A Descriptive Survey Study of Patient Needs and Preferences for Cancer Pain Self-Management Support.

OBJECTIVES: To characterize the needs and preferences for pain self-management support (SMS) among patients with cancer during the transition of cancer care from the hospital to the home setting. SAMPLE & SETTING: 38 participants with cancer pain at a research-intensive cancer center in New England. METHODS & VARIABLES: A descriptive, cross-sectional survey study was conducted to investigate relationships among preferred and received support, extent and management of transitional change, and pain outcomes. Pain intensity and interference were measured using the Brief Pain Inventory-Short Form, transitional change was measured using the Measurement of Transitions in Cancer Scale, and SMS was measured using dichotomous questions. RESULTS: About half of participants reported concordance between preferred and received cancer pain SMS in the hospital and at home. The extent of transitional change in cancer care was found to be a significant predictor of average pain intensity in the hospital and pain interference at home. Satisfaction with cancer pain SMS was a significant predictor of pain intensity at home. IMPLICATIONS FOR NURSING: The extent of change during care transitions should be considered when fulfilling patient needs and preferences for cancer pain SMS to optimize outcomes.

Perceptions of clinical support for employed breast cancer survivors managing work and health challenges.

PURPOSE: A substantial portion of breast cancer survivors are active in the workforce, yet factors that allow survivors to balance work with cancer management and to return to work are poorly understood. We examined breast cancer survivors' most valued/desired types of support in early survivorship. METHODS: Seventy-six employed breast cancer survivors answered an open-ended survey question assessing the most valued/desired support to receive from healthcare providers during early survivorship to manage work and health. Cutrona's (Journal of Social and Clinical Psychology 9:3-14, 1990) optimal matching theory and House's (1981) conceptualization of social support types informed our analyses. Data were content-analyzed to identify themes related to support, whether needed support was received or not, and the types of healthcare providers who provided support. RESULTS: We identified six themes related to types of support. Informational support was valued and mostly received by survivors, but they expected more guidance related to work. Emotional support was valued but lacking, attributed mainly to providers' lack of personal connection and mental health support. Instrumental (practical) support was valued but received by a small number of participants. Quality of life support to promote well-being and functionality was valued and often received. Other themes included non-specific support and non-support. CONCLUSIONS: This study expands our understanding of how breast cancer survivors perceive work-related support from healthcare professionals. Findings will inform targeted interventions designed to improve the support provided by healthcare professionals. IMPLICATIONS FOR CANCER SURVIVORS: Breast cancer survivors managing work and health challenges may benefit by having their unmet support needs fulfilled.

Exercise for Smoking Cessation in Postmenopausal Women: A Randomized, Controlled Trial.

BACKGROUND: Postmenopausal smokers have difficulty quitting smoking and experience considerable weight gain with smoking cessation. We examined whether adjunctive smoking treatment with exercise, compared to a relaxation control condition, could improve cigarette abstinence, decrease cigarettes smoked per day (CPD), and ameliorate changes in body mass index (BMI) in postmenopausal smokers. METHODS: Women (N = 301) signed informed consent and were randomized to treatment at two sites (Universities of Connecticut and Minnesota). We randomized groups of participants to a comprehensive group treatment program that included 12 weeks of varenicline and either a moderate exercise or relaxation component for 6 months. Participants were followed for a year after medication treatment. RESULTS: Overall, 17.3% of patients reported carbon monoxide-verified continuous abstinence for the 9- to 12-week period, and 11.6% reported prolonged abstinence at 1 year, with no significant differences between treatment conditions. CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment. The Exercise condition reported smoking fewer CPD over time, and that advantage widened over time. In terms of BMI, significant effects for time in weeks, and for the interaction of Week × Treatment condition, reflected gradually increasing BMI in these women over time, but with the increase in BMI slower in the Exercise condition. CONCLUSIONS: Exercise, compared to relaxation, was associated with a reduced BMI and CPD in postmenopausal women, but did not increase end of treatment or prolonged abstinence. Further research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women. IMPLICATIONS: This study adds to the literature on the effectiveness of a moderate exercise intervention compared to a relaxation control condition as an adjunctive treatment for smoking cessation in postmenopausal women. Our exercise program did not increase end of treatment or prolonged abstinence rates in postmenopausal women; however, there was a beneficial effect on smoking reduction and reduced body mass index. Additional research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.

Opioid Use and Rate of Nicotine Metabolism Among Pregnant Smokers.

INTRODUCTION: Smokers who use opioids smoke more cigarettes per day (CPD) than non-opioid users, which could be due to the effects of opioids on nicotine metabolism. Moreover, nicotine metabolism increases during pregnancy, potentially making quitting more difficult for pregnant smokers. We examined nicotine metabolism and its association with opioid use (OU) and CPD in pregnant smokers. METHODS: We recruited pregnant women who smoked at least 5 CPD for a clinical trial of smoking cessation. Plasma nicotine metabolite ratio (NMR; trans-3'-hydroxycotinine (3HC)/cotinine)-a biomarker of nicotine metabolism-OU (involving methadone, buprenorphine, fentanyl, oxycodone, or tramadol), and CPD were assessed at baseline. We used linear regression to examine the associations between log-transformed NMR, OU, and CPD, adjusting for race/ethnicity and menthol smoking. RESULTS: Among 129 pregnant smokers, 25 (19%) were opioid users; most were maintained on methadone (n = 14). Compared to non-OU smokers, OU smokers had higher median CPD (10.0 vs. 7.0, p = .0007), serum 3HC (81.0 vs. 42.0 ng/mL, p = .0001), and NMR (0.63 vs. 0.43, p < .0001). In addition, methadone-maintained smokers had a higher median NMR than non-OU smokers (0.66 vs. 0.43, p = .0004). Adjusting for covariates, log-transformed NMR was greater in OU smokers (p = .012), specifically methadone-maintained smokers (p = .024), than non-OU smokers. CONCLUSIONS: Our preliminary results show that OU is associated with a higher NMR in pregnant smokers. A larger study sample is needed to replicate this finding, examine potential mechanisms, and determine its clinical significance. IMPLICATIONS: Among pregnant smokers, we observed that nicotine metabolism was significantly faster among opioid users-the majority of whom were on methadone maintenance-compared to nonusers, which could have implications for smoking cessation. Further studies are needed to replicate this finding, evaluate potential mechanisms, and determine its clinical significance.

Randomized Trial of Nicotine Inhaler for Pregnant Smokers.

Background: Smoking during pregnancy is a serious public health problem in need of better treatments. Nicotine replacement treatment (NRT) (patch or gum) has not been shown in randomized placebo-controlled trials to be efficacious for smoking cessation during pregnancy. However, the nicotine inhaler may have advantages over other NRTs as it replicates some of the sensory effects of smoking. Objective: The purpose of the study was examine the efficacy and safety of the nicotine inhaler for smoking cessation during pregnancy. We hypothesized that the nicotine inhaler compared to placebo would increase quit rates and reduce smoking during treatment and at the end of pregnancy, result in a higher birth weight and gestational age in the offspring, and reduce the incidence of preterm birth and low birth weight infants. Study Design: We conducted a randomized, double-blind, placebo-controlled trial of the nicotine inhaler for smoking cessation during pregnancy. Pregnant women who smoked ≥5 cigarettes daily received behavioral counseling and random assignment to a 6-week treatment with nicotine or placebo inhaler, followed by a 6-week taper period. Throughout treatment, we assessed tobacco exposure biomarkers, cessation rates, and adverse events. We also obtained information on birth outcomes. The primary outcome was smoking cessation at 32-34 weeks gestation; secondary outcomes were smoking reduction, birth weight and gestational age, and the incidence of preterm birth or low birth weight infants. We compared treatment groups on these measures using t-tests, Fisher's exact tests, and multivariate linear and logistic regression. Results: Participants in the placebo (n=67) and nicotine (n=70) groups were comparable on baseline characteristics, though women in the placebo group reported a higher motivation to quit (p=0.016). Biochemically-validated smoking cessation rates were similar with nicotine and placebo (after 6 weeks of treatment: 4% (3/70) vs. 3% (2/67), respectively, p< 0.99, and at 32-34 weeks gestation: 10% (7/70) vs. 18% (12/67), respectively, p=0.220). Cigarettes per day (CPD) decreased over time in both groups (p< 0.001), with the nicotine inhaler group having a greater decrease than the placebo group two (p=0.022) and six weeks after the quit date (p=0.042), but not at 32-34 weeks gestation (p=0.108). Serum cotinine levels, birth weight, gestational age and reductions in carbon monoxide did not differ by group. However, the incidence of preterm delivery was higher in the placebo than the nicotine group: 15% (10/67) vs. 4% (3/67), respectively, p=0.030). The incidence of delivering a low birth weight infant was also higher in the placebo than the nicotine group: 15% (10/67) vs. 6% (4/67), respectively, p=0.035, but not after adjusting for preterm delivery p=0.268. Conclusions: Although the nicotine inhaler group did not have a higher quit rate during pregnancy than the placebo group, the outcome of preterm delivery occurred less frequently in the nicotine group.

