Stephen J. Lepore - US grants

Psychoeducational support groups (PSGs), which appear to be effective in enhancing quality of life in other cancer populations, may also be beneficial to men with prostate cancer. The proposed study aims to: (1) compare the relative effects of two PSGs on quality of life outcomes in men with prostate cancer (education versus education + peer discussion versus control group); (2) test whether PSGs enhance quality of life through two proposed mediators--enhanced cognitive processing and increases in perceived personal control (self-efficacy); and (3) determine whether education + peer discussion enhances quality of life above and beyond education alone by further enhancing cognitive processing, or whether particular people (i.e., those with unmet support needs) are more likely to benefit than others from the addition of peer discussion to education. To date, there have been no solid studies on the effects of psychoeducational support groups on the quality of life of men with prostate cancer. The study team's preliminary data suggest that prostate cancer patients mainly want education about the disease and how to manage the negative side-effects of treatment. In the proposed study, 252 men treated for prostate cancer will be randomly assigned to one of three conditions: education, education plus discussion, or control group (measurement only). The investigators will convene seven groups of 12 men for each of the three conditions. intervention groups will meet once a week for six consecutive weeks. Quality of life and mediator variables (e.g., perceived control, cognitive processing) will be measured once before the interventions and again 2 weeks, 6 months, and 12 months after the interventions. Preliminary data from a survey of men with prostate cancer (n=181) and a randomized group intervention (education + discussion versus control; n=24) were used to determine the content of the interventions, to test the conceptual model, and to demonstrate the feasibility and effectiveness of running such groups for men with prostate cancer.

The American Health Foundation Cancer Center (AHFCC), an NCI- designated cancer center, and three minority serving institutions within the City University of New York (CUNY)-Brooklyn College, Hunter College, and The Graduate Center, will collaborate in the proposed 3- year planning initiative, designed to address the disparate cancer burden in minority populations, and increase the participation of minority scientists in behavioral and translational cancer research. The goal of the project is to train minority scientists, faculty, and graduate students in research, educational, and outreach approaches to cancer prevention. This goal will be accomplished through the following specific aims: 1) Establish an infrastructure for planning activities that will develop long- term collaborations between the AHFCC and CUNY; 2) Generate participation in cancer prevention and control research among CUNY minority graduate students through didactic training and mentored research experiences; 3) Train minority scientists at CUNY and AHFCC in behavioral and translational approaches to cancer prevention and control with minority populations through educational seminars, collaborative research, and professional development programs; 4) Involve minority community partners in planning education and outreach initiatives, to be implemented jointly by community members, educators from CUNY, and researchers from AHFCC; and 5) Develop systematic methods for quantitative and qualitative evaluation of aims 1-4, and making mid-course corrections. Key personnel will include scientists and faculty from the AHFCC Cancer Control and Health Promotion Program; the Brooklyn College Departments in Health and NUTRITION Sciences and Psychology; the Hunter College Programs in Urban Public Health and Community Health Education; and the Graduate Center's Doctoral Programs in Psychology; the Hunter College programs in Urban Public Health and Community Health Education; and the Graduate Center's Doctoral Programs in Psychology and Concentration in Health Psychology. Research, education, and outreach initiatives will be implemented with patient community, and school-based populations from North General Hospital in Harlem; Westchester Medical Center in Valhalla, NY; the Crozer Keystone Health System in Philadelphia; the Baptist Church community in Mount Vernon, NY; and School Districts 8 and 12 in the South Bronx and Brooklyn.

