CancerNCT02768428
Effectiveness of Knowledge by Video and Handbook of Liver Cancer Patients With First Trans-arterial Chemoembolization
A study testing Video-Audio Media in people with Cancer, run by Chulabhorn Hospital at 1 site in Thailand.
Trial summary
Objective: To compare the effectiveness between Video and Handbook on providing knowledge of TACE. Study Design: A prospective, randomized, controlled trial. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Video-Audio Media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have psychological/mental problems
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chulabhorn Hospital
Thailand, Bangkok, 10210
Ruechuta Molek, MNS, +66818661516, ruechuta.molek@gmail.com
Chaivej Nuchprayoon, Prof., +6625766840, chaivej@hotmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- Cancer
- Being tested
- Video-Audio Media
- Keywords
- Knowledge [K01.468], Video-Audio Media [V01.255.500], Handbooks [V02.520]
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Audio MediaOther
Also called Handbooks
each arm spends 15 mins for watching the video or study the handbooks
| Study group | Role | What they receive |
|---|---|---|
| Video-Audio Media | Experimental | watching the entire video in 15 mins Receives: Other: Video-Audio Media |
| Handbooks | No intervention | study the hand book in 15 mins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulabhorn Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruechuta Molek, Chulabhorn Hospital
- Investigators
- Ruechuta Molek, MNS, Principal investigator, Chulabhorn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768428
- Sponsor's protocol ID
- 017/2015
- Status last verified
- May 2016
- First submitted
- 18 Apr 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 18477802Varela 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.
PubMed 17239480McCurdy 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.
PubMed 23549214Peduzzi 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.
PubMed 8970487Soerjomataram 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.
PubMed 23079588
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Knowledge by Video and Handbook to Measure Knowledge of Liver Cancer Patients With First Trans-arterial Chemoembolization (TACE)
- ClinicalTrials.gov ID
- NCT02768428
- Acronym / sponsor ID
- 017/2015
- Conditions
- Cancer
- Keywords
- Knowledge [K01.468], Video-Audio Media [V01.255.500], Handbooks [V02.520]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chulabhorn HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-Audio Media | Experimental | Other: Video-Audio Mediawatching the entire video in 15 mins |
| Handbooks | No intervention | –study the hand book in 15 mins |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 20 - 75 years
- Willing to participate the study
- 1st TACE
- Can comprehend all information in video or handbook
- No trouble of hearing
Key exclusion criteria (1 listed)
- Have psychological/mental problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Audio MediaAlso: Handbookseach arm spends 15 mins for watching the video or study the handbooks | Other | Video-Audio Media |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Background: PubMed 18477802Llovet 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.
- Background: PubMed 17239480Varela 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.
- Background: PubMed 23549214McCurdy 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.
- Background: PubMed 8970487Peduzzi 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 publication: PubMed 23079588Soerjomataram 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruechuta Molek, MNS principal investigator
Chulabhorn Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Audio Media in people with Cancer, run by Chulabhorn Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruechuta Molek, MNS (+66818661516, ruechuta.molek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge about TACE (A 40-item exam is performed to test the patients' knowledge) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02768428, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.