Study protocol for a telephone-based smoking cessation randomized controlled trial in the lung cancer screening setting: The lung screening, tobacco, and health trial.

Lung cancer mortality can be reduced by 20% via low dose CT lung cancer screening (LCS) and treatment of early-stage disease. Providing tobacco use treatment to high risk cigarette smokers in the LCS setting may result in health benefits beyond the impact of LCS. As one of the nine trials in the National Cancer Institute's Smoking Cessation at Lung Examination (SCALE) collaboration, the goal of the Lung Screening, Tobacco, and Health (LSTH) trial is to develop a scalable and cost-effective cessation intervention for subsequent implementation by LCS programs. Guided by the RE-AIM Framework, the LSTH trial is a two-arm RCT (N = 1330) enrolling English- and Spanish-speaking smokers registered for LCS at one of seven collaborating sites. Participants are randomly assigned to Usual Care (UC; three proactive telephone counseling sessions/two weeks of nicotine patches) vs. Intensive Telephone Counseling (ITC; eight proactive sessions/eight weeks of nicotine patches, plus discussion of the LCS results to increase motivation to quit). Telephone counseling is provided by tobacco treatment specialists. To increase continuity of care, referring physicians are notified of participant enrollment and smoking status following the intervention. Outcomes include: 1) self-reported 7-day, 30-day, and sustained abstinence, and biochemically-verified at 3-, 6-, and 12-months post-randomization, 2) reach and engagement of the interventions, and 3) cost-effectiveness of the interventions. The Cancer Intervention and Surveillance Modeling Network (CISNET) will model long-term impacts of six SCALE trials on the cost per life year saved, quality-adjusted life years saved, lung cancer mortality reduction, and population mortality. CLINICAL TRIALS REGISTRATION: The trial is registered at clinical trials.gov: NCT03200236.

Living with heart despite recurrent challenges: Psychological care for adults with advanced cardiac disease.

The number of people living with advanced heart disease is increasing rapidly as a result of improvements in cardiac treatments, better long-term survival from primary cardiac events, and the increase in the demographic of Americans over the age of 65. Successful living with advanced heart disease now often means patients must manage recurrent challenges to health and function from hospitalizations, exacerbations of illness, and cardiac procedures. Depression, anxiety and strain on intimate relationships are familiar problems for people with advanced heart disease that often go untreated. Though these problems have been studied in populations with acute coronary syndrome, there has been less attention focused on people in later stages of cardiac disease progression. Innovative psychological approaches are needed to address the emotional and behavioral challenges for patients coping with heart failure, implantable cardioverter defibrillators, ventricular assist devices, and heart transplant. This article describes common psychological difficulties for adults living with advanced heart disease and potential psychological targets for intervention. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Incorporating Multiple Perspectives Into the Development of an Electronic Survivorship Platform for Head and Neck Cancer.

