A Multicenter Randomized Controlled Trial of Intensive Group Therapy for Tobacco Treatment in HIV-Infected Cigarette Smokers.

BACKGROUND: Tobacco use has emerged as the leading killer of persons living with HIV (PLWH) in the United States. Little is known about the efficacy of tobacco treatment strategies in PLWH. DESIGN: Randomized controlled trial comparing Positively Smoke Free (PSF), an intensive group therapy intervention targeting HIV-infected smokers, to brief advice to quit. All participants were offered a 12-week supply of nicotine patches. METHODS: A cohort of 450 PLWH smokers, recruited from HIV-care centers in the Bronx, New York, and Washington, DC, were randomized 1:1 into the PSF or brief advice to quit conditions. PSF is an 8-session program tailored to address the needs and concerns of HIV-infected smokers and delivered by a trained smoking cessation counselor and PLWH ex-smoker peer pair. The primary outcome was biochemically confirmed, 7-day point-prevalence abstinence at 6 months. RESULTS: In the intention to treat analysis, PSF condition subjects had nearly double the quit rate of controls, 13% vs. 6.6% [odds ratio = 2.10 (95% confidence interval = 1.10 to 4.14), P = 0.04], at 3 months, but no significant difference in abstinence was observed at 6 months. PSF participants exhibited lower nicotine dependence and higher self-efficacy to resist smoking temptations at both 3 and 6 months compared with controls. Lower educational attainment, current cocaine use, past use of nicotine patches, and higher distress tolerance were significant predictors of continued smoking at 6 months. CONCLUSIONS: These findings suggest a role for group therapy among tobacco treatments for PLWH smokers, but strategies to augment the durability of early effects are needed.

Gender Differences among Smokers Living with HIV.

Tobacco use has emerged as a leading cause of death among persons living with HIV (PLWH) who smoke cigarettes. In contrast to the general population where smoking prevalence in men exceeds that in women, large surveys have shown similar smoking rates among male and female PLWH. There are important behavioral and biological differences between male and female smokers, but little is known about the relationships between tobacco use and gender in PLWH. Herein, the authors present a detailed examination of gender differences in smokers living with HIV (N = 267; 54% male, 46% female) recruited in 2 tobacco treatment trials. The authors found higher rates of heavy smoking and other substance use in men. Women were more likely to have used pharmacotherapy during quit attempts. Asthma rates were markedly higher in female smokers. There were no significant differences in a range of psychobehavioral domains or in cessation rates between male and female smokers living with HIV.

Loneliness in HIV-infected smokers.

Loneliness is common in persons living with HIV (PLWH). Lonely people smoke at higher rates than the general population, and loneliness is a likely contributor to the ongoing smoking epidemic among PLWH. We explored factors associated with loneliness in a cohort of 272 PLWH smokers enrolled in two separate tobacco treatment trials. Loneliness was independently associated with lack of a spouse or partner, lower educational attainment, "other or unknown" HIV exposure category, depression, anxiety, recent alcohol consumption, and higher daily cigarette consumption. Referral to group therapy reduced loneliness, whereas referral to an individual web-based tobacco treatment did not.

Self-efficacy to quit in HIV-infected smokers.

INTRODUCTION: Tobacco use is epidemic among persons living with HIV (PLWH), and several studies have shown self-efficacy (SE) to be a predictor of successful cessation. This study examined sociobehavioral correlates of SE and its predictive value for successful cessation in a group of PLWH smokers. METHODS: The study was conducted on combined patient data from 2 separate randomized controlled trials of tobacco treatment for PLWH smokers. Both trials utilized the same SE scale at the same timepoints, and both had the same smoking cessation endpoint (biochemically confirmed, 7-day, point prevalence abstinence at 3 months). Univariate and multivariate techniques were used to analyze the merged dataset. RESULTS: Baseline SE data were available for 272 subjects. The Self-Efficacy/Temptations Scale-Long Form demonstrated good internal reliability with overall and subscale Cronbach's alpha of .77-.92. Younger age, HIV risk other than injection drug use, recent alcohol use, and higher scores for anxiety, depression, loneliness, and nicotine dependence were all significantly correlated with lower baseline SE. Posttreatment SE was significantly predictive of successful cessation, whereas baseline SE was not. Subjects randomized to the treatment interventions were significantly more likely to quit (AOR = 2.99 [1.26-7.01], p = .01), and logistic regression suggested a possible mediating effect of posttreatment SE. CONCLUSIONS: SE is tightly correlated with a number of modifiable affective and behavioral factors in PLWH smokers, and measures aimed at increasing the SE to abstain in such individuals may enhance the effect of targeted tobacco treatment strategies.

