NCT02768428

Brief Summary

Objective: To compare the effectiveness between Video and Handbook on providing knowledge of TACE. Study Design: A prospective, randomized, controlled trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

April 18, 2016

Last Update Submit

May 10, 2016

Conditions

Cancer

Keywords

Knowledge [K01.468]Video-Audio Media [V01.255.500]Handbooks [V02.520]

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Video-Audio MediaOTHER

each arm spends 15 mins for watching the video or study the handbooks

Also known as: Handbooks
Video-Audio Media

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20 - 75 years
  • Willing to participate the study
  • st TACE
  • Can comprehend all information in video or handbook
  • No trouble of hearing
  • Can complete the 40-item test

You may not qualify if:

  • Have psychological/mental problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulabhorn Hospital

Thailand, Bangkok, 10210, Thailand

RECRUITING

Related 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.

    PMID: 18477802BACKGROUND

  • 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.

    PMID: 17239480BACKGROUND

  • 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.

    PMID: 23549214BACKGROUND

  • 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.

    PMID: 8970487BACKGROUND

  • 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.

    PMID: 23079588RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ruechuta Molek, MNS

    Chulabhorn Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruechuta Molek, MNS

CONTACT

+66818661516ruechuta.molek@gmail.com

Chaivej Nuchprayoon, Prof.

CONTACT

+6625766840chaivej@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

April 18, 2016

First Posted

May 11, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

May 11, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Locations

TH(1)