PURPOSE: To improve the care of survivors of head and neck cancer, we developed the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR). HN-STAR is an electronic platform that incorporates patient-reported outcomes into a clinical decision support tool for use at a survivorship visit. Selections in the clinical decision support tool automatically populate a survivorship care plan (SCP). We aimed to refine HN-STAR by eliciting and incorporating feedback on its ease of use and usefulness. METHODS: Human-computer interaction (HCI) experts reviewed HN-STAR using think-aloud testing and the Nielsen Heuristic Checklist. Nurse practitioners (NPs) thought aloud while reviewing the clinical decision support tool and SCP and responded to an interview. Survivors used HN-STAR as part of a routine visit and were interviewed afterward. We analyzed themes from the feedback. We described how we addressed each theme to improve the usability of HN-STAR. RESULTS: Five HCI experts, 10 NPs, and 10 cancer survivors provided complementary usability insight that we categorized into themes of improvements. For ease of use, themes included technical design considerations to enhance user interface, ease of completion of a self-assessment, streamlining text, disruption of the clinic visit, and threshold for symptoms to appear on the SCP. The theme addressing usefulness was efficiency and comprehensiveness of the clinic visit. For each theme, we report revisions to HN-STAR in response to the feedback. CONCLUSION: HCI experts provided key technical design insights into HN-STAR, whereas NPs and survivors provided usability feedback and clinical perspectives. We incorporated the feedback into the preparation for additional testing of HN-STAR. This method can inform and improve the ease of use and usefulness of the survivorship applications.

Correlates of Electronic Cigarettes Use Before and During Pregnancy.

INTRODUCTION: Electronic cigarette use is rapidly gaining in popularity. However, little is known about correlates and reasons for electronic cigarette use by women of reproductive age, a group for which the safety and efficacy of electronic cigarette use is of particular interest. METHODS: As part of a clinical trial for smoking cessation, we surveyed pregnant smokers about their lifetime use of electronic cigarettes, previous use of any adjunctive treatments for smoking cessation, and use of electronic cigarettes during pregnancy. We examined associations between electronic cigarette use and participant characteristics. RESULTS: Fifty-three percent (55/103) of participants had previously tried electronic cigarettes. Ever users smoked more cigarettes per day before pregnancy (p = .049), had a greater number of previous quit attempts (p = .033), and were more likely to identify as being Hispanic or non-Hispanic white than never users (p = .027). Fifteen percent of participants (15/103) reported previous use of electronic cigarettes for smoking cessation, which was more common than the use of any specific FDA-approved smoking cessation medication. Fourteen percent of participants (14/103) reported electronic cigarette use during pregnancy, most commonly to quit smoking. A history of substance abuse (p = .043) and more previous quit attempts (p = .018) were associated with electronic cigarette use during pregnancy. CONCLUSIONS: Use of electronic cigarettes to quit smoking may be common in women of reproductive age, including those who are pregnant. More research is needed to determine the risks and benefits of electronic cigarette use in this population of smokers. IMPLICATIONS: This study shows that electronic cigarettes are used by women of reproductive age, including pregnant smokers. The implications of this finding are that there is an urgent need to examine the risks and benefits of electronic cigarette use, especially by pregnant women. The study also shows that electronic cigarettes are commonly used as a smoking cessation aid in women of reproductive age. The greater likelihood of electronic cigarette use compared to proven adjunctive smoking treatments suggests that electronic cigarettes should be examined as a potential aid to cessation in this population.

Influence of Baseline Psychological Health on Muscle Pain During Atorvastatin Treatment.

BACKGROUND: 3-hydroxy-3-methylglutaryl coenzyme A reductase reductase inhibitors (statins) are generally well tolerated, with statin-associated muscle symptoms (SAMS) the most common side effect (~10%) seen in statin users. However, studies and clinical observations indicate that many of the self-reported SAMS appear to be nonspecific (ie, potentially not attributable to statins). OBJECTIVE: Mental health and well-being influence self-perception of pain, so we sought to assess the effect of baseline well-being and depression on the development of muscle pain with 6 months of atorvastatin 80 mg/d (ATORVA) or placebo in healthy, statin-naive adults. METHODS: The Psychological General Well-being Index (n = 83) and Beck Depression Inventory (n = 55) questionnaires were administered at baseline in participants (aged 59.5 ± 1.2 years) from the effect of Statins on Skeletal Muscle Function and Performance (STOMP) trial (NCT00609063). Muscle pain (Short-Form McGill Pain Questionnaire [SF-MPQ]), pain that interferes with daily life (Brief Pain Inventory [BPI]), and pain severity (BPI) were then measured before, throughout, and after treatment. RESULTS: At baseline, there were no differences in well-being (Psychological General Well-being Index), depression (Beck Depression Inventory), or pain measures (SF-MPQ and BPI) (P values ≥ .05) between the placebo and ATORVA groups. Baseline well-being correlated negatively with baseline BPI pain severity (r = -0.290, P = .008). Baseline depression correlated with baseline pain (SF-MPQ; r = 0.314, P = .020). Baseline well-being and depression did not predict the change in pain severity or interference after 6 months among the total sample or between groups (P values ≥ .05). CONCLUSION: Baseline well-being and depression were not significant predictors of pain after 6 months of ATORVA (P values ≥ .05). Thus, they do not appear to increase the risk of SAMS in otherwise healthy adults.

A head and neck cancer intervention for use in survivorship clinics: a protocol for a feasibility study.

BACKGROUND: Head and neck cancer survivors commonly experience severe long-term toxicities, late-occurring symptoms, and significant risks of the second primary malignancy and comorbid illnesses. With multiple simultaneous health issues, these complex cancer survivors often do not receive comprehensive health care that addresses their needs. A tool is needed to streamline and standardize comprehensive care for this cohort. METHODS/DESIGN: We designed the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR) to address health care challenges for head and neck cancer survivors. HN-STAR is an electronic platform that aims to simplify the provision of personalized care in cancer survivorship clinics. It uses an algorithmic approach to integrate patient-reported outcomes, clinical details, and evidence-based guidelines to standardize comprehensive care provided in routine survivorship visits. It has four integrated components: (1) a simplified treatment summary, which pulls treatment details from a clinical database or can be completed manually using a streamlined form; (2) an online self-assessment for patients to report their own symptoms; (3) an interactive discussion guide presenting all relevant information to the provider during the clinic visit; and (4) a survivorship care plan generated at the end of each visit that reflects decisions made during the visit. By using a modifiable electronic platform, HN-STAR provides a method for incorporating survivorship care plans into clinical practice and for disseminating evidence on symptom management and preventive care. This is a study to assess the feasibility of a future multi-site, randomized clinical trial of HN-STAR. We will enroll head and neck cancer survivors who are followed in one of two nurse practitioner-led survivorship clinics. We will implement HN-STAR for one routine survivorship visits. We will assess (1) usability and feasibility outcomes of HN-STAR from the perspective of key stakeholders and (2) the planned outcomes intended for the larger trial. We will collect usability and feasibility data from online surveys of survivors and their providers. Our findings will inform whether it is feasible to advance HN-STAR to trial. If so, we will adapt HN-STAR and the study design of the trial in response to feedback from survivors and providers. The long-term goal is to determine if such an intervention will lead to improved and simplified comprehensive survivorship care. DISCUSSION: This feasibility study will evaluate implementation of HN-STAR into clinical practice in terms of usability, practicality, and clinical flow in two distinct clinical settings. This study will also provide critical baseline data to characterize this vulnerable population. Findings from this study will inform a multicenter randomized trial of HN-STAR, aimed at standardizing and streamlining the delivery of evidence-guided comprehensive care for head and neck cancer survivors. Ultimately, if found effective, the modular structure of HN-STAR could permit its expansion to survivors of other complex cancers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02571673.

A randomized controlled trial of two mail-based lifestyle interventions for breast cancer survivors.

PURPOSE: Although breast cancer survivors' lifestyle choices affect their subsequent health, a majority do not engage in healthy behaviors. Because treatment end is a "teachable moment" for potentially altering lifestyle change for breast cancer survivors, we developed and tested two mail-based interventions for women who recently completed primary treatment. METHODS: One hundred seventy-three survivors were randomly assigned to (1) Targeting the Teachable Moment (TTMI, n = 57), (2) Standard Lifestyle Management (SLM, n = 58), or (3) usual care (UC, n = 58) control group. Participants who were assigned to TTMI and SLM received relevant treatment materials biweekly for 4 months. Participants were assessed at baseline (T1, before randomization), post-treatment (T2, 4 months), and follow-up (T3, 7 months). Fruit and vegetable (F/V) intake, fat intake, and moderate-to-vigorous physical activity (MVPA) were assessed. RESULTS: Results showed promise for these mail-based interventions for changes in health behaviors: Survivors in TTMI (+.47) and SLM (+.45) reported increased F/V intake, whereas those in UC (-.1) reported decreased F/V intake from T1 to T2. Changes in minutes of MVPA from T1 to T2 were higher in SLM than UC and marginally higher in TTMI than UC. However, these differences were due to decreased MVPA in UC rather than increased MVPA in the intervention groups. There were no group differences regarding fat intake. Survivors reported high satisfaction and preference for mail-based interventions, supporting feasibility. CONCLUSIONS: Mail-based lifestyle interventions for breast cancer survivors may benefit F/V intake and physical activity. Further testing and optimizing of these interventions is warranted.

The impact of tetrahydrobiopterin administration on endothelial function before and after smoking cessation in chronic smokers.

Cardiovascular disease mortality is reduced following smoking cessation but the reversibility of specific atherogenic risk factors such as endothelial dysfunction is less established. We assessed brachial artery flow-mediated dilation (FMD) in 57 chronic smokers and 15 healthy controls, alone and after oral tetrahydrobiopterin (BH4) administration, to assess the extent to which reduced bioactivity of BH4, a cofactor for the endothelial nitric oxide synthase enzyme (eNOS), contributes to smoking-associated reductions in FMD. Thirty-four smokers then ceased cigarette and nicotine use for 1 week, after which FMD (±BH4 administration) was repeated. Brachial artery FMD was calculated as the peak dilatory response observed relative to baseline (%FMD). Endothelium-independent dilation was assessed by measuring the dilatory response to sublingual nitroglycerin (%NTG). Chronic smokers exhibited reduced %FMD relative to controls: (5.6±3.0% vs. 8.1±3.7%; P<0.01) and %NTG was not different between groups (P=0.22). BH4 administration improved FMD in both groups (P=0.03) independent of smoking status (P=0.78) such that FMD was still lower in smokers relative to controls (6.6±3.3% vs. 9.8±3.2%; P<0.01). With smoking cessation, FMD increased significantly (from 5.0±2.9 to 7.8±3.2%;P<0.01); %NTG was not different (P=0.57) and BH4 administration did not further improve FMD (P=0.33). These findings suggest that the blunted FMD observed in chronic smokers, likely due at least in part to reduced BH4 bioactivity and eNOS uncoupling, can be restored with smoking cessation. Post-cessation BH4 administration does not further improve endothelial function in chronic smokers, unlike the effect observed in nonsmokers, indicating a longer-term impact of chronic smoking on vascular function that is not acutely reversible.

Genetic Vulnerability to Menthol Cigarette Preference in Women.

BACKGROUND: Smokers may prefer menthol cigarettes to mask the bitter taste of nicotine. Variation in the taste receptor gene, TAS2R38, may contribute to preference for menthol cigarettes. AIMS: To determine whether two common haplotypes of TAS2R38 (proline-alanine-valine [PAV] and alanine-valine-isoleucine [AVI]), which have been associated, respectively, with bitter taste or a lack of bitter taste produced by propylthiouracil, are associated with preference for menthol cigarettes. METHODS: Data on smoking and blood for DNA extraction and genotyping were obtained from 323 pregnant non-Hispanic or Hispanic Caucasian smokers. We genotyped three TAS2R38 single nucleotide polymorphisms (rs713598, rs1726866, and rs10246939) and constructed haplotypes. We examined associations between menthol preference and the frequency and distribution of the AVI and PAV haplotypes among study participants. RESULTS: Participants smoked an average of 16 cigarettes per day before pregnancy. The PAV and AVI haplotype frequencies were 48% and 45%, respectively. Non-Hispanic women were less likely than Hispanic women to smoke menthol cigarettes. As hypothesized, the frequency of the PAV haplotype was greater in menthol than non-menthol smokers in both non-Hispanics (54% vs. 30%; χ(2) = 13.04, P < .001) and Hispanics (53% vs. 25%; χ(2) = 5.77, P = .016). This effect persisted after controlling for potential confounders in multivariate logistic regression. Menthol smokers had a greater number of PAV haplotypes/individual than non-menthol smokers [non-Hispanics odds ratio (OR) = 3.02 (1.56-5.85); P = .001; Hispanics OR = 3.60 (1.23-10.56); P = .020]. CONCLUSIONS: These preliminary data support the hypothesis that a genetic propensity to experience heightened bitter taste perception increases the preference for menthol cigarettes.