Chronic myeloid leukemia (CML): association of treatment satisfaction, negative medication experience and treatment restrictions with health outcomes, from the patient's perspective.

BACKGROUND: The availability of the tyrosine-kinase inhibitor (TKI), imatinib, and later introduction of second generation TKIs, dasatinib and nilotinib, have not only improved clinical outcomes of patients with chronic myeloid leukemia (CML), but also provide multiple therapeutic options for CML patients. Despite the widespread use of these oral therapies, little is known about the impact of different treatment regimens on patient-reported outcomes (PROs) among CML patients. The objective of this study was to assess the impact of patient-reported treatment restrictions and negative medication experiences (NMEs) on satisfaction and other health outcomes among patients with CML treated with oral TKIs. METHODS: Participants recruited from survey panels and patient networks in the United States (US) and Europe completed an online questionnaire. Respondents included adults (≥ 18 years) with chronic-phase CML currently on TKI treatment. Study variables included treatment difficulty (i.e., difficulty in following treatment regimens), CML dietary/dosing requirements, NMEs, and validated PROs assessing treatment satisfaction, health-related quality of life (HRQoL), activity impairment, and non-adherence. Structural equation models assessed associations among variables, controlling for covariates. RESULTS: 303 patients with CML (US n=152; Europe n=151; mean age 51.5 years; 46.2% male) completed the questionnaire. Approximately 30% of patients reported treatment difficulties; treatment difficulty was higher among nilotinib (63.3%) than among dasatinib (2.6%) or imatinib (19.2%) treated patients (p<0.0001). Non-adherence was generally low; however, patients on nilotinib vs. imatinib reported missing doses more often (p<0.05). Treatment satisfaction was associated with significantly increased HRQoL (p<0.05) and lower activity impairment (p<0.01). NMEs were associated with decreased treatment satisfaction (p<0.01) and HRQoL (p<0.05), and greater activity impairment (p<0.01). Higher overall treatment restrictions were associated with greater treatment difficulty (p<0.001), which correlated with non-adherence (p<0.01). CONCLUSIONS: Treatment satisfaction and NMEs are important factors associated with HRQoL among patients with CML. Increased treatment restrictions and associated difficulty may affect adherence with TKIs. Choosing a CML treatment regimen that is simple and conveniently adaptable in patients' normal routine can be an important determinant of HRQoL and adherence.

A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers.

BACKGROUND: More than half of the persons living with human immunodeficiency virus (HIV; PLWH) in the US smoke cigarettes, and tobacco use is responsible for considerable morbidity and mortality in this group. Little is known about the efficacy of tobacco treatment strategies in PLWH. DESIGN: Randomized controlled trial comparing Positively Smoke Free (PSF), an intensive group-therapy intervention targeting HIV-infected smokers, to standard care. METHODS: A cohort of 145 PLWH smokers, recruited from an HIV-care center in the Bronx, New York, were randomized 1:1 into the PSF program or standard care. All were offered a 3-month supply of nicotine replacement therapy. PSF is an 8-session program tailored to address the needs and concerns of HIV-infected smokers. The sessions were cofacilitated by a graduate student and an HIV-infected peer. The primary outcome was biochemically confirmed, 7-day point-prevalence abstinence at 3 months. RESULTS: In the intention-to-treat analysis, PSF condition subjects had nearly double the quit rate of controls (19.2% vs. 9.7%, P = 0.11). In the complete case, as-treated analysis, assignment to PSF was associated with increased odds of quitting (odds ratio(adj) 3.55, 95% confidence interval 1.04 to 12.0). Latino ethnicity and lower loneliness score were predictive of abstinence. The subjects in the PSF condition exhibited significant decreases in daily cigarette consumption and significant increases in self-efficacy and in motivation to quit. Attendance of ≥7 sessions was associated with higher quit rates. CONCLUSIONS: These findings suggest a positive effect of PSF on cessation rates in PLWH smokers. Loneliness and self-efficacy are influential factors in the smoking behaviors of PLWH.

