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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01341210
Collaborator
(none)
116
Enrollment
1
Location
36
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    116 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Study of the Knowledge, Attitudes, and Decision Making Towards Clinical Trials in Cancer Patients
    Study Start Date :
    Feb 1, 2011
    Anticipated Primary Completion Date :
    Feb 1, 2014
    Anticipated Study Completion Date :
    Feb 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. The influencing factors of behavior intentions towards participating in clinical trials [in 24 months]

      The influencing factors was defined as following measurement scale: Knowledge Attitude decision making process sex age education

    Secondary Outcome Measures

    1. The knowledge towards clinical trials in cancer patients [24 months]

    2. The attitudes towards clinical trials in cancer patients [in 24 months]

    3. The shared decision making level towards clinical trials in cancer patients [24 months]

    4. The subjective norm and behavior intentions towards clinical trials in cancer patients [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital, National Taiwan University Hospital, National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT01341210
    Other Study ID Numbers:
    • 201101071RC
    First Posted:
    Apr 25, 2011
    Last Update Posted:
    Aug 26, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by National Taiwan University Hospital, National Taiwan University Hospital, National Taiwan University Hospital
    Patients Satisfaction
    Decision Making
    Informed Consent
    Additional relevant MeSH terms:
    Liver Neoplasms

    Study Results

    No Results Posted as of Aug 26, 2013