Predictive validity of the attitudes toward medical help-seeking scale.

OBJECTIVE: This study examines the predictive validity of the action/intention subscale of the attitudes toward seeking medical help scale in a college sample. PARTICIPANTS: Participants were 51 female undergraduates recruited from psychology classes. Data were collected at two time points between January and April, 2011. METHODS: Students completed the attitudes subscale and a measure of medical contacts twice, over a two month interval. RESULTS: Internal consistency and test-retest reliability of the measure were supported. Correlations between time one attitudes and medical contacts/intentions at time two provide evidence for predictive validity of the measure. CONCLUSION: This relatively brief, psychometrically sound measure of attitudes toward medical help seeking can be used to identify individuals who may be reluctant to seek health care and to assess the effectiveness of health education programs.

Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS vanguard randomized controlled trial.

IMPORTANCE: Controversy remains about whether depression can be successfully managed after acute coronary syndrome (ACS) and the costs and benefits of doing so. OBJECTIVE: To determine the effects of providing post-ACS depression care on depressive symptoms and health care costs. DESIGN: Multicenter randomized controlled trial. SETTING: Patients were recruited from 2 private and 5 academic ambulatory centers across the United States. PARTICIPANTS: A total of 150 patients with elevated depressive symptoms (Beck Depression Inventory [BDI] score ≥10) 2 to 6 months after an ACS, recruited between March 18, 2010, and January 9, 2012. INTERVENTIONS: Patients were randomized to 6 months of centralized depression care (patient preference for problem-solving treatment given via telephone or the Internet, pharmacotherapy, both, or neither), stepped every 6 to 8 weeks (active treatment group; n = 73), or to locally determined depression care after physician notification about the patient's depressive symptoms (usual care group; n = 77). MAIN OUTCOME MEASURES: Change in depressive symptoms during 6 months and total health care costs. RESULTS: Depressive symptoms decreased significantly more in the active treatment group than in the usual care group (differential change between groups, -3.5 BDI points; 95% CI, -6.1 to -0.7; P = .01). Although mental health care estimated costs were higher for active treatment than for usual care, overall health care estimated costs were not significantly different (difference adjusting for confounding, -$325; 95% CI, -$2639 to $1989; P = .78). CONCLUSIONS: For patients with post-ACS depression, active treatment had a substantial beneficial effect on depressive symptoms. This kind of depression care is feasible, effective, and may be cost-neutral within 6 months; therefore, it should be tested in a large phase 3 pragmatic trial. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01032018.

Major depression and PTSD in pregnant smokers enrolled in nicotine gum treatment trial.

BACKGROUND AND OBJECTIVES: Pregnant women face considerable barriers to smoking cessation. The purpose of this study was to determine the prevalence of major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) and response to smoking cessation treatment in pregnant smokers participating in a randomized, placebo-controlled trial of nicotine gum. METHODS: Participants were 194 low-income, ethnically diverse pregnant smokers. RESULTS: Utilizing a structured interview, 45% and 18% of the subjects met criteria for a lifetime diagnosis of MDD and PTSD, respectively. There was no difference in response to treatment, based on the presence of either of these psychiatric disorders. CONCLUSIONS: Cumulatively, these findings provide evidence of the high degree of unmet mental health needs in pregnant smokers. SCIENTIFIC SIGNIFICANCE: Pregnant women with a history of MDD and PTSD appear to be as likely to benefit from smoking cessation treatment as those without such a history.

