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

Lung Cancer Clinical Trial

Official title:

The Study of the Knowledge, Attitudes, and Decision Making Towards Clinical Trials in Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01341210
• Other study ID #: 201101071RC
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2011
• Last updated: August 23, 2013
• Start date: February 2011
• Est. completion date: February 2014

Study information

• Verified date: August 2013
• Source: National Taiwan University Hospital
• Contact: Ming-Tzu Wu, Master
• Phone: +886-926257263
• Email: r98426005[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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' 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Liver Cancer
• Lung Cancer

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	in 24 months	No
Secondary	The knowledge towards clinical trials in cancer patients		24 months	No
Secondary	The attitudes towards clinical trials in cancer patients		in 24 months	No
Secondary	The shared decision making level towards clinical trials in cancer patients		24 months	No
Secondary	The subjective norm and behavior intentions towards clinical trials in cancer patients		24 months	No