective: To compare the effectiveness between Video and Handbook on providing knowledge of TACE.

Study Design: A prospective, randomized, controlled trial.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Video-Audio Media
each arm spends 15 mins for watching the video or study the handbooks

Locations

Country	Name	City	State
Thailand	Chulabhorn Hospital	Thailand	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulabhorn Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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/S0140-6 — View Citation

Varela M, Real MI, Burrel M, Forner A, Sala M, Brunet M, Ayuso C, Castells L, Montañá 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. Epub 2006 Nov 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	Yes