Cigarette smoking behaviors and beliefs in persons living with HIV/AIDS.

OBJECTIVE: To measure biopsychosocial domains related to tobacco use in persons living with HIV/AIDS (PLWHAs). METHODS: Cross-sectional interview study of 60 PLWHA smokers randomly selected from an HIV clinic. RESULTS: Participants averaged 14.4 cigarettes daily. Sixty-five percent were moderately or highly nicotine dependent, and most were motivated to quit. Substance use and depression were very common. Most reported that smoking helped them cope with depression, anxiety, and anger. Twenty-seven percent thought (mistakenly) that smoking raised their T-cell counts and/or helped fight infections. Referrals to quitlines or cessation programs were uncommon. CONCLUSIONS: Smoking among PLWHAs is a challenging problem requiring targeted intervention strategies.

Provider beliefs and practices relating to tobacco use in patients living with HIV/AIDS: a national survey.

The entire online HIV Medical Association US registry was invited to complete a questionnaire regarding beliefs and practices related to smoking in persons living with HIV/AIDS (PLWHAs). 363/486 returned completed questionnaires. Respondents from 43 states reported caring for 76,570 PLWHAs. Only 22.9% had ever received formal tobacco treatment training. Respondents generally agreed that smoking is an important issue in PLWHAs, but reported low levels of cessation-promoting activities. Providers with larger patient panels, "primarily HIV" practices, and formal cessation training had higher questionnaire scores, indicating stronger beliefs in the harms of smoking, benefits of quitting, and effectiveness of cessation strategies.

Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life.

PURPOSE: This study examines the impact of yoga, including physical poses, breathing, and meditation exercises, on quality of life (QOL), fatigue, distressed mood, and spiritual well-being among a multiethnic sample of breast cancer patients. PATIENTS AND METHODS: One hundred twenty-eight patients (42% African American, 31% Hispanic) recruited from an urban cancer center were randomly assigned (2:1 ratio) to a 12-week yoga intervention (n = 84) or a 12-week waitlist control group (n = 44). Changes in QOL (eg, Functional Assessment of Cancer Therapy) from before random assignment (T1) to the 3-month follow-up (T3) were examined; predictors of adherence were also assessed. Nearly half of all patients were receiving medical treatment. RESULTS: Regression analyses indicated that the control group had a greater decrease in social well-being compared with the intervention group after controlling for baseline social well-being and covariates (P < .0001). Secondary analyses of 71 patients not receiving chemotherapy during the intervention period indicated favorable outcomes for the intervention group compared with the control group in overall QOL (P < .008), emotional well-being (P < .015), social well-being (P < .004), spiritual well-being (P < .009), and distressed mood (P < .031). Sixty-nine percent of intervention participants attended classes (mean number of classes attended by active class participants = 7.00 +/- 3.80), with lower adherence associated with increased fatigue (P < .001), radiotherapy (P < .0001), younger age (P < .008), and no antiestrogen therapy (P < .02). CONCLUSION: Despite limited adherence, this intent-to-treat analysis suggests that yoga is associated with beneficial effects on social functioning among a medically diverse sample of breast cancer survivors. Among patients not receiving chemotherapy, yoga appears to enhance emotional well-being and mood and may serve to buffer deterioration in both overall and specific domains of QOL.

Urban voices: the quality-of-life experience among women of color with breast cancer.

OBJECTIVES: Research on the health-related quality of life (HRQL) among women of color (i.e., Hispanics and African Americans) with breast cancer suggests that they may be at elevated risk for a variety of physical and psychosocial sequelae. The context in which these women perceive, experience, and respond to these HRQL challenges can provide important information for planning a culturally appropriate palliative care treatment plan. METHODS: In an effort to understand the quality of life experience after breast cancer among women of color, this study describes the nature and impact of physical, emotional, and menopausal symptoms among African American (n = 8) and Hispanic (n = 12) breast cancer survivors based on qualitative data gathered through semistructured interviews. Themes were identified and categorized into six HRQL domains: physical (e.g., pain, nausea), psychological (e.g., sadness, irritability), cognitive (e.g., memory problems), sexual (e.g., decreased desire), social/functional (e.g., financial strain, social distress), and spiritual/existential (e.g., increased faith, spiritual coping), with high interrater reliability (kappa = .81). RESULTS: For both groups, physical issues had a major impact on HRQL, with psychological issues being additionally salient for Hispanic women. Most (88%) African American women voiced positive changes in their faith after diagnosis whereas 50% of Hispanic women viewed faith as an important way of coping with breast cancer. SIGNIFICANCE OF RESULTS: This research broadens our understanding of the experience of breast cancer among ethnic minority women, and in turn, offers some key directions for guiding the development of culturally tailored HRQL interventions.

Psychosocial needs assessment among an underserved, ethnically diverse cancer patient population.

Little attention has been directed towards identifying and addressing the psychosocial needs of ethnic minority and underserved cancer patients. This study describes the development of a psychosocial needs survey and patterns and predictors of need among an ethnically diverse underserved cancer patient population in Bronx, New York. A 34-item psychosocial needs assessment survey was developed to assess 4 categories of need: Informational, Practical, Supportive, and Spiritual. A total of 248 oncology outpatients (48% non-Hispanic whites, 25% African Americans; 19% Hispanic) completed the survey in oncology clinic waiting rooms. The survey demonstrated high internal consistency and face validity. Ethnicity was the sole predictor of needs (P < .02), even after controlling for education, time since diagnosis, treatment status, marital status, and age. The mean percentage of needs endorsed by African Americans, Hispanics, and non-Hispanic whites respectively was 81%, 85%, 70% for Informational; 63%, 68%, 36% for Practical; 69%, 73%, 48% for Supportive; and 49%, 60%, 31% for Spiritual needs. This needs assessment offers clear directions in which to focus QOL intervention efforts among underserved and ethnic minority cancer patients. Cancer 2007. (c) 2006 American Cancer Society.

Cancer education for home health care workers: a process evaluation.

BACKGROUND: In this article, we evaluate adoption of cancer education into the mandatory in-service training of home health attendants (HHA) comprised predominantly of African American and Hispanic women. METHODS: Three home health care training agencies in Bronx, NY, incorporated cancer prevention and outreach education into HHA training. RESULTS: Across 3 years, 87% (n = 2513) of HHAs received the intervention and disseminated it to 1600 clients/family/friends. HHAs reported high program satisfaction (98%) and interest (82%) in cancer outreach. Agency staff reported more benefits than costs to implementation. CONCLUSIONS: The home health care training agency appears an accessible and effective bridge for disseminating cancer education to the underserved.

Development of a new instrument for rheumatoid arthritis: the Cedars-Sinai Health-Related Quality of Life instrument (CSHQ-RA).

OBJECTIVE: To update and complement existing instruments, we developed a multidimensional disease-specific instrument, intended to reflect the impact of rheumatoid arthritis (RA) with modern treatment options on patient's Health-Related Quality of Life (HRQOL). METHODS: Items were developed from a systematic review of published HRQOL measures and transcripts of RA patient focus groups. Items were refined by an expert panel and administered to 350 patients for psychometric testing. RESULTS: The systematic review identified 228 potential items, and the focus group transcripts identified 96 additional items. Expert review and pilot testing resulted in an initial 58-item instrument. Twenty-six items were excluded due to floor/ceiling effects, poor response rates, or high item-item correlations. Factor analysis identified a 5-factor structure (eigenvalues >or=1). Multi-trait scaling performed on both completed surveys confirmed the 5 sub-scale structure (Cronbach's > 0.87). CONCLUSION: The CSHQ-RA consists of 33 items that address 5 HRQOL domains, each with high internal consistency. Additional testing will assess the instrument's validity and responsiveness.