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

August 23, 2013 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Wen-Yu Hu, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult, cancer patients who have experience in contact with clinical trials

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
in 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The knowledge towards clinical trials in cancer patients
Time Frame: 24 months
24 months
The attitudes towards clinical trials in cancer patients
Time Frame: in 24 months
in 24 months
The shared decision making level towards clinical trials in cancer patients
Time Frame: 24 months
24 months
The subjective norm and behavior intentions towards clinical trials in cancer patients
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Wen-Yu Hu, PHD, National Taiwan University, Department of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201101071RC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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