Observational Study of the Decision Making Towards Clinical Trials in Cancer Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by National Taiwan University Hospital.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
National Taiwan University Hospital
First received: April 21, 2011
Last updated: August 23, 2013
Last verified: August 2013
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.
||Observational Model: Case-Only
Time Perspective: Cross-Sectional
||The Study of the Knowledge, Attitudes, and Decision Making Towards Clinical Trials in Cancer Patients
Primary Outcome Measures:
- The influencing factors of behavior intentions towards participating in clinical trials [ Time Frame: in 24 months ] [ Designated as safety issue: No ]
The influencing factors was defined as following measurement scale:
- decision making process
Secondary Outcome Measures:
- The knowledge towards clinical trials in cancer patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- The attitudes towards clinical trials in cancer patients [ Time Frame: in 24 months ] [ Designated as safety issue: No ]
- The shared decision making level towards clinical trials in cancer patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- The subjective norm and behavior intentions towards clinical trials in cancer patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2014 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||20 Years to 90 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult, cancer patients who have experience in contact with clinical trials
- 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.
- Patients who have conscious disorientation that can not answer questionnaire
- Patients only participate in some Gene clinical trials without treatment or drugs.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341210
|National Taiwan University Hospital
|Taipei, Taiwan |
National Taiwan University Hospital
||Wen-Yu Hu, PHD
||National Taiwan University, Department of Nursing
||National Taiwan University Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 21, 2011
||August 23, 2013
||Taiwan: Department of Health
Keywords provided by National Taiwan University Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016
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