Predictors of duloxetine response in patients with oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN): a secondary analysis of randomised controlled trial - CALGB/alliance 170601.

Duloxetine is an effective treatment for oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN). However, predictors of duloxetine response have not been adequately explored. The objective of this secondary and exploratory analysis was to identify predictors of duloxetine response in patients with painful oxaliplatin-induced CIPN. Patients (N = 106) with oxaliplatin-induced painful CIPN were randomised to receive duloxetine or placebo. Eligible patients had chronic CIPN pain and an average neuropathic pain score ≥4/10. Duloxetine/placebo dose was 30 mg/day for 7 days, then 60 mg/day for 4 weeks. The Brief Pain Inventory-Short Form and the EORTC QLQ-C30 were used to assess pain and quality of life, respectively. Univariate and multiple logistic regression analyses were performed to identify demographic, physiologic and psychological predictors of duloxetine response. Higher baseline emotional functioning predicted duloxetine response (≥30% reduction in pain; OR 4.036; 95% CI 0.999-16.308; p = 0.050). Based on the results from a multiple logistic regression using patient data from both the duloxetine and placebo treatment arms, duloxetine-treated patients with high emotional functioning are more likely to experience pain reduction (p = 0.026). In patients with painful, oxaliplatin-induced CIPN, emotional functioning may also predict duloxetine response. ClinicalTrials.gov, Identifier NCT00489411.

Treatment adherence in a lay health adviser intervention to treat tobacco dependence.

Lay health advisers (LHAs) are increasingly used to deliver tobacco dependence treatment, especially with low-socioeconomic status (SES) populations. More information is needed about treatment adherence to help interpret mixed evidence of LHA intervention effectiveness. This study examined adherence to behavioral counseling and nicotine patches in an LHA intervention with 147 Ohio Appalachian female daily smokers. Participants were randomly selected from clinics and randomized to the intervention condition of a randomized controlled trial. Overall, 75.5% of participants received all seven planned LHA visits, 29.3% used patches for >7 weeks and approximately half received high average ratings on participant responsiveness. Depressive symptoms and low nicotine dependence were associated with lower patch adherence while high poverty-to-income ratio was associated with high responsiveness. Compared with those with fewer visits, participants who received all visits were more likely to be abstinent (22.5 versus 2.8%, P=0.026) or have attempted quitting (85.0 versus 47.4%, P=0.009) at 3 months. High participant responsiveness was associated with 12-month abstinence. LHA interventions should focus on improving adherence to nicotine patches and managing depression because it is an independent risk factor for low adherence.

Oral cancer screening and dental care use among women from Ohio Appalachia.

INTRODUCTION: Residents of Appalachia may benefit from oral cancer screening given the region's higher oral and pharyngeal cancer mortality rates. The current study examined the oral cancer screening behaviors and recent dental care (since dentists perform most screening examinations) of women from Ohio Appalachia. METHODS: Women from Ohio Appalachia were surveyed for the Community Awareness Resources Education (CARE) study, which was completed in 2006. A secondary aim of the CARE baseline survey was to examine oral cancer screening and dental care use among women from this region. Outcomes included whether women (n=477; cooperation rate = 71%) had ever had an oral cancer screening examination and when their most recent dental visit had occurred. Various demographic characteristics, health behaviors and psychosocial factors were examined as potential correlates. Analyses used multivariate logistic regression. RESULTS: Most women identified tobacco-related products as risk factors for oral cancer, but 43% of women did not know an early sign of oral cancer. Only 15% of women reported ever having had an oral cancer screening examination, with approximately 80% of these women indicating that a dentist had performed their most recent examination. Women were less likely to have reported a previous examination if they were from urban areas (OR=0.33, 95% CI: 0.13-0.85) or perceived a lower locus of health control (OR=0.94, 95% CI: 0.89-0.98). Women were more likely to have reported a previous examination if they had had a dental visit within the last year (OR=2.24, 95% CI: 1.03-4.88). Only 65% of women, however, indicated a dental visit within the last year. Women were more likely to have reported a recent dental visit if they were of a high socioeconomic status (OR=2.83, 95% CI: 1.58-5.06), had private health insurance (OR=2.20, 95% CI: 1.21-3.97) or had consumed alcohol in the last month (OR=2.03, 95% CI: 1.20-3.42). CONCLUSION: Oral cancer screening was not common among women from Ohio Appalachia, with many missed opportunities having occurred at dental visits. Education programs targeting dentists and other healthcare providers (given dental providers are lacking in some areas of Ohio Appalachia) about opportunistic oral cancer screening may help to improve screening in Appalachia. These programs should include information about populations at high risk for oral cancer (eg smokers) and how screening may be especially beneficial for them. Future research is needed to examine the acceptability of such education programs to healthcare providers in the Appalachian region and to explore why screening was less common among women living in urban areas of Ohio Appalachia.

