2.50
Hdl Handle:
http://hdl.handle.net/10755/621769
Category:
Full-text
Format:
Text-based Document
Type:
Presentation
Level of Evidence:
N/A
Research Approach:
N/A
Title:
Informed Consent Practice in Cancer Clinical Trials in Taiwan
Other Titles:
Global Concerns for Cancer Clinical Trials
Author(s):
Kao, Chi-Yin; Huang, Mei-Chih
Lead Author STTI Affiliation:
Non-member
Author Details:
Chi-Yin Kao, PhD, RN, Professional Experience: 2015-present Assistant Professor at Department of Nursing, National Cheng Kung University, Taiwan 2013-present Secretary-General, Taiwan Academy of Clinical Research Nurses (TACRN), Taiwan 2007-2009 Clinical Research Nurse, Department of Oncology, National Taiwan University, Taiwan Author Summary: Dr Kao is a clinical nurse specialist in cancer care with interests in clinical trial, palliative care, and ethical issues. She also devotes herself to Taiwan Academy of Clinical Research Nurses, assisting with development of clinical research nurses’ education, welfare, and certificate in Taiwan.
Abstract:

Purpose: To understand the current informed consent process in cancer clinical trials in Taiwan.

Methods: Using semi-structured interview guides to interview clinical research nurses and cancer patients. Content analysis was used to analysis the data.

Results: 10 clinical research nurses and 10 cancer patients were interviewed from three medical centers in Taiwan. From clinical research nurses' practice, informed consent of cancer clinical trials normally happen on a very stressful situation for patients after they were informed bad news regarding their cancer progression by physicians. If the patient is not ready for the informed consent, clinical research nurses normally explain the trial information to family members first and let family members discussed with patients. Therefore, family member is an important role in patient decision making under Taiwanese culture context. In order to achieve patient understanding, informed consent is a continuous communication process for clinical research nurses. Both clinical research nurses and patients reported that trust physician, a hope for personal benefits, no standard treatment options, financial considerations, and special care services are the main reasons for patients to enroll in a cancer clinical trial. Fear of possible risks and adverse effects of study drugs, time investment and travel, and frequent tests were repeatedly addressed as the main barriers to trial participation. More than 70% of patients reported that they made the decision to attend a trial treatment and signed the consent form directly after informed consent. Over 50% of participants mentioned that the language of the consent form was too hard to understand and after they finished reading, they still did not understand the information. Clinical research nurses indicated that patient misunderstanding/poor understanding of clinical trial, trust of recommendation from their physician and different opinions with physicians are the dilemmas of informed consent.

Conclusion: Information, comprehension and voluntariness are three essential elements of the consent process. However, our interview study indicated that patients receive a trial treatment is because they are under the pressure of disease progression and choose to trust their physician's recommendation, not based on understanding of trial information. Further research could be conducted to improve patient autonomy and understanding of cancer clinical trials.

Keywords:
cancer; clinical trial; informed consent
Repository Posting Date:
10-Jul-2017
Date of Publication:
10-Jul-2017
Other Identifiers:
INRC17O10
Conference Date:
2017
Conference Name:
28th International Nursing Research Congress
Conference Host:
Sigma Theta Tau International
Conference Location:
Dublin, Ireland
Description:
Event Theme: Influencing Global Health Through the Advancement of Nursing Scholarship

Full metadata record

DC FieldValue Language
dc.language.isoen_USen
dc.type.categoryFull-texten
dc.formatText-based Documenten
dc.typePresentationen
dc.evidence.levelN/Aen
dc.research.approachN/Aen
dc.titleInformed Consent Practice in Cancer Clinical Trials in Taiwanen_US
dc.title.alternativeGlobal Concerns for Cancer Clinical Trialsen
dc.contributor.authorKao, Chi-Yinen
dc.contributor.authorHuang, Mei-Chihen
dc.contributor.departmentNon-memberen
dc.author.detailsChi-Yin Kao, PhD, RN, Professional Experience: 2015-present Assistant Professor at Department of Nursing, National Cheng Kung University, Taiwan 2013-present Secretary-General, Taiwan Academy of Clinical Research Nurses (TACRN), Taiwan 2007-2009 Clinical Research Nurse, Department of Oncology, National Taiwan University, Taiwan Author Summary: Dr Kao is a clinical nurse specialist in cancer care with interests in clinical trial, palliative care, and ethical issues. She also devotes herself to Taiwan Academy of Clinical Research Nurses, assisting with development of clinical research nurses’ education, welfare, and certificate in Taiwan.en
dc.identifier.urihttp://hdl.handle.net/10755/621769-
dc.description.abstract<p><strong>Purpose: </strong><span>To understand the current informed consent process in cancer clinical trials in Taiwan.</span></p> <p><strong>Methods: </strong>Using semi-structured interview guides to interview clinical research nurses and cancer patients. Content analysis was used to analysis the data.</p> <p><strong>Results: </strong>10 clinical research nurses and 10 cancer patients were interviewed from three medical centers in Taiwan. From clinical research nurses' practice, informed consent of cancer clinical trials normally happen on a very stressful situation for patients after they were informed bad news regarding their cancer progression by physicians. If the patient is not ready for the informed consent, clinical research nurses normally explain the trial information to family members first and let family members discussed with patients. Therefore, family member is an important role in patient decision making under Taiwanese culture context. In order to achieve patient understanding, informed consent is a continuous communication process for clinical research nurses. Both clinical research nurses and patients reported that trust physician, a hope for personal benefits, no standard treatment options, financial considerations, and special care services are the main reasons for patients to enroll in a cancer clinical trial. Fear of possible risks and adverse effects of study drugs, time investment and travel, and frequent tests were repeatedly addressed as the main barriers to trial participation. More than 70% of patients reported that they made the decision to attend a trial treatment and signed the consent form directly after informed consent. Over 50% of participants mentioned that the language of the consent form was too hard to understand and after they finished reading, they still did not understand the information. Clinical research nurses indicated that patient misunderstanding/poor understanding of clinical trial, trust of recommendation from their physician and different opinions with physicians are the dilemmas of informed consent.</p> <p><strong>Conclusion: </strong>Information, comprehension and voluntariness are three essential elements of the consent process. However, our interview study indicated that patients receive a trial treatment is because they are under the pressure of disease progression and choose to trust their physician's recommendation, not based on understanding of trial information. Further research could be conducted to improve patient autonomy and understanding of cancer clinical trials.</p>en
dc.subjectcanceren
dc.subjectclinical trialen
dc.subjectinformed consenten
dc.date.available2017-07-10T20:25:43Z-
dc.date.issued2017-07-10-
dc.date.accessioned2017-07-10T20:25:43Z-
dc.conference.date2017en
dc.conference.name28th International Nursing Research Congressen
dc.conference.hostSigma Theta Tau Internationalen
dc.conference.locationDublin, Irelanden
dc.descriptionEvent Theme: Influencing Global Health Through the Advancement of Nursing Scholarshipen
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