IMPORTANCE Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care.OBJECTIVE To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking. DESIGN, SETTING, AND PARTICIPANTSThis unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018.INTERVENTIONS Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline). MAIN OUTCOME AND MEASURESThe primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates. RESULTS Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2). CONCLUSIONS AND RELEVANCE Among smokers recently diagnosed with cancer in 2 NationalCancer Institute-designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research.
Most patients are not able to achieve recommended levels of physical activity following an acute coronary syndrome (ACS). Existing interventions to promote activity have not focused on promoting psychological well-being, which is independently linked to superior cardiac health. To address this gap, we developed and tested a combined positive psychology-motivational interviewing (PP-MI) intervention in post-ACS patients to assess its feasibility and explore potential benefits in an initial randomized trial. We compared a 12-week, phone-delivered, PPMI intervention to an attention-matched, MI-based health education control condition among 47 post-ACS patients with low baseline health behavior adherence. Feasibility/acceptability were assessed via rates of session completion and participant session ratings; we also explored between-group differences in positive affect, other self-reported outcomes, and accelerometer-measured physical activity, via mixed effects regression models, at 12 and 24 weeks. PP-MI participants completed a mean of 10.0 (SD 2.2) sessions (84%), and mean participant ratings of sessions' ease/utility were >8/10, above a priori thresholds for success. Compared to the control condition, PP-MI was associated with greater improvements in positive affect at 12 and 24 weeks (12 weeks: estimated
Healthy eating is key to successful management of type 2 diabetes (T2D). As discussed in this narrative review, there are strong indications that spousal support is an important element affecting dietary adherence in T2D. To provide a synthesized review of this evidence, Google Scholar and PubMed were searched, 28 relevant studies were selected, and the results were narratively summarized. A framework for information synthesis was developed which categorized results into three major themes: how gender roles and spousal dynamics function in spousal support for dietary adherence, the role of race and ethnicity in the influence of spousal support on dietary adherence, and the extant interventional work specifically targeting spousal support for T2D. The reviewed studies indicate that gender role performance is the principal factor in the relationship between spousal support and dietary adherence in T2D, though race and ethnicity also contribute. Despite this evidence, interventions that specifically target spousal support to improve dietary adherence in T2D have had limited efficacy. A better understanding of the relationship between spousal support and dietary adherence, as well as a subsequent utilization of this information to create targeted and effective interventions, would be of great benefit to the field of diabetes management.
Background Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. Methods/Design A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30 days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6 months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. Discussion This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients.
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