Risky behaviors among Ohio Appalachian adults.

This article describes the prevalence of risky behaviors known to be associated with increased cancer morbidity and mortality among Ohio Appalachian adults. These behaviors, or risk factors, include: 1) tobacco use; 2) energy imbalance (involving poor diet, obesity, and physical inactivity); and 3) sexual behaviors. We report current estimates of the prevalence of these behaviors among Ohio Appalachian adult residents and review social, psychological, and biological variables associated with these risky behaviors. We also present recent empirical studies that have been completed or are in progress in Ohio Appalachia. Finally, we discuss how these studies help bridge well-documented gaps in the literature.

Intervention to increase screening mammography among women 65 and older.

This paper reports the results of a practice-based intervention program to increase mammography screening among women 65 and older who receive their health care in the private sector. Forty-three primary-care practices and 2147 women in central and western North Carolina were enrolled in the study, and 1911 women completed all phases of the study. The intervention was a three-stage educational and counseling program designed to become progressively more intensive at each stage. The interventions included provider education in the form of current information on issues in mammography for older women, simply written educational materials on breast cancer and screening mailed to women, and a brief telephone counseling session for the women. While the analysis revealed no overall effect across all three stages of the intervention program, tests for interaction indicated a significant program effect for women who were 80 or older, had less than 9 years of education, were black, or had no private insurance to supplement Medicare. The results suggested that providing primary-care physicians with information on screening older women and providing the women with useful educational materials can increase participation in screening mammography among subgroups of women currently least likely to receive mammography screening.

Self-rated quality of life measures: effect of change to a low-fat, high-fiber, fruit and vegetable enriched diet.

The Polyp Prevention Trial (PPT) was a multicenter, randomized clinical trial to determine the effect of a low-fat (20% of energy from fat), high-fiber (18 g/1,000 kcal/day), high-fruit/vegetable (3.5 servings/1,000 kcal/day) eatingplan on the recurrence of large bowel adenomatous polyps. The PPT provided an opportunity to examine the impact of dietary changes on quality of life. At baseline and annuallyfor 4 years, participants in the Quality of Life Substudy of PPT completed a Quality of Life Factors (QF) Questionnaire, a modified Block-National Cancer Institute Food Frequency Questionnaire, and a Health and Lifestyle Questionnaire. The 51-item QF Questionnaire assessed changes in nine domains: taste, convenience, cost, self-care, social, health assessment, health belief health action, and life satisfaction. The analysis compared annual changes in domain scores for intervention (n = 194) and control (n = 200) participants. At Year 1, 363 (92%) completed a questionnaire, and 325 (82%) participants completed a Year 4 questionnaire. There were no statistically significant differences between treatment groups in the change from baseline to Year 1 for the convenience, cost, taste, health assessment, and life satisfaction domains. At Year 1, intervention participants rated the self-care (p < .001), health belief (p = .021), and health action (p < .001) domains significantly higher and the social domain significantly lower (p <.001) than control participants. These changes were consistent through Years 2, 3, and 4. This study

Risk factors for kidney stones in older women in the southern United States.

BACKGROUND: The occurrence of kidney stones is disproportionate in the southern region of the United States. Risk factors for the occurrence of kidney stones in this geographic area have not been reported previously. METHODS: The Women's Health Initiative (WHI) is an ongoing multicenter clinical investigation of strategies for the prevention of common causes of morbidity and mortality among postmenopausal women. A case-control ancillary study was conducted on 27,410 (white or black) women enrolled in the 9 southern WHI clinical centers. There were 1,179 cases (4.3%) of kidney stones at the baseline evaluation. Risk factors for stone formation were assessed in cases versus age- and race-matched control subjects. RESULTS: Risk factors (univariate) included low dietary potassium (2,404 versus 2,500 mg/day, P = 0.006), magnesium (243 versus 253 mg/day, P = 0.003) and oxalate (330 versus 345 mg/day, P = 0.02) intake, as well as increased body mass index (28.5 versus 27.7 kg/m2, P = 0.001) and a history of hypertension (42% versus 34%, P = 0.001). A slightly lower dietary calcium intake (683 versus 711 mg/day, P = 0.04) was noted in case subjects versus control subjects, but interpretation was confounded by the study of prevalent rather than incident cases. Supplemental calcium intake >500 mg/day was inversely associated with stone occurrence. CONCLUSION: Multivariate risk factors for the occurrence of kidney stones in postmenopausal women include a history of hypertension, a low dietary intake of magnesium, and low use of calcium supplements.

Development and implementation of novel community outreach methods in women's health issues: the National Centers of Excellence in Women's Health.

Numerous outreach efforts have been employed to educate both lay and professional communities about many medical issues. As part of our contracts with the Public Health Service, Office of Women's Health, Department of Health and Human Services, the National Centers of Excellence (CoEs) in Women's Health have been charged with creating innovative and effective methods of educating these audiences about the major issues involved in women's health. This mission is particularly critical in the arena of women's health, as women are responsible for approximately 75% of the healthcare decisions made by and for American families, and past efforts to provide them with good, evidence-based information have been fraught with difficulties ranging from financial to cultural. We report herein some of our successful novel outreach efforts. A common thread throughout this account is that among the most successful of the outreach activities are those that involve or incorporate existing community groups committed to women's health.

Colorectal cancer screening in North Carolina: associations with diabetes mellitus and demographic and health characteristics.

BACKGROUND: Diabetes mellitus (DM) may increase the risk of colorectal cancer, a leading cause of cancer death in the United States. This report examines factors associated with colorectal cancer screening, including DM status. METHODS: Data from the 1993/1995/1997 North Carolina (NC) Behavioral Risk Factor Surveillance System were analyzed to assess self-reported screening rates within guidelines for sigmoidoscopy/proctoscopy (sig/proct) and fecal occult blood test (FOBT). RESULTS: Overall, 28.6, 27.2, and 19.7% received a sig/proct, FOBT, or either test within guidelines, respectively. Screening rates varied according to some demographic variables, but not by DM status. However, DM status changed some relationships between screening and some demographic/health characteristics. CONCLUSIONS: Colorectal cancer screening in NC is similar to national rates, but certain subgroups are less likely to get screened. Persons with DM are as likely to get colorectal cancer screening, but some groups with DM (ethnic minorities, persons of low socioeconomic status) may be at high risk for not getting screened. Educational efforts to increase screening should target these groups.

Validation of virtual colonoscopy in the detection of colorectal polyps and masses: rationale for proper study design.

BACKGROUND: Colorectal cancer, the second-leading cause of cancer-related mortality, is a preventable malignancy in many cases. Despite the availability of several screening modalities, compliance with screening recommendations remains unacceptably low. Virtual colonoscopy is a novel, minimally-invasive technique with the potential to increase colorectal cancer screening rates, but its effectiveness must first be validated. Published studies comparing virtual colonoscopy to conventional colonoscopy have reported varying results. These discrepancies may be attributed to differences in bowel preparation and scanning techniques, as well as errors in endoscopic lesion measurement, endoscopic colonic segmental localization, and the ability of conventional colonoscopy to actually detect lesions. These methodological issues can affect scientific results and ultimately affect the public's perception of this emerging technique. AIM: The goal of this report is to expose existing methodological shortcomings and propose solutions incorporated in this study design. This article describes the rationale, study design, and outcome definitions of a single-center, blinded, direct comparative trial aiming at assessing the ability of virtual colonoscopy to detect colorectal polyps and masses relative to the criterion standard, conventional colonoscopy. DESIGN FEATURES: Bowel preparation was standardized using oral sodium phosphate lavage, orally administered iodinated contrast, and controlled colonic insufflation. Segmental unblinding allowed a second-look when results were discrepant and polyp matching was performed using an algorithm based on segmental localization and lesion size determination. CONCLUSIONS: This methodology could be applied to other studies assessing the accuracy of virtual colonoscopy in order to have uniformity of results.

Predictors of stage of adoption for colorectal cancer screening.

BACKGROUND: Although colorectal cancer is the third most common cancer in women, little is known about predictors of adherence to screening. METHODS: A randomly selected sample of 202 predominantly low-income and African-American women were interviewed. Knowledge of, attitudes and beliefs about, and practices related to flexible sigmoidoscopy (FS) screening were assessed. RESULTS: The majority of participants were in the precontemplation stage of adoption (56%). There were significant differences by stage of adoption for FS beliefs, FS barriers, risk of developing colorectal cancer, worry about getting colorectal cancer, and physician recommendation to get a FS. Predictors of adherence to FS guidelines were perceiving fewer barriers to getting a FS and having a physician recommend a FS. CONCLUSION: Seventy-two percent of the women in this study were nonadherent to FS screening guidelines. Psychosocial factors play an important role in screening for colorectal cancer. Ways of reducing barriers and increasing physician recommendations should be explored.

Use of an interrupted time-series design to evaluate a cancer screening program.

An alternative approach to intervention-control designs to evaluate community health education studies is to use a quasi-experimental design in which the outcomes of interest are examined over time in the intervention unit. The Forsyth County Cancer Screening Project (FoCaS) was a comprehensive clinic- and community-based education program to increase screening for cervical cancer and breast cancer among low-income women. This paper reports the use of piecewise regression accounting for potential effects of auto-correlation in the data to evaluate the effectiveness of the project in increasing mammography screening. Data for the evaluation of trends in screening consisted of all mammograms performed during the period of May 1992 through June 1995 at the Reynolds Health Center in Forsyth County, North Carolina. The results suggested that the FoCaS project was effective in increasing mammography screening among women age 40 or older in the study population. Analysis of the trends by age indicated that the program had differential effects on women age 40-49 and 50 or older. The results demonstrate that analyses of the type presented here can either complement or serve as an alternative to more traditional intervention-control analyses.

The Adolescent Sexual Activity Index (ASAI): a standardized strategy for measuring interpersonal heterosexual behaviors among youth.

This study reports on the properties of a standardized measure that is used to index the spectrum of sexual behaviors typical of adolescents. Prior work has shown sexual behaviors to be ordered and progressive. Using pre-coitus sexual behaviors that did not refer to sex organs and self-reports of sexual intercourse, a 13-item index was developed. The index was standardized with values ranging from 0.0 to 10.0. Measures were administered to 1493 female and 1073 male black and white adolescents aged 12-19 years in community settings. Analyses reveal the index to have high internal consistency and to perform as a psychometrically sound dependent variable. Because the index uses conservative language, its use may avoid the controversy common to much of the research on adolescent sexuality. The Adolescent Sexual Activity Index will provide researchers and practitioners with an interpretable tool for examining developmental patterns that precede sexual intercourse.

Receptivity of a worksite breast cancer screening education program.

A breast cancer screening education program was offered to 97 major worksites in Forsyth County, North Carolina. Worksites could design a program by choosing components that consisted of (1) brochures, (2) breast cancer education classes taught by program staff or (3) sending company nurses to be trained by program staff to then teach employees at the worksite. A total of 63 out of the original 97 companies (65%) accepted and offered a program to their employees. Worksites that chose to sponsor a program were more likely to have already sponsored breast cancer education programs at their worksites (P = 0.027) or to have a medical department (P = 0.006). The type of component selected was significantly associated with a history of sponsoring other health education programs (P < 0.001). Fourteen worksites chose the more intensive component, the training of a company nurse. More than half of the worksites that had never sponsored and had no plans to sponsor worksite breast education programs were receptive to our program (43 of 73, 59%). The majority of these sites (67%) chose the brochure. These results indicate that worksites are receptive to offering breast cancer educational programs if varying types of components can be selected.

Rural physicians' understanding of the state-of-the-art in breast, colon and rectum cancer treatment.

OBJECTIVES: This study measured the impact of an educational intervention aimed at heightening rural physicians' awareness of state-of-the-art breast and colorectal cancer therapies. METHODS: Pre- and post-intervention mailed surveys were administered to all primary-care physicians and referring physicians in the seven-county intervention region in North Carolina (NC) and a comparison region in South Carolina (SC). RESULTS: The survey revealed few significant changes in physicians' perspectives that could be attributed to the intervention. Physicians erroneously stated that lumpectomy without follow-up radiation was acceptable for treating breast cancer (55%), failed to indicate that adjuvant therapy was an accepted practice for treating Stage I breast cancer (67%), failed to acknowledge chemotherapy as experimental for Dukes' B colon cancer patients (70%), and failed to recognize a combination of surgery, chemotherapy, and radiation as a standard treatment for rectal cancer (25%). CONCLUSIONS: The low levels of awareness of National Cancer Institute guidelines were reflected in low breast-sparing surgery rates for women living in the intervention region. Stronger consensus on appropriate cancer treatments is needed throughout the medical community in order to reduce undesired variation in rural, community-based cancer care.

Community-based interventions to improve breast and cervical cancer screening: results of the Forsyth County Cancer Screening (FoCaS) Project.

The FoCaS (Forsyth County Cancer Screening) Project was one of six projects funded by the National Cancer Institute "Public Health Approaches to Breast and Cervical Cancer" initiative. The goal of this project was to improve the use of breast and cervical cancer screening among low-income, predominately African-American, women age 40 and older. Strategies implemented in the intervention city included public health clinic in-reach strategies (chart reminders, exam room prompts, in-service meetings, and patient-directed literature) and community outreach strategies (educational sessions, literature distribution, community events, media, and church programs). Baseline and follow-up data from independent cross-sectional samples in both the intervention and comparison cities were used to evaluate the effects of the intervention program. A total of 248 women were surveyed at baseline, and 302 women were surveyed 3 years later at follow-up. The proportion of women reporting regular use of mammography increased (31 to 56%; P < 0.001) in the intervention city. In the comparison city, a nonsignificant (ns) increase in mammography utilization was observed (33 to 40%; P = ns). Pap smear screening rates also improved in the intervention city (73 to 87%; P = 0.003) but declined in the comparison city (67 to 60%; P = ns). These relationships hold in multivariate models. The results suggest that a multifaceted intervention can improve screening rates in low-income populations. These results have important implications for community-based research and efforts in underserved populations.

Clinic-based interventions to promote breast and cervical cancer screening.

BACKGROUND: Breast and cervical cancer continue to claim the lives of women. Early detection modalities for these cancers are available; however, utilization rates are far from optimal. Studies have documented the motivating effect that physician recommendations have on compliance with preventive health behaviors. The goal of this study was to develop and implement strategies to improve the use of cervical and breast cancer screening among African-American women age 40 and older who resided in low-income housing communities. METHODS: Baseline surveys among clinic providers and a random sample of women in the target population indicated areas to be included in intervention material. Community health center-based strategies included educational interventions for providers and patients, follow-up interventions for abnormal screening tests, and the implementation of a computer tracking system. Pap smear and mammogram utilization rates at the health center were tracked throughout the project period to assess the effect of the clinic-based interventions. RESULTS: Both Pap smear and mammography rates increased over time. Fifteen cases of breast cancer and 1 case of invasive cervical cancer have been detected. Compliance rates for follow-up for cervical dysplasia have increased from 50 to 90%. CONCLUSIONS: These results suggest that clinic-based interventions can improve the use of breast and cervical cancer screening and follow-up among low-income women.

Development and implementation of outreach strategies for breast and cervical cancer prevention among African American women. FoCaS Project. Forsyth County Cancer Screening.

BACKGROUND: The purpose of the FoCaS (Forsyth County Cancer Screening) Project was to develop and implement strategies that would improve the beliefs, attitudes, and preventive health habits of populations typically considered hard to reach. Conventional health education methods have not produced substantial results; thus, innovative and unusual strategies are needed. METHODS: The FoCaS project implemented specific methods to reach the targeted population of African American women aged 40 and older that resides in public housing communities. Five outreach strategies were used: 1) educational classes (group setting and one-on-one sessions) on various topics that relate not to breast and cervical cancer but to women's issues in general; 2) media campaigns strategically scheduled throughout the year; 3) the inclusion of religion in educational classes and community outreach; 4) the use of information centers to distribute materials; and 5) a community-wide cancer-awareness event. RESULTS: These strategies reached women in nonthreatening environments that permitted heavy involvement and easy understanding of the importance of breast and cervical cancer screening. CONCLUSION: The effects of these strategies on promoting screening will be evaluated using data from the follow-up survey conducted during the spring of 1996.