BACKGROUNDThe multiple determinants of a patient's decision to enter into a clinical trial have been explored largely from the perspectives of patients and their physicians. Little research has involved clinical research associates (CRAs) formally, despite their central role in the process of recruitment. The current study was initiated to explore the factors that influence the decision of patients with cancer regarding clinical trial entry, specifically from the perspective of the CRA.METHODSTwo focus groups of CRAs from the Hamilton Regional Cancer Center were organized. A skilled facilitator guided both groups through exploratory and subsequent confirmatory phases of discussions, which were audiotaped for review and coding using a process of consensus employing intercoder triangulation.RESULTSThe two groups identified a number of factors that they believed influenced the recruitment process. Numerous physician and patient factors were reaffirmed, such as the impression of the scientific merit of a study or the sense of personal benefit, respectively. More uniquely, CRAs identified information transfer within the informed consent process as a major aspect of their specialized role. It was believed that full disclosure of information, in terms of both the content and the techniques and styles of delivery, was an important predictor of recruitment success. The groups quickly reached consensus on which factors they believed were the most important overall with respect to influencing study recruitment.CONCLUSIONSCRAs appear to have a unique role in the process of recruiting patients to active clinical trials. They believe that they have an important influence on recruitment success. Further research to validate this impression is required, because, ultimately, a greater understanding of the relative roles of physician and patient factors and, potentially, CRA factors will be important in the development of ethical and supportive strategies to optimize the recruitment of patients with cancer into randomized clinical trials. Cancer 2002;95:1584–91. © 2002 American Cancer Society.DOI 10.1002/cncr.10864

The IHA improved documentation of supportive care needs and resources. There is still room for improvement.

Fatigue is one of the most prevalent side effects of cancer, yet clinicians may not focus on it during busy clinic appointments. The purpose of this project was to evaluate the psychometric properties of a new two-item instrument designed to quickly identify patients experiencing difficulties with fatigue. The evaluation was conducted with 190 lung cancer patients attending ambulatory clinics. The Fatigue Pictogram had good reliability for test-retest over a 24-hour period (Weighted Kappa 0.71 for Question 1 and 0.72 for Question 2) and for equivalence of method (in person versus phone) (Weighted Kappa 0.64 for Question 1 and 0.65 for Question 2). Validity was assessed by comparing results of the new tool against the Multidimensional Fatigue Inventory and the SF-36. Overall, patients who indicated high fatigue levels did so on all respective scales. The new Fatigue Pictogram was easy to administer and score in a busy clinical setting. It provides a standardized reliable and valid instrument to identify patients experiencing difficulty with fatigue.

Fatigue is one of the most prevalent and distressing side effects of cancer for patients. It threatens quality of life and can interfere with daily living. Systematic approaches for assessing and intervening are recommended for implementation in many cancer centres. Prior to implementing a formal fatigue program, this study was conducted to explore what cancer patients do to cope with fatigue on their own. In-depth interviews were conducted with 31 patients receiving chemotherapy to identify the strategies they used to cope with the fatigue they experienced. Patients were able to identify when they noticed the fatigue and what they had tried to do. Most individuals used resting, sleeping, and decreasing activity. Relatively few tried a range of other strategies. Many perceived the fatigue as a normal part of cancer treatment and something with which they just had to put up. Heightened emotional reactions emerged when the fatigue interfered with an activity that was important to the individual. Clearly, without a systematic patient education program, patients are left to learn through trial and error what could be helpful to them in coping with the effects of fatigue.

The diagnosis of cancer of the central nervous system (CNS) is often the diagnosis of an incurable, progressive disease with devastating effects on the physical, psychosocial, and cognitive functioning of patients. Because many of the treatment options are noncurative in nature, issues related to quality and quantity of life become paramount. The purpose of the authors' research was to explore the prevalence of psychosocial needs in this cancer population and to determine whether these needs and their resolution impact on quality of life (QOL). Telephone interviews were conducted with 75 patients in whom primary CNS cancer was diagnosed and who were able to pass the Mini-Mental Health Status Examination. Analysis of results indicated that the majority of patients (97.3%) had at least one concern; concerns over treatment side effects, controlling uncertainty, having a meaningful existence, self and body image, and family concerns were among the five most frequently cited need domains. Most patients (91.8%) received help. However, 75.3% reported needing additional help. The number of needs reported and the severity of fatigue most significantly impacted QOL. The study identified the needs and experiences of the patient with CNS cancer. Quality of life and needs assessment information can be used to screen patients for distress and to measure the outcome of medical and psychosocial care and ultimately to ease the burden of illness.