Reality Versus Grant Application Research "Plans".

This article describes the implementation of the American Indian mHealth Smoking Dependence Study focusing on the differences between what was written in the grant application compared to what happened in reality. The study was designed to evaluate a multicomponent intervention involving 256 participants randomly assigned to one of 15 groups. Participants received either a minimal or an intense level of four intervention components: (1) nicotine replacement therapy, (2) precessation counseling, (3) cessation counseling, and (4) mHealth text messaging. The project team met via biweekly webinars as well as one to two in-person meetings per year throughout the study. The project team openly shared progress and challenges and collaborated to find proactive solutions to address challenges as compared to what was planned in the original grant application. The project team used multiple strategies to overcome unanticipated intervention issues: (1) cell phone challenges, (2) making difficult staffing decisions, (3) survey lessons, (4) nicotine replacement therapy, (5) mHealth text messages, (6) motivational interviewing counseling sessions, and (7) use of e-cigarettes. Smoking cessation studies should be designed based on the grant plans. However, on the ground reality issues needed to be addressed to assure the scientific rigor and innovativeness of this study.

Patient navigation for American Indians undergoing cancer treatment: utilization and impact on care delivery in a regional healthcare center.

BACKGROUND: A study was undertaken to assess patient navigation utilization and its impact on treatment interruptions and clinical trial enrollment among American Indian cancer patients. METHODS: Between February 2004 and September 2009, 332 American Indian cancer patients received patient navigation services throughout cancer treatment. The patient navigation program provided culturally competent navigators to assist patients with navigating cancer therapy, obtaining medications, insurance issues, communicating with medical providers, and travel and lodging logistics. Data on utilization and trial enrollment were prospectively collected. Data for a historical control group of 70 American Indian patients who did not receive patient navigation services were used to compare treatment interruptions among those undergoing patient navigation during curative radiation therapy (subgroup of 123 patients). RESULTS: The median number of contacts with a navigator was 12 (range, 1-119). The median time spent with the navigator at first contact was 40 minutes (range, 10-250 minutes), and it was 15 minutes for subsequent contacts. Patients treated with radiation therapy with curative intent who underwent patient navigation had fewer days of treatment interruption (mean, 1.7 days; 95% confidence interval [CI], 1.1-2.2 days) than historical controls who did not receive patient navigation services (mean, 4.9 days; 95% CI, 2.9-6.9 days). Of the 332 patients, 72 (22%; 95% CI, 17%-26%) were enrolled on a clinical treatment trial or cancer control protocol. CONCLUSIONS: Patient navigation was associated with fewer treatment interruptions and relatively high rates of clinical trial enrollment among American Indian cancer patients compared with national reports.

Intention to receive cancer screening in Native Americans from the Northern Plains.

BACKGROUND: Native Americans are disproportionately affected by cancer morbidity and mortality. This study examined intention to receive cancer screening in a large sample of Native Americans from the Northern Plains, a region with high cancer mortality rates. METHODS: A survey was administered orally to 975 individuals in 2004-2006 from three reservations and among the urban Native American community in the service region of the Rapid City Regional Hospital. Data analysis was conducted in 2009. RESULTS: About 63% of the sample planned to receive cancer screening. In multivariate analyses, individuals who planned to receive cancer screening were women, responsible for four or more people, received physical examinations at least yearly and had received prior cancer screening. They also were more likely to hold the belief that most people would go through cancer treatment even though these treatments can be emotionally or physically uncomfortable. About 90% of those who did not plan to receive cancer screening would be more likely to intend to receive cancer screening if additional resources were available. CONCLUSIONS: In an area of high cancer morbidity and mortality, over one-third of screening eligible individuals did not plan to receive cancer screening. Future research should evaluate the potential for improving cancer screening rates through interventions that seek to facilitate increased knowledge about cancer screening and access to cancer screening services in the community.

Community-based participatory development, implementation, and evaluation of a cancer screening educational intervention among American Indians in the Northern Plains.

The study describes the creation and implementation of a culturally appropriate cancer education intervention, and assesses its efficacy among American Indians in a community with documented cancer-related disparities. Education workshops were developed and conducted on three western South Dakota reservations and in Rapid City by trained community representatives. Over 400 individuals participated in the 2-h workshops. Participants answered demographic questions, questions about previous cancer screening (to establish baseline screening rates), and completed a pre- and post-workshop quiz to assess learning. Participants demonstrated significant increases in cancer screening-related knowledge levels. Surveys reveal that participants found the information of high quality, great value and would recommend the program to friends. Pre-workshop data reveals cancer screening rates well below the national average. Workshop participants increased their knowledge about cancer etiology and screening. This intervention may represent an effective tool for increasing cancer screening utilization among American Indians.

Patterns of cigarette smoking initiation in two culturally distinct American Indian tribes.

OBJECTIVES: To better understand patterns of initiation among American Indians we examined age-related patterns of smoking initiation during adolescence and young adulthood in 2 American Indian tribes. METHODS: We used log-rank comparison and a Cox proportional hazard regression model to analyze data from a population-based study of Southwest and Northern Plains American Indians aged 18 to 95 years who initiated smoking by age 18 years or younger. RESULTS: The cumulative incidence of smoking initiation was much higher among the Northern Plains Indians (47%) than among the Southwest Indians (28%; P < .01). In the Southwest, men were more likely than women to initiate smoking at a younger age (P < .01); there was no such difference in the Northern Plains sample. Northern Plains men and women in more recent birth cohorts initiated smoking at an earlier age than did those born in older birth cohorts. Southwest men and women differed in the pattern of smoking initiation across birth cohorts as evidenced by the significant test for interaction (P = .01). CONCLUSION: Our findings underscore the need to implement tobacco prevention and control measures within American Indian communities.

Walking forward: a program designed to lower cancer mortality rates among American Indians in western South Dakota.

Walking Forward is a community-based participatory research program in western South Dakota funded by the National Cancer Institute (NCI). The primary goal of this initiative is to address the high and ominously increasing cancer mortality rates among American Indians by facilitating access to innovative clinical trials, behavioral and genetic research and tailored patient navigation. The critical outcomes include: an unprecedented accrual rate of 25 percent in clinical trials, including cancer treatment and cancer control trials; a significant reduction in the number of missed treatment days among navigated American Indian cancer patients undergoing radiation therapy; and most importantly, establishment of trusting partnerships with the American Indian communities as reflected in enrollment in a genetic study involving the ataxia telangiectasia mutated gene. The results indicate that the Walking Forward approach presents an effective strategy to overcome the barriers to cancer care in this underserved community.

A randomized trial to reduce smoking among American Indians in South Dakota: The walking forward study.

BACKGROUND: Lung cancer is an important public health issue, particularly among American Indians (AIs). The reported decline in tobacco use for most racial/ethnic groups is not observed among AIs. This project was designed to address the research question, "Why don't more Northern Plains American Indians alter tobacco use behaviors known to increase the risk of cancer?" METHODS: Guided by the Theory of Planned Behavior, a multi-component intervention study was implemented. Adult AIs, age 18 years or older and currently smoking, were enrolled. Eligible subjects were randomized to one of 15 groups and exposed to either a MINIMAL or an INTENSE level of 4 intervention components. The intervention was delivered face-to-face or via telephone by Patient Navigators (PN). The primary outcome was self-reported abstinence from smoking verified by carbon monoxide measurement. RESULTS: At 18 months post-quit date, 88% of those who were still in the study were abstinent. This included 6% of all participants who enrolled in the study (14/254) and 13% of those who made it to the quit date (14/108). No intervention groups were found to have significant proportions of participants who were abstinent from smoking at the quit date (visit 5) or primary outcome visit (18 months post-quit date, visit 11), but use of pharmacologic support for abstinence was found to be an effective strategy for individuals who continued participation throughout the study. Those who remained in the study received more visits and were more likely to be abstinent. CONCLUSIONS: Use of NRT increased the odds of not smoking, as assessed at the 18-month follow-up visit, but no other interventions were found to significantly contribute to abstinence from smoking. Although the intervention protocol included numerous points of contact between CRRs and participants (11 visits) loss to follow-up was extensive with only 16/254 remaining enrolled. Additional research is needed to improve understanding of factors that influence enrollment and retention in smoking cessation interventions for AI and other populations.

Prevalence of ATM Sequence Variants in Northern Plains American Indian Cancer Patients.

PURPOSE: To identify sequence variants of the ataxia telangiectasia mutated (ATM) gene and establish their prevalence rate among American Indian (AI) as compared with non-AI cancer patients. MATERIALS AND METHODS: DNA was isolated from blood samples collected from 100 AI and 100 non-AI cancer patients undergoing radiation therapy, and a blinded assessment of the ATM sequence was conducted. Quantitative PCR assessment of copy number for each exon was also performed. The main outcome measure was the prevalence of ATM variants in the two patient populations. RESULTS: No statistically significant differences for total prevalence of ATM variants among AI and non-AI patients were found. Of the 25 variants identified, 5 variants had a prevalence of >2%, of which 4 occurred at a rate of >5% in one or both groups. The prevalence of these four variants could meaningfully be compared between the two groups. The only statistically significant difference among the groups was the c.4138C > T variant which is predicted not to affect protein function, seen in 8% of AI versus 0% of non-AI patients (P = 0.007). No exonic copy number changes were found in these patients. CONCLUSION: This study is the first to determine the prevalence of ATM variants in AIs.

Toward an mHealth Intervention for Smoking Cessation.

The prevalence of tobacco dependence in the United States (US) remains alarming. Invariably, smoke-related health problems are the leading preventable causes of death in the US. Research has shown that a culturally tailored cessation counseling program can help reduce smoking and other tobacco usage. In this paper, we present a mobile health (mHealth) solution that leverages the Short Message Service (SMS) or text messaging feature of mobile devices to motivate behavior change among tobacco users. Our approach implements the Theory of Planned Behavior (TPB) and a phase-based framework. We make contributions to improving previous mHealth intervention approaches by delivering personalized and evidence-based motivational SMS messages to participants. Our proposed solution implements machine learning algorithms that take the participant's demographic profile and previous smoking behavior into account. We discuss our preliminary evaluation of the system against a couple of pseudo-scenarios and our observation of the system's performance.

Cancer screening in Native Americans from the Northern Plains.

BACKGROUND: Native Americans from the Northern Plains have the highest age-adjusted cancer mortality compared to Native Americans from any other region in the U.S. PURPOSE: This study examined the utilization and determinants of cancer screening in a large sample of Native Americans from the Northern Plains. METHODS: A survey was administered orally to 975 individuals in 2004-2006 from three reservations and among the urban Native-American community in the service region of the Rapid City Regional Hospital. Data analysis was conducted in 2007-2008. RESULTS: Forty-four percent of individuals reported ever receiving any cancer screening. Particularly low levels were found for breast, cervical, prostate, and colon cancer screening. In multivariate analyses, the strongest determinant of receiving cancer screening overall or cancer screening for a specific cancer site was recommendation for screening by a doctor or nurse. Other determinants associated with increased likelihood of ever having cancer screening included older age, female gender, and receiving physical exams more than once a year. Increased age was a determinant of breast cancer screening, and receiving physical exams was associated with cervical cancer screening. CONCLUSIONS: Cancer screening was markedly underutilized in this sample of Native Americans from the Northern Plains. Future research should evaluate the potential for improving cancer screening.