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Observational Study of the Decision Making Towards Clinical Trials in Cancer Patients

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ClinicalTrials.gov Identifier: NCT01341210
Recruitment Status : Unknown
Verified August 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : April 25, 2011
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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' 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.

Condition or disease
Lung Cancer Liver Cancer

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:

  1. To find out the knowledge, attitudes, shared decision making level, subjective norm, and behavior intentions towards clinical trials in cancer patients.
  2. To find out the main influencing factors of behavior intentions towards participating in clinical trials

Study Design

Study Type : Observational
Estimated Enrollment : 116 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Study of the Knowledge, Attitudes, and Decision Making Towards Clinical Trials in Cancer Patients
Study Start Date : February 2011
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The knowledge towards clinical trials in cancer patients [ Time Frame: 24 months ]
  2. The attitudes towards clinical trials in cancer patients [ Time Frame: in 24 months ]
  3. The shared decision making level towards clinical trials in cancer patients [ Time Frame: 24 months ]
  4. The subjective norm and behavior intentions towards clinical trials in cancer patients [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult, cancer patients who have experience in contact with clinical trials
Criteria

Inclusion Criteria:

  1. Cancer patients who have been approved lung cancer or liver cancer.
  2. Patients who have been experienced the Informed consent process about clinical trial, which duration is in 6 months before they enter this study.

Exclusion Criteria:

  1. Patients who have conscious disorientation that can not answer questionnaire
  2. Patients only participate in some Gene clinical trials without treatment or drugs.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341210


Contacts
Contact: Ming-Tzu Wu, Master +886-926257263 r98426005@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Wen-Yu Hu, PHD    +886-2-23123456 ext 63160    ntuhrec@ntuh.gov.tw   
Principal Investigator: Wen-Yu Hu, PHD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wen-Yu Hu, PHD National Taiwan University, Department of Nursing
More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01341210     History of Changes
Other Study ID Numbers: 201101071RC
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013

Keywords provided by National Taiwan University Hospital:
Patients Satisfaction
Decision Making
Informed Consent

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases