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.
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