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Objective: The present study established the psychometric properties of the Functional Assessment of Cancer Therapy-Neutropenia (FACT-N), a self-report instrument to assess neutropenia-specific concerns and health-related quality of life (HRQL), in a sample of adults 65 years of age and older.Materials and Methods: Participants were undergoing chemotherapy for lung, breast, or ovarian cancer or non-Hodgkin's lymphoma (n = 852) and were randomly assigned to receive pegfilgrastim beginning with cycle 1 (primary prophylaxis) or pegfilgrastim subsequent to cycle 1 at their clinicians' discretion (usual care). Participants completed a self-report assessment on day 1 of each cycle (up to six cycles) and at the expected nadir of the white blood cell count of each cycle. Using factor analysis, three subscales were identified in the 19-item FACT-N subscale: Malaise, Worry, and Flu-like symptoms.Results and Discussions: The FACT-N and each of the subscales were sensitive to the presence of neutropenia although did not correlate with the absolute neutrophil count (ANC). While ANC is a marker of the impact of chemotherapy on the myeloid precursors of the bone marrow and is correlated with risk of febrile neutropenia, however the constellation of symptoms and patient experience vary throughout the period of neutropenia as the ANC first declines and then recovers. The 19-item neutropenia subscale can be used alone; however, evidence supporting reliability and validity was most robust for aggregate scores from the FACT-N and the Trial Outcome Index-Neutropenia (TOI-N).Conclusion: Understanding the impact of neutropenia on HRQL through the availability of a validated self-report measure will, ideally, lead to interventions to reduce the burden associated with cancer and its treatments. [ABSTRACT FROM AUTHOR] more...

For the past six years, the Chicago-area faith-based Reach Out Consortium has mobilized low-income uninsured and underinsured African American women and Latinas to seek screening for breast and cervical cancer. The funding history for this program illustrates how funds for a small community-based program were leveraged into a broader program, and that grew to serve low-income women across the state. Further, as the program reached more and more uninsured women, community activism led to a further state investment in services for the uninsured. Program sustainability and expansion depended on a combination of public and private competitive grants and grassroots advocacy. [ABSTRACT FROM AUTHOR] more...

Objective: Health-related quality of life (HRQOL) impairment may be a central component of chronic prostatitis for men afflicted with this condition. Our objective was to examine HRQOL, and factors associated with HRQOL, using both general and condition-specific instruments.Design: Chronic Prostatitis Cohort (CPC) study.Setting: Six clinical research centers across the United States and Canada.Participants: Two hundred seventy-eight men with chronic prostatitis.Measurements and Main Results: The Short Form 12 (SF-12) Mental Component Summary (MCS) and Physical Component Summary (PCS), and the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) were measures used. CPC subjects' MCS scores (44.0 +/- 9.8) were lower than those observed in the most severe subgroups of patients with congestive heart failure and diabetes mellitus, and PCS scores (46.4+/-9.5) were worse than those among the general U.S. male population. Decreasing scores were seen in both domains with worsening symptom severity (P < .01). History of psychiatric disease and younger age were strongly associated with worse MCS scores, whereas history of rheumatologic disease was associated with worse PCS scores. Predictors of more severe NIH-CPSI scores included lower educational level and lower income; history of rheumatic disease was associated with higher scores.Conclusions: Men with chronic prostatitis experience impairment in the mental and physical domains of general HRQOL, as well as condition-specific HRQOL. To optimize the care of men with this condition, clinicians should consider administering HRQOL instruments to their patients to better understand the impact of the condition on patients' lives. [ABSTRACT FROM AUTHOR] more...