DESCRIPTION (provided by applicant): Relative to other racial and ethnic groups, African American men have a higher prevalence of cancer of the prostate (CaP), are more likely to present with disease at later stages, often have more aggressive tumors, are more likely to die from CaP, and tend to be less knowledgeable about CaP risk and the potential harms and benefits of CaP screening. There is no national consensus on screening for CaP, but practice guidelines recommend educating men, especially high-risk men, about the benefits and harms of CaP screening to support men in making informed decisions about CaP screening. The proposed study aims to: (a) evaluate the efficacy of a tailored telephone intervention in increasing knowledge and skills among African American men related to making an informed choice about CaP screening, (b) identify mediators and moderators of the intervention, and (c) explore predictors of CaP screening to understand why men decide to screen or not. The target population is African American men between the ages of 45 - 70 years old enrolled in the 1199 National Benefit Fund, the health care insurance fund for the largest health care workers union in the United States. Five hundred eligible and consenting men will receive a print brochure on the advantages and limitations of CaP screening and will then be randomized to receive either tailored-telephone CaP screening education or placebo (attention control) telephone education about diet and cancer risk. The tailored-telephone education program is designed as a decision support intervention and is based on the Ottawa Framework of medical decision-making. Main study outcomes are CaP decision variables (patient decision conflict, congruence between patient values and CaP screening decision) and communication variables (patient discusses CaP with physician and shares in CaP screening decision). Other important outcomes include knowledge about CaP and screening, perceived decision support, and perceived efficacy to communicate with physician. Data will be collected through patient interviews, physician reports, and medical chart and claims review at baseline and 6 -months post-intervention. This proposal addresses the strong need to educate African American men about CaP screening as a way of enhancing individualized, informed and shared decision making regarding CaP screening. By ensuring that the intervention components are theoretically grounded, acceptable to the target population, feasible in terms of time, practical, and allow for individualization, the proposed intervention strategy has the potential to be widely disseminated if efficacy is demonstrated.

DESCRIPTION (provided by applicant): Expressive writing is a theory-driven behavioral medicine intervention that is designed to enhance health and well-being through increased cognitive and emotional processing of traumatic events. Many studies have shown the health benefits of expressive writing in relatively healthy, non-clinical populations writing under highly controlled laboratory conditions. A few pilot studies have provided suggestive evidence of benefits of expressive writing on adjustment to cancer, but most of these studies have had less than ideal designs. The proposed study aims to: (1) Determine the feasibility of applying a brief, inexpensive expressive writing intervention to individuals recently treated for CRC; (2) Identify demographic and psychosocial factors that influence feasibility; (3) Determine the potential efficacy of expressive writing for improving a range of healthrelated quality of life outcomes (e.g., depressive symptoms, physical functioning and symptoms, social-emotional growth); and (4) Identify demographic and psychosocial factors that may influence the efficacy of the writing intervention. We will use a three-group, pre-post design, in which 183 women and men recently treated for Stage l-lll colon or rectal cancer will be randomly assigned to one of three conditions: expressive writing, control writing, or no writing. Data will be collected through structured, face-to-face interviews conducted shortly before the writing intervention and again at one and three months after the intervention. Primary outcomes include feasibility indicators (e.g., accrual and retention rates, acceptability of procedures, and adherence to writing instructions) and quality of life variables (general and cancer-specific, psychological depression, and social-emotional growth). Moderator variables include psychosocial variables (e.g., social constraints, intrusive thoughts) as well as socio-demographic and medical factors. Moderator analyses will focus on exploring who benefits from expressive writing and why. For instance, we predict that expressive writing will be most beneficial for people with CRC who: (a) have inadequate social support, or who feel constrained in discussing their cancer with others, and (b) have intrusive thoughts about their cancer, because the safe emotional expression of writing should buffer them from the negative effects of such unbidden thoughts on quality of life outcomes. Feasibility and efficacy data will be used to inform the development of a future randomized controlled trial.

DESCRIPTION (provided by applicant): Breast cancer (BC) survivors frequently use online support groups (OSGs) to help cope with their cancer, but evidence on the efficacy of OSGs for reducing psychological distress is weak. The proposed study assesses the potential efficacy (estimate effect sizes), acceptability, feasibility, and mediators of an innovative "prosocial" OSG (PRO-OSG) for distressed BC survivors. PRO-OSG provides structured helping opportunities (blogs, outreach) and coaching on how to recognize needs and give support to others in a BC OSG. The project is based on the "helper therapy principle," which emphasizes the psychological benefits of giving (vs. receiving) help. This is the first study to evaluate a prosocial intervention in the context of an OSG. In Aim 1, we propose using a randomized trial to assess the efficacy and effect sizes of PRO-OSG relative to a standard facilitated OSG (S-OSG). We will collect data from distressed BC survivors 1 month pre- and post-intervention using valid and reliable measures appropriate for the population. Intention-to-treat analyses will be used to compare the effects of the two interventions on levels of depression/anxiety symptoms (primary outcomes) and sense of purpose (secondary outcome) (n = 180;90 per group). We hypothesize that relative to S-OSG, PRO-OSG will have a lower level of symptoms and a higher level of sense of purpose post-intervention. Accuracy in parameter estimation techniques (AIPE) will be used to assess effect sizes on outcomes. In Aim 2, we will explore: (a) if the benefits of PRO-OSG on psychological symptoms are mediated by greater increases in positive affect, self-esteem, and sense of belonging among participants in the PRO-OSG versus S-OSG group;(b) if the benefit of PRO-OSG on sense of purpose is mediated by a greater increase in sense of belonging in the PRO-OSG versus S-OSG;and (c) if sense of belonging indirectly improves psychological symptoms by increasing sense of purpose. AIPE will be used to assess effect sizes on mediators. In Aim 3, we will examine acceptability (e.g., retention, satisfaction) and feasibility (e.g., amount of helping) of the PRO- OSG. The significant outcome of this project will be an innovative, theory-based OSG intervention model that maximizes reductions in psychological distress and increases sense of purpose among distressed BC survivors. The intervention is sustainable, because it can be implemented by organizations such as the Cancer Support Community, a partner on this project and the largest provider of free psychosocial support services for cancer survivors in North America. The intervention also can be adopted by other organizations, such as cancer centers, which to date have mostly offered face-to-face support groups with limited patient reach. Future directions include developing a larger-scale trial to further evaluate PRO- OSG;evaluating PRO-OSG in other cancer populations;and developing and assessing the efficacy of PRO-OSG training protocols that will enable peer leaders (vs. helping professionals) to facilitate OSGs. PUBLIC HEALTH RELEVANCE: Depression and anxiety symptoms and disorder are highly prevalent among BC survivors and often undertreated. Depression is more prevalent among BC survivors than many other cancers populations, but existing interventions are not widely acceptable, accessible, or highly effective. The proposed study will develop and evaluate an innovative "prosocial" online support group that provides structured helping opportunities (blogs, outreach) and coaching on how to recognize needs and give support to others in an online support group for distressed BC survivors.

DESCRIPTION (provided by applicant): Child secondhand smoke exposure (SHSe) is a significant, complex public health problem that is linked to cancer and cardiovascular disease risk factors, and many other health consequences including asthma, otitis, SIDS, and dental carries. With many regions adopting public smoking bans, reducing home-level smoking (homes and cars) has become the last bastion of intervention to protect children from SHSe. In addition, reducing SHSe in low-income, medically-underserved communities has become a public health priority due to the increased SHSe morbidity burden these populations bear. Given evidence that single-level approaches (e.g., home smoking bans brief provider advice) are insufficient to tackle the many facets of this multi- determined problem, this proposal will test a comprehensive, multilevel intervention in communities with the highest SHSe morbidity risks. The proposed intervention model integrates strategies across clinic, family, and community levels of service. While specific components are evidence-based, the proposed model is novel and consistent with the NIH roadmap to advance the science of behavior change by testing multilevel interventions. We propose to provide a clinic-level quality improvement (CQI) intervention based on Clinical Effort Against Secondhand Smoke Exposure (CEASE) to address child SHSe in 4 pediatric clinics in low-income Philadelphia communities. We will then randomize 466 eligible smoking parents visiting these clinics into a home-level behavioral counseling intervention (CQI+BC) based on Family Rules for Establishing Smoke-free Homes (FRESH), or a home-level attention control intervention (CQI+A). CQI+BC merges behavioral counseling (e.g., intensive skills training, support) where SHSe occurs (home/car) with navigation of community-level services to facilitate access to and effective use of no-cost nicotine withdrawal medications. Participants will complete assessments at pre-treatment, 3-month end of treatment, and 12-month follow-up. The primary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in greater reductions in child cotinine (SHSe biomarker) and reported cigarettes exposed/day. A secondary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in a higher cotinine-verified, 7-day point prevalence quit rate among parents. We also will test the hypothesis that social support, coping skills, and self-efficacy mediate effects of CQI+BC on smoking outcomes and explore whether other smokers at home, level of nicotine dependence, and depression/anxiety symptoms attenuate treatment effects. The proposed approach is likely to be more effective than existing, single-level approaches because the integrated intervention levels reinforce one another, potentially producing synergistic effects on outcomes. In addition to improving patient care, this model has high potential for dissemination and public health impact by reducing tobacco-related health and cost burdens in target populations that would benefit most from this approach. Findings from mediator and moderator aims will inform theory and future directions in this field by identifying how and for whom the intervention works. PUBLIC HEALTH RELEVANCE: Children's secondhand smoke exposure (SHSe) is a significant, multi-determined public health problem that relates to numerous diseases consequences that are magnified among young children and the medically underserved. Because the failure to develop multilevel approaches to address this complex problem remains an obstacle to progress in this field, we propose an innovative multilevel model for addressing child SHSe by integrating a pediatric clinic-level intervention (improving services to smoking parents), a home-level behavioral counseling intervention (intensive skills training), and community-level systems navigation support (facilitating access and effective use of reimbursable cessation medication.) If shown to be efficacious, the proposed intervention represents a sustainable model for SHSe reduction among underserved populations in which existing community agencies have already expressed interest.

? DESCRIPTION (provided by applicant): Children's secondhand smoke exposure (SHSe) remains a leading cause of avertible morbidity/mortality, with links to asthma, otitis, SIDS, behavior problems and risk of cancer and cardiovascular disease. Addressing SHSe is a public health priority, particularly in low-income, young children-a group with excess tobacco-related risk and burden. Community clinics (e.g., Women, Infants and Children [WIC]), can reach this population. WIC's standard practice for addressing SHSe includes minimal self-help advice to parents, an approach with inadequate efficacy. Clinical practice guidelines (AAR) recommend that practitioners Ask parents about child SHSe, Advise them about harms, and Refer smokers to intensive evidence-based treatments that address multiple determinants of smoking. Thus, we propose to test a multilevel, multimodal treatment model that combines a system-level WIC intervention following AAR guidelines with a more intensive, individual-level multimodal behavioral intervention (MBI) that integrates telephone SHSe reduction and cessation counseling with coaching on NCI's QuitPal mobile app and nicotine replacement therapy (NRT) use. We will train staff in Philadelphia WIC clinics to implement AAR with auto-fax referral to the trial. We will then randomize 372 eligible parents to receive AAR+MBI or AAR+CTL (attention control intervention). All participants will receive AAR because it is an easily adoptable, potentil standard of care in community clinics. The primary aim is to test the hypothesis that AAR+MBI compared to AAR+CTL will result in greater reductions in child cotinine (SHSe biomarker) and reported cigarettes exposed/day at 3-month end of treatment and 12-month follow-up. A secondary aim is to test the hypothesis that AAR+MBI vs. AAR+CTL will result in higher bioverified 7-day point prevalence quit rate among parents at 3- and 12-months. We will test the hypothesis that social support, urge coping skills, self-efficacy, and SHSe protective behaviors mediate effects of AAR+MBI on smoking outcomes and explore whether other residential smokers, level of nicotine dependence, depressive/anxious symptoms, weight concerns, intervention dosage, and pregnancy status moderate treatment effects. Our model balances necessary intervention intensity with feasible components (quitline, NRT, QuitPal) already available in under- served communities, thereby facilitating future dissemination. Unlike the NCI Quitline and many state services, the MBI follows best practice guidelines and does so without increasing clinic burden. It also can improve an underserved, high-risk population's access to and engagement in evidence-based treatment. This project has high impact potential: it will result in a novel, efficacious multilevel model for tackling the significant problem of child SHSe. Secondary aims results will inform science and theory by identifying how and for whom the model works. Future dismantling research can assess orthogonal and synergistic effects of intervention components.

Project Summary Unintended pregnancy (UP), defined as a mistimed or unwanted pregnancy, is a significant and prevalent public health problem, particularly among low-income women. Over one-half of all pregnancies are reported as unintended and UP has been linked to numerous adverse outcomes including depression, substance use, delayed prenatal care, and adverse child health outcomes. Correct and consistent use of effective contraception is the primary method to prevent UP. The Affordable Care Act of 2012 provides free contraception to women; however, removing financial barriers has not dramatically reduced UP and providing messages only during a clinical visit does not promote consistent use. We, and others, report that high depressive symptoms and low self-esteem are linked to inconsistent contraception use and increased risk of UP however, no interventions or messages address this barrier to contraception use. Thus, there is an urgent need to develop and evaluate interventions to decrease depressive symptoms, improve contraception use and reduce UP. Traditional cognitive behavioral therapy (CBT) is effective in reducing depressive symptoms; but limited utilization, poor response and low adherence to CBT is common. A recent meta-analysis suggests that incorporating peer-specialists in the delivery of CBT messages was most beneficial in reducing depressive symptoms and maintaining high participation rates among low-income women. This proposal will examine the feasibility and effectiveness of a 12-week peer-specialist led CBT intervention compared an observational control condition to reduce depressive symptoms, improve self-esteem and improve consistent contraceptive use to prevent UP among young sexually active women.