Effectiveness of Knowledge by Video and Handbook of Liver... | NCT02768428

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

NCT02768428

Sponsor

Chulabhorn Hospital

Status

Unknown status

Last Update Posted

May 11, 2016Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Cancer

Interventions

Video-Audio Media

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Apr 18, 2016

First Submission Date that Met QC Criteria

May 10, 2016

First Posted Date

May 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ruechuta Molek, Registered Nurse, Chulabhorn HospitalPrincipal Investigator

Lead Sponsor

Chulabhorn HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Video-Audio Media	Experimental	watching the entire video in 15 mins	Other: Video-Audio Media
Handbooks	No Intervention	study the hand book in 15 mins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video-Audio Media	Other	each arm spends 15 mins for watching the video or study the handbooks	Video-Audio Media

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ruechuta Molek, MNS	Contact	+66818661516		ruechuta.molek@gmail.com
Chaivej Nuchprayoon, Prof.	Contact	+6625766840		chaivej@hotmail.com

Overall Officials

Name	Affiliation	Role
Ruechuta Molek, MNS	Chulabhorn Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chulabhorn Hospital	Recruiting	Thailand	Bangkok	10210	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18477802	Background	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.
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