Delays in initiating guideline-adherent postoperative radiation therapy (PORT) affect 50% of patients with head and neck squamous cell carcinoma (HNSCC), disproportionately burden racial minorities, are associated with worse survival, and contribute to racial disparities in mortality. This study tests the hypothesis that NDURE (Navigation for Disparities and Untimely Radiation thErapy), a patient navigation-based intervention, will decrease delays in starting guideline-adherent PORT relative to Usual Care (UC). This randomized clinical trial (RCT) included adults with locally-advanced HNSCC (i.e., oral cavity, oropharynx, hypopharynx, larynx or paranasal sinuses) planning to undergo curative-intent surgery and PORT. Preoperatively, patients were randomized to NDURE, a navigation-based intervention that addresses barriers to timely PORT at the patient-, healthcare team-, and organizational-levels, or UC. The primary endpoint was delay in initiating guideline-adherent PORT, defined as starting PORT > 6 weeks after surgery. The secondary endpoint was time-to-PORT (TTP). The difference in PORT delay between arms was evaluated using a binary regression generalized linear model with randomization stratification factors (race, expected PORT facility) as covariates. The difference in TTP between arms was evaluated by estimating hazard ratios (HRs) from Cox proportional hazards models, adjusting for stratification factors. Interactions between race and treatment arm were subsequently added to the binary regression and Cox models to compare racial disparities between arms. To detect a 20% reduction in the primary endpoint of PORT delay (45% vs 25%) assuming a two-sided α = 0.1 and power of 83%, we planned to accrue n=75 patients/arm evaluable for the primary endpoint, up to a total of n=180. Among 177 eligible patients randomized to NDURE (n=88) or UC (n=89), 146 patients underwent surgery and had a pathologic indication for PORT. NDURE decreased delays in initiating guideline-adherent PORT relative to UC (model-based PORT delay, 26% vs 61%; risk difference = -35%; 90% CI -48% to -23%; p < 0.001). Median TTP was 39 and 47 days in NDURE and UC, respectively. NDURE improved TTP relative to UC (HR = 1.92; 90% CI 1.43 to 2.58; p < 0.001). The difference in delays in initiating guideline-adherent PORT between Black and White patients was 12% in NDURE vs 24% in UC (p = 0.51). The difference in median TTP between Black and White patients was 1 day in NDURE vs 10 days in UC (NDURE Black/White HR = 0.89; 90% CI 0.48 - 1.53; UC Black/White HR = 0.65; 90% CI = 0.41 - 1.02; p = 0.53). In this RCT of patients with HNSCC undergoing surgery and PORT, NDURE decreased delays in starting guideline-adherent PORT and improved TTP. These data support conducting a large efficacy trial to evaluate patient navigation-based approaches to improving the timeliness and equity of PORT for patients with HNSCC and their effect on oncologic outcomes. [ABSTRACT FROM AUTHOR] more...

Background: Individualized breast cancer risk assessment can identify women at increased risk who are candidates for interventions with proven benefit, including chemoprevention, enhanced surveillance, genetic testing and risk-reducing surgery. Systematic risk assessment and prescription of individualized, risk-adapted cancer control recommendations provides a novel method for addressing cancer disparities in underserved minority women. Widespread dissemination of these approaches requires implementation in the primary care setting. Purpose: to determine potential benefits and harms of a policy for routinely providing personalized breast cancer risk assessment for underserved minority women from the perspectives of patients and primary care providers (PCPs), and to explore ethical implications of breast cancer risk communication in this patient population. Methods: African American and Hispanic women age 25-69 years without a history of breast cancer, presenting for a routine scheduled appointment with their primary provider at a Federally Qualified Health Center were invited to participate in a study on women's views about breast cancer risk. Breast cancer risk factor data was collected from all participants and individualized risk assessments were performed using three models (NCI BCRAT, Claus model and a pedigree assessment tool). PCPs discussed the results of the assessment with their patients and provided computer-generated, risk-adapted recommendations for screening and prevention that are based on national guidelines. Using a mixed methods approach, we collected quantitative survey data from participants at baseline (prior to receipt of risk information), immediately following the encounter with their PCP and two weeks later. We also used qualitative approaches in a subgroup of participants from each of three risk strata (general population risk, moderately-increased and high risk) including audio-recorded observational data from physician-patient interactions and in-depth interviews with patients and physicians in order to evaluate how women process risk information and make decisions regarding how to act on that information. Data collected broadly focused on the following topics: * Interpretation and initial reaction to the personalized risk information provided by the PCP * What it means to be "at (baseline, moderate, high) risk" * Views on value of/potential benefits and harms of personalized risk information * Level of trust in the information * Preferences regarding recommended surveillance strategies and risk reduction strategies (for moderate and high risk groups) * Preferences regarding shared decision making * Future plans/action steps based on personalized risk information * Perceptions of the manner that personalized risk information was presented to them by their PCP Results: We are planning to enroll 480 participants for the quantitative survey portion and 48 participants for in-depth qualitative data collection, including audio-recorded patient-physician interactions and in-depth patient interviews, along with 8 in-depth provider interviews. Data collection is ongoing and results will be presented. [ABSTRACT FROM AUTHOR] more...