Clinical trial NCT01341210: Observational Study of the Decision Making Towards Clinical Trials in Cancer Patients
Official title: The Study of the Knowledge, Attitudes, and Decision Making Towards Clinical Trials in Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Liver Cancer
Keywords: Patients Satisfaction
Decision Making
Informed Consent
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 116
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, cancer patients who have experience in contact with clinical trials

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The influencing factors of behavior intentions towards participating in clinical trials
timeFrame: in 24 months
Secondary outcomes:
measure: The knowledge towards clinical trials in cancer patients
timeFrame: 24 months
measure: The attitudes towards clinical trials in cancer patients
timeFrame: in 24 months
measure: The shared decision making level towards clinical trials in cancer patients
timeFrame: 24 months
measure: The subjective norm and behavior intentions towards clinical trials in cancer patients
timeFrame: 24 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University, Department of Nursing
name: Wen-Yu Hu, PHD
role: PRINCIPAL_INVESTIGATOR
References: