Robert L. Comis

Researchers, practitioners, and participants in cancer clinical trials must have a clear understanding of clinical trials if participation in them is to be solicited ethically and effectively. A valid and reliable measure of cancer clinical trial understanding did not exist prior to a 2005 study conducted for the Coalition of Cooperative Cancer Groups. This report outlines a measure derived from that study, discusses the rationale for its component items, examines its psychometric properties, and demonstrates the relationship of this measure to the enrollment decision. Data from national samples of cancer survivors and the general public demonstrate the measure's validity and reliability. Results are discussed as they relate to patient understanding of clinical trials, informed decision making, and health communication processes.

Purpose: To examine the attitudes of the public and cancer survivors toward their health-related decisions and cancer clinical trials (CCT) with a particular emphasis on the role of the physician, building on a 2003 report in Journal of Clinical Oncology. Methods: An Internet-based survey was performed in March through April 2005, using a subsample from Knowledge Networks' national probability sample of adults. One sample of 1,027 adults was selected to reflect a cross-section of the public. A second sample of 2,027 cancer survivors was selected from the Knowledge Networks adult panel, representing a probability sample of adult cancer survivors in 2005. Results: Both the public and cancer survivors rely mainly on their physicians as a key source of health-related information; their physicians are the most trusted health-care professional source of health information, although other sources such as the National Cancer Institute (NCI) and professional societies are also rated highly. All three sources rank significantly higher than the other 20 sources examined (P < .05). Only approximately 10% of survivors reported that they were aware of the possibility of CCT participation at the time of their diagnosis, and only 3% reported participation in a CCT. Seventy-three percent of patients aware of a CCT were made aware by a physician. Participation in a CCT was directly related to the level of physician involvement reported by the survivor (P < .01). Conclusion: The physician plays a critical role in CCT recruitment. Future increases in patient participation in a CCT will depend on the willingness of physicians to present, explain, and encourage patient enrollment when a CCT is a clinically relevant treatment approach.

The Oncologist is a journal devoted to medical and practice issues for surgical, radiation, and medical oncologists.

Lung cancer accounts for one-third of all cancer deaths worldwide. Once considered untreatable, lung cancer patients now have several different treatment options, and the potential for more effective therapies is promising. Clinical trials conducted during the past 25 to 30 years in the United States Cooperative Group System and throughout the world have defined the standard of care and made several initial treatment therapies possible. This article includes a summary of major findings of significant trials for varying disease stages; reviews major drug developments; and includes and a discussion of unanswered questions and trials currently underway that may provide the answers. Depending on the stage of disease, various therapeutic combinations can be effective in improving the time to progression, response, safety, and survival of lung cancer patients. Much has been accomplished on behalf of lung cancer patients. However, 80% to 90% of patients who develop lung cancer will die of their disease. Many questions remain to be answered, especially in the area of targeted therapies.

Purpose: The objective of this study is to understand the attitudes of American adults toward participation in cancer clinical trials. Methods: A national probability sample of 1,000 adults aged 18 and older living in noninstitutional settings was interviewed by telephone by Harris Interactive during March and April 2000. One participant was selected from each household selected for the study. The resulting data were weighted to reflect the full adult population of the United States as reported in Current Population Reports. An Index of Participation in a Cancer Clinical Trial was computed, using a confirmatory factor analysis and converting the factor scores into a 0-to-100 scale. Results: Approximately 32% of American adults (64 million individuals) indicate that they would be very willing to participate in a cancer clinical trial if asked to do so. An additional 38% of adults (76 million individuals) scored in a range that indicates that they are inclined to participate in a cancer clinical trial if asked, but hold some questions or reservations about participation. Projected rates of diagnosis, eligibility, and recruitment indicate that substantially more patients are willing to participate than are actually accrued. Conclusion: These results indicate that the primary problem with accrual is not the attitudes of patients, but rather that the loss of potential participants is the result of the unavailability of an appropriate clinical trial and the disqualification of large numbers of patients. The pool of willing patients is further reduced by the reluctance of some physicians to engage in accrual.