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

NCT ID: NCT01341210

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-02-28

Brief Summary

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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

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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

Conditions

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Lung Cancer Liver Cancer

Keywords

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Patients Satisfaction Decision Making Informed Consent

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

National Taiwan University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wen-Yu Hu, PHD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University, Department of Nursing

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ming-Tzu Wu, Master

Role: CONTACT

Phone: +886-926257263

Email: [email protected]

Facility Contacts

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Wen-Yu Hu, PHD

Role: primary

Other Identifiers

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201101071RC

Identifier Type: -

Identifier Source: org_study_id