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

• Conditions: Lung Cancer; Liver Cancer

• Registration Number: NCT01341210
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-25
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The influencing factors of behavior intentions towards participating in clinical trials	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

Name	Time	Method
The knowledge towards clinical trials in cancer patients	24 months
The attitudes towards clinical trials in cancer patients	in 24 months
The shared decision making level towards clinical trials in cancer patients	24 months
The subjective norm and behavior intentions towards clinical trials in cancer patients	24 months

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan