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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. [ABSTRACT FROM AUTHOR]

PURPOSE/OBJECTIVES: To identify nurses' attitudes and beliefs toward cancer clinical trials and their perceptions about factors influencing patients' participation in these trials. DESIGN: Descriptive. SETTING: National Cancer Institute-designated comprehensive cancer center. SAMPLE: 417 nurses employed at the cancer center were surveyed; 250 (60%) subjects responded. METHODS: 59-item questionnaire. MAIN RESEARCH VARIABLES: Nurses' attitudes toward clinical trials and perceptions of patient understanding of and influences on participation in clinical trials. FINDINGS: 96% of nurses reported that participation in clinical trials is important to improving standards of care; only 56% believed that patients should be encouraged to participate in trials if they had cancer. In multiple regression analyses, older age and being a research nurse were significant predictors of positive attitudes toward clinical trials. Work setting also was a significant predictor of nurses' perceptions of patients' understanding of treatment. Overall, nurses reported that an investigational therapy should have at least a 50% chance of success prior to being offered to patients. CONCLUSIONS: Nurses generally reported that clinical trials are important to improve standards of care; however, attitudes concerning patient participation in clinical trials and perceptions of patient understanding differed by work setting. Nurses have high expectations regarding the benefits of investigational therapy. IMPLICATIONS FOR NURSING PRACTICE: Nurses play a critical role in the care of participants in cancer clinical trials. Targeted interventions that involve nurses to enhance appropriate patient accrual, patient understanding, and patient decision making should result in improved patient care in centers conducting clinical trials. [ABSTRACT FROM AUTHOR]

PURPOSE/OBJECTIVES: To explore factors that influence an individual's decision to participate in phase I cancer clinical trials. DESIGN: Exploratory, descriptive, and qualitative study. SETTING: Outpatient oncology clinic of a comprehensive cancer center in an urban setting. SAMPLE: 22 patients with cancer who had been asked at some point during their treatment to participate in a phase I cancer clinical trial were invited to participate in a focus group. Eight patients participated. METHODS: Two focus groups were conducted. MAIN RESEARCH VARIABLES: Factors that influenced patients' decisions to participate in a phase I cancer clinical trial. FINDINGS: Participants expressed that hope for a cure and trusting the oncologist's advice were the primary factors that influenced their decisions to participate in phase I research. The majority expressed surprise that anyone would participate in an experimental study for altruistic reasons. CONCLUSIONS: Patients choose to hope for some personal benefit from their participation in phase I clinical trials even though they realized that is not the purpose or goal of the trial. IMPLICATIONS FOR NURSING PRACTICE: Nurses are in an ideal position to offer information to individuals who are deciding whether to participate in a phase I cancer clinical trial. However, most nurses are not seizing this opportunity. Patients are unable to describe nurses' impact on their decision to enter a phase I cancer clinical trial. [ABSTRACT FROM AUTHOR]

Background: Women with a family history of breast cancer (i.e., in a mother, sister or daughter) are at increased risk for this disease. Previous data also suggest that lesbians are at increased risk for breast cancer. While the screening behaviors of women with a family history have been described, little is known about factors that influence screening behaviors of lesbians with the same risk factor profile. Purpose: The purpose of this study was to characterize the perceptions of susceptibility to breast cancer and describe factors that influthe mast important combinations of factors. Outcome measures were age-specific adherence to ACS guidelines for both mammography and overall adherence (i.e., mammography, clinical breast examination and breast self-examination). Results: The 139 lesbians interviewed for this study were young (mean age = 43), almost exclusively white (94%), highly educated (78% = college graduate and beyond), and partnered (68%). In the bivariate analysis of individual factors, being employed and reporting breast cancer worries were significantly and positively associated with adherence to mammography guidelines. Higher income and insurance type were significantly associated with mammography adherence. No factors were significantly associated with overall adherence. Multivariate logistic regression analyses revealed that only income level and degree of breast cancer worries were significantly and positively associated with mammography adherence. However, since there was a high correlation between income level and employment status, a regression model with employment status and worry was also significantly related to mammography adherence. Conclusions: In lesbians who are at an increased risk for breast cancer because of family history, breast cancer worries may motivate, rather than deter, adherence for mammography use. High income levels also appear to enable adherence in this population. Implications: Additional studies are needed to validate these findings, identify the prevalence of lesbians in general samples of women at increased risk for breast cancer, and prospectively test lesbian sensitive educational intervention strategies designed to facilitate adherence to mammography screening guidelines in this population. [ABSTRACT FROM AUTHOR]

Purpose: To identify if baseline patient or magnetic resonance imaging (MRI) features can predict which women are at risk for inadequate tumor coverage with only intracavitary tandem and ovoid (T + O) brachytherapy and to correlate tumor coverage with clinical outcomes., Methods and Materials: We performed a retrospective study of 50 women with cervical cancer treated with chemoradiation at a single institution between January 2014 and December 2015. All patients had a 3T-MRI performed at baseline (MRI1) and at the completion of external beam radiation therapy (MRI2). Gross tumor volume initial (GTV-T init ) was measured on MRI1 and high-risk clinical tissue volume (CTV HR ) on MRI2. CTV HR extending beyond point A was classified as too large for adequate coverage with T + O and requiring interstitial needles. Multivariate analysis was performed to determine predictive factors of inadequate coverage. Kaplan-Meier and Cox Regression were performed to correlate inadequate coverage with outcomes., Results: Mean patient age was 49.2 ± 13.2 years, and 84% had Federation of Gynecology and Obstetrics IIB/IIIB disease. Forty-two percent of women were estimated to have inadequate tumor coverage with T + O brachytherapy. The GTV-T init volume and dimensions (superior-inferior, left-right, anterior-posterior) on MRI1 were all important predictive factors of inadequate coverage on multivariate analysis. Receiver operating characteristics curves identified optimal thresholds of superior-inferior ≥ 4.5 cm (area under the curve [AUC] = 0.718), left-right ≥ 4.5 cm (AUC = 0.745), anterior-posterior ≥ 5.0 cm (AUC = 0.767), and GTV-T init ≥ 85 cm 3 (AUC = 0.842). Patients with inadequate coverage had worse clinical outcomes., Conclusions: Baseline MRI tumor size may predict inadequate CTV HR coverage at the time of brachytherapy (i.e., the need for interstitial needles). This may help identify a subset of women requiring early referral to adequately resourced centers to improve clinical outcomes., (Copyright © 2018 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

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.

Objectives: To study the efficacy, safety, and tolerability of the 300 microg dose of a new chromatographically produced rhesus immunoglobulin (Rhophylac 300) for ante- and postnatal rhesus prophylaxis., Design: In an open-label multi-centre study, rhesus D (RhD)-negative women were randomly allocated to receive Rhophylac 300 either intravenously or intramuscularly at the 28th week of gestation and within 72 h after delivery of an RhD-positive child. Serum samples were obtained prior to the antenatal dose and 6-11.5 months after delivery of an RhD-positive child and tested by the indirect antiglobulin test and papain test for anti-D. Safety parameters were assessed in all women who were treated with the study drug., Results: Four hundred and thirty two women received the study drug antenatally. No differences were detected in efficacy or tolerability between intravenous and intramuscular administration. Of the 261 women who delivered an RhD-positive child and received rhesus prophylaxis according to the protocol, 248 women returned for follow-up investigations. None of them had detectable anti-D at their last visit. There were no serious adverse events, no cases of infectious disease transmission nor clinically relevant changes in laboratory safety values and vital signs attributable to the study drug., Conclusions: The results suggest that Rhophylac 300 given intravenously or intramuscularly is safe and efficacious in preventing rhesus (D) immunisation.

Purpose: To describe and compare the perceptions of cancer patients and their physicians regarding phase I clinical trials., Methods: Eligible patients had been offered phase I trial participation and had decided to participate but had not yet begun treatment. Each patient's physician also served as a study subject. Patients and physicians completed questionnaires with domains including perceptions of potential benefit and harm from treatment (experimental and standard), relative value of quality and length of life, and perceived content of patient-physician consultations., Results: Three hundred twenty-eight patients and 48 physicians completed surveys. Patients had high expectations regarding treatment outcomes (eg, median 60% benefit from experimental therapy), with those choosing to participate in a phase I trial being more optimistic than those declining phase I participation. Patients predicted a higher likelihood of both benefit and adverse reactions from treatment (experimental and standard) than their physicians (P <.0001 for all comparisons). Although 95% of patients reported that quality of life was at least as important as length of life, only 28% reported that changes in quality of life with treatment were discussed with their physicians. In contrast, 73% of physicians reported that this topic was discussed (P <.0001)., Conclusion: Cancer patients offered phase I trial participation have expectations for treatment benefit that exceed those of their physicians. The discordant perceptions of patients and physicians may possibly be explained by patient optimism and confidence; however, the discrepancies in reports of consultation content, particularly given patients' stated values regarding quality of life, raise the possibility that communication in this context is suboptimal.

