UNDERSTANDING
2.7 STUDIES ASSESSING UNDERSTANDING OF CANCER TRIAL PARTICIPANTS
The current section by focusing on persons with limited decision making capacity, has highlighted challenges that researchers may face in conducting research with persons with limited decision making abilities (including both patients and surrogates). The next section focuses on participants from oncology trials.
2.7 STUDIES ASSESSING UNDERSTANDING OF CANCER TRIAL
college education, presence of a nurse and careful reading of the consent were, among others, associated with increased understanding. Only 46 percent of the respondents recognised that the main reason for clinical trials was to assist future patients. This finding may reflect the biased information that researchers may provide to potential participants during the informed consent process or the desperation of those seeking treatment for an incurable illness. The findings may also reflect a confusion between researchers’ purposes and the trial participants’
own purposes. The authors (Joffe et al., 2001a) observed that their pilot sample scored higher on perceived understanding than on observed or measured understanding. However, when they measured the two levels of understanding using participants from various trials, they found self assessment and the measured scores were significantly correlated. The authors did not explain the contents of the template that was used in the study.
In a study conducted to assess the readability of informed consent forms that describe clinical oncology protocols, Grossman, Piantadosi and Covahey (1994) collected 137 consent forms from 88 protocols that were recruiting patients at one hospital. For each consent form, three readability indices were obtained, namely the Flesch Reading Ease score, the grade level readability score as determined by the Flesch-Kincaid formula, and the Gunning Fog index.
The study concluded that consent forms for oncology trials were written at a level that was difficult for most patients to read, despite the fact that the consent forms would have been reviewed by various parties, including institutional review boards. They recommended that the informed consent needs to be strengthened by improving readability of the informed consent forms.
A similar study which focused on readability and lengths of informed consent forms was conducted by Sharp (2004). The study revealed that none of the 107 forms collected were written at below the 8th grade reading level. The study concluded that consent forms in
oncology trials were so lengthy and complex that patients are not interested in reading them or are even able to understand the concepts discussed. Sharp also reported that institutional review boards (IRBs) are not interested in lowering the readability levels of informed consent documents. This study has implications for the role of IRBs in ensuring that study participants can understand the documents that they are asked to sign.
A study was conducted with the aim of assessing willingness to participate in oncology trials by Ellis, Butow, Tatersall, Dunn and Housammi (2001). The team conducted a cross-sectional survey among women attending a breast cancer clinic for screening and treatment, to assess attitudes towards and willingness to participate in randomised clinical trials of breast cancer treatment. They found that 33 percent would consider participating in a clinical trial if they had breast cancer. Women with breast cancer (30 percent) were more likely to decline to
participate than women attending for screening (15 percent) or diagnostic assessment (15 percent). Women who indicated that they would consider participation were more knowledgeable about randomised trials.
A qualitative study conducted in Australia indicated that patients who demonstrated greater knowledge about the clinical trial were less willing to participate in the trial (Ellis & Butow, 1998). In this study, 21 mothers and grandmothers were recruited in addition to 21 breast cancer patients. The study established that most women had some knowledge about randomisation but were neither aware of its purpose nor of how it was going to be achieved.
The study highlights the importance of context in disclosure of information as highlighted in the conceptual framework discussed in Chapter 3. The study specifically highlights the challenge of explaining a trial to a potential participant immediately after diagnosis with a disease such as cancer. The authors call for the need to educate the public about research so as to ensure that they are aware of clinical trials and how they are conducted. With a public
sensitization programme on clinical trials in place, researchers could only concentrate on addressing issues that are specific to their study such as the procedures, risks and benefits.
In a descriptive qualitative study which was aimed at assessing knowledge and understanding of oncology trial protocol, Barrett (2005) distributed a questionnaire to 17 patients who had agreed to participate in an oncology trial. Only eight of the 17 responded. The questionnaire focused on knowledge of informed consent and the oncology protocol for which they had enroled. Results indicated that participants had a good overall understanding of the elements of informed consent as well as the trials for which they had enroled. Interestingly, half of the respondents failed to understand that treatments in these clinical trials were not standard treatments and could involve some additional risk when compared to standard treatments. The author concluded that the Quality of Informed Consent (QUiC) questionnaire may be a useful tool in providing feedback on trial participants’ understanding of the elements of informed consent and that the feedback could be used in providing additional information in areas of need. Barrett recommended that there is need for more research on the development of reliable tools that can be used in assessing understanding as well as interventions aimed at improving understanding of the research process.
The current section has highlighted the effect of desperacy in informed consent, a characteristic which may be common among cancer patients. Such a characteristic may also obtain in poorly resourced communities where individuals may look up to clinical trials for some benefits. The next section focuses on studies conducted in developed countries to assess trial participants understanding of research participation.