The purpose of this meta-synthesis research was to synthesize a qualitative study performed to better understand the underlying reasons why only a fraction of cancer patients participate in cancer research trials. The attempt is to explore factors that influence participation in this type of study. Literature in the subject indicates poorly understood process of how patients are enrolled into clinical trials.
This systematic review tries to improve the patient decision-making process in participating in cancer clinical trial and to provide Oncology nurses to treat patients with solid background utilizing evidence based practice (Biedrzycki, 2010). The study was conducted in hope to eliminate misconceptions on the negative feelings of cancer clinical trials. A common misconception is participation can cause harm instead of cure. The report clearly describes how the variation in research design and methods revealed low percentages of cancer patient participation in previous studies.
An information specialist assisted with the selection of relevant studies. Data selection was reviewed through PubMed. Patient participation and decision making were topics reviewed. A PRISMA-type flow chart elaborates on the multiple studies reviewed (Biedrzycki, 2010). The criteria for reviewing articles included articles published since 2004. Research from other countries was reviewed and was not confined to the United States.
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Literature reviewed through the National Institutes of Health (NIH) roadmap for Medical Research, fortified the research by emphasizing important aspects of human research participants and transforming this into clinical research. 62 articles met criteria and 24 articles did not meet the initial criteria. Articles beyond five years provided evidence of inaccurate representation of the current views on patients’ will to participate in clinical trials (Biedrzycki, 2010). The research article indicates the sample sizes ranged from 16 to more than 115000 which yield a median=162.
The combined sample of participants includes gender, race, and age. Most participants were Caucasian. One study included only Asian women. Ages ranged from 50 to 64 years, median 57. 6 years. Cancer diagnoses were reported in 10 studies, six studies omitted reporting cancer as a diagnosis. Four studies reported advanced cancer. Six studies reported participation in phase I clinical trials. One study reported participation in a phase III clinical study. The rest of the studies did not report the phase of trials. There is no indication whether follow up was done with the original reporter to clarify missing information (Biedrzycki, 2010).
The criteria used to appraise the research consisted of decision-making process, communication, educational interventions, perceptions, benefits and burdens, quality of life, reasons for declining participation, knowledge, relative health stock, timing of consent, satisfaction, and decisional regret. Most studies focused on decision making, however; thirteen studies described multiple aspects of cancer clinical trial participation. Some studies focused on the psychosocial consequences of clinical trial decision making.
This data was appraised by several research team members (Biedrzycki, 2010). Decision-making instruments included the Llewellyn-Thomas, an unnamed instrument and the Homes-Rovner et al. Satisfaction with Decision Scale. Other instruments included the Understanding of Clinical Trials by Joffe et al. and The Decisional Regret Scale and the Karmonos Accrual Analysis System. Most studies did not report psychometric measures and almost all studies used one question to assess willingness, interest or knowledge about cancer clinical trials (Biedrzycki, 2010).
Data analysis is presented in table format. Table 1 consists of factors reflecting the rigor of the studies reviewed. Table 2 consists of measures of decision making used in the studies reviewed and Table 3 lists strengths, limitations, and key points of the studies reviewed. The studies were mainly descriptive, consisting of mixed-methods design. Three studies tested an educational intervention and two studies used an experimental design. 50% of the studies did not report timing of the research in relation to the decision regarding clinical trial participation (Biedrzycki, 2010).
During meta-analysis, response rates varied by type of measure and study design, only 50% reported response rates (range = 21% – 95%, median=71%. 29% declined participating because they had no interest and 24% declined with no reason given. One major reason people declined to participate was because they had no access or could not use a computer. Multiple time measures were conducted in decision regret, it was noted that responses were reduced (Biedrzycki, 2010). The process used to pool the data together was clinical trial decision making.
The main factors influencing this process consist of patient, provider, and treatment. Two studies specifically explored decision making by the patient. Education requirements impacted decision making since understanding the risks and benefits of clinical trials was the most important factor taken into consideration by the patient. Educational interventions were noted to have increased patient enrollment. (Biedrzycki, 2010). If the patient found the education from the provider to be coercive, treatment was considered a burden.
Time and travel also posed an inconvenience on the patient since it adversely affected quality of life and therefore deterred patients from cancer clinical trials. On a positive note, studies reported factors associated with positive decision making outcomes. Positive decision making included being more spiritual, younger, and having more advanced cancer, and having a good understanding of the education received. Several other aspects were indicated as positive decision making outcomes when providers introduced user-friendly systems (Biedrzycki, 2010).
The primary focus of the study was accepting or declining clinical trial participation. The secondary focus was decision-making and the silent variable was the influence on clinical trial participation. All criteria were elegantly spelled out in form of charts and tables. Figure 1 included factors associated with the decision to participate in a cancer clinical trial. Figure 2 revealed factors associated with a positive decision making outcome (Biedrzycki, 2010). A factor that was clearly noted as missing was a review on the process by which patients decide on whether or not to participate in clinical research trial.
Components of the decision making preferences have not been determined. Consenting for a research process is autonomous and the current healthcare system does did not provide sufficient learning opportunities for the patient to acquire enough information to make an adequate informed consent. When the patient lacks this knowledge and the healthcare provider lacks the understanding of the patient’s values, it is difficult for the patient to want to participate in clinical trials (Biedrzycki, 2010).
The reviewers concluded that future research is needed for continuation of exploring the reasons for lack of cancer patients’ participation in clinical research trials. The need for sound construct for decision making can prepare nurses and healthcare workers to understand the cancer patient’s values and to provide education that may enhance knowledge and strengthen interventions, and improve cancer clinical trial participation (Biedrzycki, 2010).
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