Background: 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., Methods: Participants were adult patients with cancer who had been offered participation in Phase I studies and had decided to participate. Patients completed interviewer-administered surveys before initiation of treatment. Physicians assessed Eastern Cooperative Oncology Group performance status for each patient. Statistical analyses (Pearson product moment correlation and t tests) used multiple imputation to account for missing data., Results: Overall, 593 patients who were offered participation in Phase I trials were contacted, and 328 patients agreed to participate in a study of decision making by cancer patients. Of these, 260 patients (79%) enrolled in a Phase I trial. Patients' expectations regarding the chance that their disease would be controlled with experimental therapy were unrelated to age, gender, living situation, education level, or functional status. Expectations were correlated positively with beliefs about the benefit of standard therapy and the maximum benefit patients may experience from experimental therapy. Greater expectations of benefit were associated with better health-related quality of life, stronger religious faith, optimism, relative health stock, monetary risk seeking, and poorer numeracy., Conclusions: Expectations expressed as beliefs in personal outcomes may be related more to quality of life and personality variables than to patients' knowledge or functional status. Whether such expectations are accurate reflections of knowledge has important implications for evaluating the informed consent process., (Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11483)

Purpose: 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 women's overall and test-specific satisfaction. Acceptability was measured by self-reported discomfort, embarrassment and women's 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 611 dollars to have a test instead of a biopsy, if the test was as accurate as biopsy. The willingness to pay significantly decreased to 308 dollars 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.

Purpose: To identify factors associated with patient-physician communication and to examine the impact of communication on patients' perception of having a treatment choice, actual treatment received, and satisfaction with care among older breast cancer patients., Materials and Methods: Data were collected from 613 pairs of surgeons and their older (greater-than-or-equal 67 years) patients diagnosed with localized breast cancer. Measures of patients' self-reported communication included physician- and patient-initiated communication and the number of treatment options discussed. Logistic regression analyses were conducted to examine the relationships between communication and outcomes., Results: Patients who reported that their surgeons mentioned more treatment options were 2.21 times (95% confidence interval [CI], 1.62 to 3.01) more likely to report being given a treatment choice, and 1.33 times (95% CI, 1.02 to 1.73) more likely to get breast-conserving surgery with radiation than other types of treatment. Surgeons who were trained in surgical oncology, or who treated a high volume of breast cancer patients (greater-than-or-equal 75% of practice), were more likely to initiate communication with patients (odds ratio [OR] = 1.62; 95% CI, 1.02 to 2.56; and OR = 1.68; 95% CI, 1.01 to 2.76, respectively). A high degree of physician-initiated communication, in turn, was associated with patients' perception of having a treatment choice (OR = 2.46; 95% CI, 1.29 to 4.70), and satisfaction with breast cancer care (OR = 2.13; 95% CI, 1.17 to 3.85) in the 3 to 6 months after surgery., Conclusion: Greater patient-physician communication was associated with a sense of choice, actual treatment, and satisfaction with care. Technical information and caring components of communication impacted outcomes differently. Thus, the quality of cancer care for older breast cancer patients may be improved through interventions that improve communication within the physician-patient dyad.

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.

Clinical decision making and, broadly speaking, patient care are increasingly collaborative endeavors dependent on the integration of the profession-specific knowledge, skills, and perspectives of physicians and nurses. Conflicts over the ethical dimensions of clinical decision making often arise from these differing but complementary perspectives. Neither medical nor nursing education adequately prepares future clinicians for these realities of practice. At Georgetown University, students and faculty in medicine and nursing have developed an interdisciplinary curriculum in clinical ethics. The curriculum will bring together medical students and graduate nursing students with the aim of educating and training them to analyze and resolve dilemmas in clinical ethics critically and collaboratively.

Purpose/objectives: To describe women's perspectives on factors that influenced their decision to have reconstructive surgery after a breast cancer diagnosis., Design: Exploratory, descriptive, qualitative study., Setting: A comprehensive cancer center in an urban setting., Sample: Eleven women who underwent mastectomy and reconstruction. Six participants had autologous transverse rectus abdominis musculocutaneous-flap reconstruction, four had saline implants, and one had a silicone implant. All but one reconstruction was performed at the time of mastectomy., Methods: Open-ended, face-to-face interviews using an interview guide were conducted within one month of reconstruction. One to two follow-up interviews were conducted approximately six months later., Main Research Variables: Decision making about reconstruction, perceptions of information needs and sources, sources of support, and factors important to decision making., Findings: The main theme identified was Getting My Life Back. The participants described this in terms of the themes of Information Seeking, Talking It Over, and Seeking Normality. The interactive skills of the healthcare provider played an important role in the women's decision making., Conclusions: Reconstruction minimized the negative consequences of breast cancer and its treatment for the women in the study. The decision-making process was aimed at getting the person's life back as close to what it was before the diagnosis as possible or improving it. The three themes of decision making are interactive in nature, with participants returning to information Seeking and Talking It Over as necessary to increasing their understanding and clarifying their "normality goals.", Implications for Nursing Practice: Healthcare professionals should determine how a woman wants to participate in decision making as well as the kind, amount, and sources of information the individual with breast cancer wants to have to make her decisions. Healthcare providers are key sources of information about treatment options, and they are critical to patient satisfaction with the decision-making process and with the final results of the surgical procedure. Family members, friends, and other women with breast cancer play a crucial role in talking it over.

Purpose: This study examined coping responses in women diagnosed with Stage I or Stage II breast cancer., Methods: A convenience sample of 36 patients with breast cancer was administered the Reaction to Diagnosis of Cancer Questionnaire (RDCQ) at 2 days and 30 days postmastectomy., Results: No statistically significant differences were observed in RDCQ scores between 2 days and 30 days postmastectomy (t = -1.57, P = 0.127). However, a significant change in the mean difference of the RDCQ scores was observed in women who had immediate breast reconstruction when compared to those women who did not have reconstruction (t = -2.34, P = 0.037). Additional results indicated that age and RDCQ scores had an inverse relationship, and women who were employed had significantly lower RDCQ scores at 30 days postmastectomy, indicating less positive coping. The variables of marital status, educational level, and number of days since diagnosis were not significant., Clinical Implications: The results of this study may assist healthcare providers in understanding what affects coping in women diagnosed with early stage breast cancer.

Purpose/objectives: To identify barriers to breast and cervical cancer screening services from the perspective of medically underserved women of the District of Columbia (DC) that may influence intentions to perform breast and cervical cancer screening behaviors; to determine any relationship between attitudes and influence of significant others on intended behaviors; and to identify a relationship between the site where services are provided and the underserved women's intentions to engage in screening behaviors., Design: Cross-sectional, correlational., Setting: Breast and cervical cancer screening clinics in DC., Sample: 339 medically underserved, adult women., Methods: Face-to-face investigator-conducted interviews., Main Research Variables: Demographic and contextual variables as well as attitudes and influence of significant others. Intention to have a mammogram or Pap test or perform breast self-examination (BSE) monthly., Findings: Intention to have a mammogram was positively related to influence of significant others and negatively related to uncaring healthcare professionals. Intention to have a Pap test had a positive relationship with one's attitude toward the test and with the influence of significant others. Intention to perform BSE was positively related to attitude toward and previous performance of BSE and influence of significant others. No significant relationships were observed between intention to perform screening behaviors and demographic variables., Conclusions: Factors that influence women's attitudes toward screening and intention to perform these behaviors include previous screening behaviors, influence of significant others, and relationships with healthcare professionals., Implications for Nursing Practice: Oncology nurses are well-positioned to develop and test intervention strategies designed to increase access to and compliance with recommended screening guidelines among the medically underserved. Findings from this study potentially could guide development and evaluation of such strategies that are sensitive to this special population.