Lung CancerNCT01341210
Observational Study of the Decision Making Towards Clinical Trials in Cancer Patients
An observational study of Lung Cancer and Liver Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a cross-sectional, observational and correlational survey study.This study is aim to survey the the knowledge, attitudes, and decision making towards clinical trials in cancer patients in Taiwan (R.O.C.), which attempts to invite some cancer patients who have been experienced the treatment clinical trials'… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Lung Cancer, Liver Cancer
- How many people
- 116 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Feb 2014
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, cancer patients who have experience in contact with clinical trials
Who may be able to join
- Cancer patients who have been approved lung cancer or liver cancer.
- Patients who have been experienced the Informed consent process about clinical trial, which duration is in 6 months before they enter this study.
Who cannot join
- Patients who have conscious disorientation that can not answer questionnaire
- Patients only participate in some Gene clinical trials without treatment or drugs.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Wen-Yu Hu, PHD, +886-2-23123456 ext. 63160, ntuhrec@ntuh.gov.tw
Wen-Yu Hu, PHD
About this study
Official title: The Study of the Knowledge, Attitudes, and Decision Making Towards Clinical Trials in Cancer Patients
This is a cross-sectional, observational and correlational survey study.This study is aim to survey the the knowledge, attitudes, and decision making towards clinical trials in cancer patients in Taiwan (R.O.C.), which attempts to invite some cancer patients who have been experienced the treatment clinical trials' informed consent process. The research tool is a questionnaire which includes some scale: (1)Clinical trial Knowledge scale, (2) Attitude toward randomized clinical trials scale, (3) Shared Decision Making(SDM-Q-9),(4) Satisfaction with Decision (SWD-scale), and (5) Decision Regret scale(DRS). The investigators expect the research outcome can provide some instructions to improve patients' autonomy, satisfaction of the decision making and communication process between patients and Medical professors whenever cancer patients participating in clinical trials.
Read the detailed description
This study is been conduct in National Taiwan University Hospital , Taiwan. The main measurement tool is a self-report questionnaire, which is designed to answer some outcome measures for the following aspect:
- To find out the knowledge, attitudes, shared decision making level, subjective norm, and behavior intentions towards clinical trials in cancer patients.
- To find out the main influencing factors of behavior intentions towards participating in clinical trials
- Conditions
- Lung Cancer, Liver Cancer
- Keywords
- Patients Satisfaction, Decision Making, Informed Consent
- Medical subject headings
- Lung Neoplasms, Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The influencing factors of behavior intentions towards participating in clinical trials
The influencing factors was defined as following measurement scale:
- Knowledge
- Attitude
- decision making process
- sex
- age
- education
Measured: in 24 months
Secondary outcomes (4)
The knowledge towards clinical trials in cancer patients
Measured: 24 months
The attitudes towards clinical trials in cancer patients
Measured: in 24 months
The shared decision making level towards clinical trials in cancer patients
Measured: 24 months
The subjective norm and behavior intentions towards clinical trials in cancer patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Wen-Yu Hu, PHD, Principal investigator, National Taiwan University, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341210
- Sponsor's protocol ID
- 201101071RC
- Status last verified
- Aug 2013
- First submitted
- 21 Apr 2011
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of the Knowledge, Attitudes, and Decision Making Towards Clinical Trials in Cancer Patients
- ClinicalTrials.gov ID
- NCT01341210
- Acronym / sponsor ID
- 201101071RC
- Conditions
- Lung Cancer, Liver Cancer
- Keywords
- Patients Satisfaction, Decision Making, Informed Consent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 25 Apr 2011 (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.
This is a cross-sectional, observational and correlational survey study.This study is aim to survey the the knowledge, attitudes, and decision making towards clinical trials in cancer patients in Taiwan (R.O.C.), which attempts to invite some cancer patients who have been experienced the treatment clinical trials' informed consent process. The research tool is a questionnaire which includes some scale: (1)Clinical trial Knowledge scale, (2) Attitude toward randomized clinical trials scale, (3) Shared Decision Making(SDM-Q-9),(4) Satisfaction with Decision (SWD-scale), and (5) Decision Regret scale(DRS). The investigators expect the research outcome can provide some instructions to improve patients' autonomy, satisfaction of the decision making and communication process between patients and Medical professors whenever cancer patients participating in clinical trials.
Detailed description
This study is been conduct in National Taiwan University Hospital , Taiwan. The main measurement tool is a self-report questionnaire, which is designed to answer some outcome measures for the following aspect:
- To find out the knowledge, attitudes, shared decision making level, subjective norm, and behavior intentions towards clinical trials in cancer patients.
- To find out the main influencing factors of behavior intentions towards participating in clinical trials
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, cancer patients who have experience in contact with clinical trials
Key inclusion criteria (2 listed)
- Cancer patients who have been approved lung cancer or liver cancer.
- Patients who have been experienced the Informed consent process about clinical trial, which duration is in 6 months before they enter this study.
Key exclusion criteria (2 listed)
- Patients who have conscious disorientation that can not answer questionnaire
- Patients only participate in some Gene clinical trials without treatment or drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The influencing factors of behavior intentions towards participating in clinical trials
Time frame: in 24 months
The influencing factors was defined as following measurement scale: 1. Knowledge 2. Attitude 3. decision making process 4. sex 5. age 6. education
4 secondary outcomes
The knowledge towards clinical trials in cancer patients
Time frame: 24 months
The attitudes towards clinical trials in cancer patients
Time frame: in 24 months
The shared decision making level towards clinical trials in cancer patients
Time frame: 24 months
The subjective norm and behavior intentions towards clinical trials in cancer patients
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
Wen-Yu Hu, PHD principal investigator
National Taiwan University, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Liver Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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 26 Aug 2013. 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 Taiwan. 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 Ming-Tzu Wu, Master (+886-926257263, r98426005@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influencing factors of behavior intentions towards participating in clinical trials (time frame: in 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2013.