Is religious coping related to better quality of life following acute myocardial infarction?

Although few studies have examined the extent to which religiousness is related to better well-being following acute myocardial infarction (AMI), studies from the broader literature suggest that positive religious coping may be helpful while more negative forms of religious coping may be related to poorer well-being. To assess the relationship between positive and negative religious coping and depressive symptoms in patients with AMI, we collected data twice over a 1-month period from 56 patients hospitalized with a first AMI. Controlling for demographic variables and social support, both positive and negative religious coping were independently related to higher levels of depressive symptoms both in hospital and at a one-month follow-up. Further, even when controlling for baseline depressive symptoms, religious coping predicted higher subsequent depressive symptoms. These results suggest that religious coping appears to be maladaptive in dealing with acute MI, perhaps because this type of recovery requires more active forms of coping.

Rationale and design of a randomized clinical trial comparing stress reduction treatment to usual cardiac care: the Reducing Vulnerability to Implantable Cardioverter Defibrillator Shock-Treated Ventricular Arrhythmias (RISTA) trial.

OBJECTIVE: To present the design of a multicenter, randomized trial testing the effects of stress reduction treatment (SRT) on the prevalence of shock-treated ventricular arrhythmias among patients with an implantable cardioverter defibrillator (ICD). Significant adjustment problems secondary to ICD shock can increase the likelihood of arrhythmias requiring shock for termination. Whether SRT can reduce arrhythmias requiring shock for termination in patients with ICDs has not been tested in clinical trials. METHODS: New ICD recipients and previous recipients who have received an appropriate therapeutic shock in the last 6 months (n = 304) will be enrolled and randomized to either SRT or usual cardiac care. Participants complete a psychosocial questionnaire and undergo laboratory mental stress testing and 24-hour Holter monitoring with diary at study entry and approximately 4 months later. Follow-ups are completed at 6, 12, and 24 months post randomization to assess occurrence of ICD shock for ventricular arrhythmias (primary outcome), antitachycardia pacing events, medication changes, hospitalizations, deaths, and quality of life. RESULTS: Log-rank test and Cox proportional hazards model will be used to test the effects of SRT on time to first shock-treated ventricular arrhythmia, with exploratory analyses testing the effects on overall frequency of ventricular arrhythmia. Secondary analyses will test the effects of SRT on laboratory stress-induced and 24-hour arrhythmogenic electrophysiological indices from pre to post treatment, and both quality of life and measures of anger across the 2 years of the study. CONCLUSIONS: The Reducing Vulnerability to ICD Shock-Treated Ventricular Arrhythmias (RISTA) Trial is the first large-scale, randomized, clinical trial designed to evaluate the effect of SRT on the prevalence of shock-treated arrhythmias among patients with an ICD. Results may demonstrate a treatment that can reduce vulnerability to arrhythmia-provoked shock and improve quality of life.

Nicotine gum for pregnant smokers: a randomized controlled trial.

OBJECTIVE: To estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy. METHODS: Pregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throughout the study. RESULTS: Participants in the nicotine (n = 100) and placebo (n = 94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotine gum compared with placebo (after 6 weeks of treatment: 13% compared with 9.6%, P=.45; at 32-34 weeks of gestation: 18% compared with 14.9%, P=.56). Using a completer analysis, nicotine gum significantly reduced the number of cigarettes smoked per day (nicotine gum: -5.7 [standard deviation (SD)=6.0]; placebo: -3.5 [SD=5.7], P=.035), and cotinine concentration (nicotine gum: -249 ng/mL [SD=397]; placebo: -112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotine gum compared with placebo (3,287 g [SD=566] and 2,950 g [SD=653], respectively, P<.001). Gestational age was also greater with nicotine-replacement therapy than with placebo (38.9 weeks [SD=1.7] and 38.0 weeks [SD=3.3], respectively; P=.014). CONCLUSION: Although nicotine gum did not increase quit rates, use of nicotine gum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing.