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.

Validation of self-reported breast and cervical cancer screening tests among low-income minority women.

The objective of the Forsyth County Cancer Screening Project is to assess barriers to breast and cervical cancer screening among low-income women and to develop an educational program to address these barriers. To properly assess the barriers, it was first necessary to determine if self-reported rates of breast and cervical cancer screening were accurate. All women who participated in the baseline survey (n = 555) were asked to provide information regarding if, where, and when they had obtained mammograms and Pap smears. Identified health care facilities were then contacted to verify this information. Approximately 80% of responses were verified for at least one of the exams with the information provided. For mammography, 77% of self-reports were correct, whereas 67% of self-reports of Pap smear screening were correct (kappa = 0.54 and 0.15, respectively). For both tests, women thought they had received them more recently than they actually had, by an average of 3 months for mammography and 23 months for Pap smears. Using validated reports of screening did not substantially change identified predictors of screening for mammography. For Pap smear screening, however, most of the identified predictors of screening became nonsignificant when medical chart reports were used instead of self-reports, suggesting that caution should be used in relying on self-reports to design programs to improve cervical cancer screening practices.

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.

Improving compliance among women with abnormal Papanicolaou smears.

OBJECTIVE: To determine whether a clinic-based intervention, consisting of motivational brochures and a tracking system, increases adherence to recommendations for treatment in women with abnormal Papanicolaou smears. METHODS: Three pairs of clinics--two family planning clinics, two family practice clinics, and two dysplasia clinics--were randomized within pairs either to provide the intervention or to maintain usual contact procedures with women having abnormal Papanicolaou smears. Baseline adherence rates were assessed through chart review during 3 randomly selected months of the previous year. Intervention clinics received the tracking system and motivational brochures, which were sent to women on notification of their cervical abnormalities. Comparison clinics also used the tracking system but did not include the brochures when notifying women of their abnormalities. Adherence rates were assessed prospectively for approximately 100 consecutive nonpregnant women with abnormal Papanicolaou smears (inflammatory benign atypia, or cervical intraepithelial neoplasia I, II, or III) at each clinic. RESULTS: Within clinics, baseline adherence rates ranged from 34-69% for atypia and 33-88% for dysplasia. For dysplasia patients, the overall analysis indicated a significant increase in adherence for the intervention clinics (P = .03); however, for atypia patients, the observed difference was not statistically significant (P = .23). Extensive analyses of the data from family planning clinics indicated that women receiving the intervention were more likely to obtain follow-up treatment (odds ratio [OR] 2.6, 95% confidence interval 1.15-5.85). There was a suggestion that the intervention could have a greater effect among African-American women (OR 15.7) compared with white women (OR 1.8) (P = .09). White women, those with dysplasia, nonsmokers, and nulliparas were most likely to adhere to treatment recommendations. CONCLUSION: A motivational brochure can enhance adherence to treatment recommendations among women with abnormal Papanicolaou smears. Future studies should focus on techniques for enhancing adherence among more resistant participants.

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.

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.

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.

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.

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.

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.

Improving follow-up after an abnormal Pap smear: a randomized controlled trial.

Less than 60% of women diagnosed with cervical abnormalities on Pap smears return for proper surveillance and timely treatment. Previous tactics used to motivate these women to return have mainly relied on costly intensive recall efforts. Using a framework based on psychological value expectancy theory, a pamphlet was designed to motivate women with abnormal Pap smears to return for a repeat Pap smear. The effect of this pamphlet was tested in a randomized controlled trial. A total of 161 women with abnormal Pap smears were randomized and received either the pamphlet plus a notification letter or the letter only. The compliance rate was 64.2% in the intervention group and 51.3% in the comparison group (P = 0.10; two-tailed). In addition, subgroups of women who do not practice health-related behaviors were identified as groups where more intensive interventions may be needed. These results have implications for future strategies used to recall women with abnormal Pap smears.

Compliance behavior in women with abnormal Pap smears. Developing and testing a decision model.

This study investigated the reasons why women choose whether or not to seek treatment after being notified about an abnormal Pap smear in a women's clinic in Seattle. A hierarchic weighted utility model was developed from in-depth open-ended interviews with women who had an abnormal Pap smear and was used to identify beliefs and values related to the decision to seek treatment, i.e., a repeat Pap smear, for an abnormal Pap smear. Interviews with 18 women who had an abnormal Pap smear produced 12 issues pertinent to the behavior in question. These issues were grouped to form the hierarchy, and the decision model was then administered to 44 additional women. The model accurately classified the compliance behavior of 68% of study subjects. Moreover, the model differentiated persons who sought treatment for an abnormal Pap smear along several important dimensions: 1) doctor's opinion; 2) the accuracy or seriousness of the Pap smear result; 3) the importance of early detection; 4) familiarity with the treatment procedure; 5) time hassles (i.e., difficulties) involved in getting further treatment; 6) femininity concerns; 7) fear of cancer; and 8) perceived risk of cancer. These dimensions suggest specific content areas that may be used to develop low-cost compliance intervention strategies for use in clinical settings.

Breast cancer screening education in the workplace.

This study examined the use of breast cancer screening education programs in 102 of the major workplaces in Forsyth County, North Carolina. Characteristics of workplaces that had sponsored such programs within the preceding three years were identified. Eighteen percent of the workplaces surveyed had offered breast cancer screening education programs. Factors that were directly related to having sponsored a program included the size of the workforce, the number of female employees, and the proportion of female employees over 40 years old. Characteristics related to health service activities in the workplace were also predictive. Neither the type of industry nor the insurance status of the workplace was significantly related to having sponsored a program.

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.

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.