Caroline B. Burnett

Impact of Quality of Life on Patient Expectations Regarding Phase I Clinical Trials

PURPOSE Quality of life (QOL) is increasingly recognized as a critical cancer-treatment outcome measure, but little is known about the impact of QOL on the patient decision-making process. A pilot study was conducted in an effort to (1) measure the expectations of patients, physicians, and research nurses regarding the potential benefits and toxicities from experimental and standard therapies, and (2) determine the relationship of QOL to patient perceptions regarding treatment options. METHODS Thirty cancer patients enrolling in phase I clinical trials, their physicians, and their research nurses were administered questionnaires that assessed demographics, QOL, and treatment expectations. RESULTS Compared with their physicians, patients overestimated potential benefits and toxicities from experimental therapy (mean expected benefit, 59.8% v 23.8%, P <.01; mean expected toxicity, 29.8% v 16.0%, P <.01). Patients estimated a greater potential for benefit (59.8% v 36.8%, P <.01) and less potential for toxicity (29.8% v 45.6%, P =.01) for experimental therapy, compared with standard therapy. Short Form-36 general health perception correlated with patient perception of potential benefit from experimental therapy (r =.48, P =.01). CONCLUSION Participants in phase I clinical trial have high expectations regarding the success of experimental therapy and discount potential toxicity. Patient QOL may affect the expectation of benefit from experimental therapy and, ultimately, treatment choice. Understanding the interactions between QOL and patient expectations may guide the development of improved strategies to present appropriate information to patients considering early-phase clinical trials.

The correlation between patient characteristics and expectations of benefit from phase I clinical trials

Patients in Phase I clinical trials sometimes report high expectations regarding the benefit of treatment. The authors examined a range of patient characteristics to determine which factors were associated with greater expectations of benefit from Phase I trials.

Acceptability of diagnostic tests for breast cancer

AbstractPurpose. To assess the acceptability of new non-invasive breast cancer diagnostic tests intended to triage women in need of biopsy. Methods. Women who had abnormal screening tests and had been recommended to have a biopsy were invited to receive digital mammography, magnetic resonance imaging (MRI), and nuclear medicine evaluation (Tc-99m-sestamibi scanning) before biopsy. Participants completed a questionnaire about satisfaction and acceptability of the procedures. Satisfaction measured womens overall and test-specific satisfaction. Acceptability was measured by self-reported discomfort, embarrassment and womens preference in terms of willingness to pay to avoid a biopsy. Results. Women were satisfied with all of the potential diagnostic triage procedures. Most found the tests more comfortable than a routine mammogram (47, 50, and 66% undergoing MRI, digital mammography, and sestamibi scanning, respectively). Women who provided a response to willingness to pay questions (N=43) were willing to pay an average of

An Exploration of Relative Health Stock in Advanced Cancer Patients

611 to have a test instead of a biopsy, if the test was as accurate as biopsy. The willingness to pay significantly decreased to

Decisional conflict among patients who accept or decline participation in phase I oncology studies.

308 if the test only had 95% accuracy. Those who had prior benign breast disease were less willing to pay for a test with 95% accuracy than those without this history. Conclusion. Instead of immediate biopsy after an abnormal screening, these results suggest that women would find non-invasive triage tests acceptable, or preferable to biopsy if they were equally accurate or nearly equally accurate as a biopsy. New technologies to diagnose breast cancer should focus on decreasing discomfort as well as increasing test accuracy.

Low-Income, Minority Women

Objective. The authors sought to empirically test whether relative health stock, a measure of patients’ sense of loss in their health due to illness, influences the treatment decisions of patients facing life-threatening conditions. Specifically, they estimated the effect of relative health stock on advanced cancer patients’ decisions to participate in phase I clinical trials. Method. A multicenter study was conducted to survey 328 advanced cancer patients who were offered the opportunity to participate in phase I trials. The authors asked patients to estimate the probabilities of therapeutic benefits and toxicity, their relative health stock, risk preference, and the importance of quality of life. Results. Controlling for health-related quality of life, an increase in relative health stock by 10 percentage points reduced the odds of choosing to participate in a phase I trial by 16% (odds ratio = 0.84, 95% confidence interval = 0.72, 0.97). Conclusion. Relative health stock affects advanced cancer patients’ treatment decisions.

Perceptions of Patients and Physicians Regarding Phase I Cancer Clinical Trials: Implications for Physician-Patient Communication

We compared decisional conflict among adults with advanced cancer who had accepted or declined participation in phase I cancer clinical trials. Respondents completed a 121-item questionnaire that included the Decisional Conflict Scale (DCS), which was designed to measure uncertainty in making health decisions. We used standardized effect sizes to compare the DCS scores of accepters (n = 250) and decliners (n = 65). Accepters had lower decisional conflict than decliners overall (d = 0.42; 95% confidence interval, 0.17–0.68) and on all subscales. Whether greater decisional conflict among decliners represents suboptimal decision-making and is reason for bioethical concern depends on how the results are interpreted. We offer three scenarios to explain the differences and describe opportunities for future empirical work.

Communication Between Physicians and Older Women With Localized Breast Cancer: Implications for Treatment and Patient Satisfaction

Bamers to access and use of cancer screening services by low-income, uninsured, minority women (underserved) have been related to increased morbidity and mortality in this group.’ Such barriers may include demographic (e.g., age, race, and socioeconomic status) and contextual variables (e.g., personal history of cancer, history of previous cancer screening tests, patient-provider relationships, and health care system variables), personal attitudes (e.g., knowledge and belief about efficacy of screening), and subjective norms (e.g., influence of significant others [SOs]). The purposes of this study were to (1) identify barriers to breast and cervical cancer screening services from the perspective of underserved women of the District of Columbia (D.C.) that may influence intentions to perform breast and cervical cancer screening behaviors [i.e., having a mammogram or Pap test within one year and performing monthly breast self-exam (BSE)], (2) determine the relationship of attitudes and subjective norms to intended behaviors as reported by underserved women, and (3) identify the relationship, if any, between the site where services are provided and underserved women’s intentions to perform cancer screening behaviors. The study was designed to address the following four hypotheses: