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

NCT01341210 | Unknown

• 1 other identifier: 201101071RC
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Liver Cancer

Keywords

Patients Satisfaction; Decision Making; Informed Consent

Outcome Measures

Primary Outcomes (1)

• The influencing factors of behavior intentions towards participating in clinical trials

  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 Outcomes (4)

• 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

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients who have conscious disorientation that can not answer questionnaire
• Patients only participate in some Gene clinical trials without treatment or drugs.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Wen-Yu Hu, PHD

  National Taiwan University, Department of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Tzu Wu, Master

CONTACT

+886-926257263; r98426005@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 25, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

TW (1)