Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0].

BACKGROUND: Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet an evidence-based tobacco use intervention has not been well-integrated into cancer care in community oncology settings. This paper describes the protocol of a nation-wide clinical trial conducted by the ECOG-ACRIN National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base to assess the effectiveness of a virtual tobacco treatment intervention and the process of implementing tobacco treatment in NCORP community oncology settings. METHODS/DESIGN: This two-arm, multisite (n: 49 NCORP sites) hybrid type 1 effectiveness-implementation randomized controlled trial compares the effectiveness of a Virtual Intervention Treatment (VIT) versus an Enhanced Usual Control (EUC) among English and Spanish speaking patients recently diagnosed with cancer, reporting current smoking and receiving care at a participating NCORP Community or Minority/Underserved Site. The VIT includes up to 11 virtual counseling sessions with a tobacco treatment specialist and up to 12 weeks of nicotine replacement therapy (NRT). The EUC arm receives a referral to the NCI Quitline. The primary study outcome is biochemically confirmed 7-day point prevalence smoking abstinence. Moderators of treatment effect will be assessed. The study evaluates implementation processes from participating NCORP site staff via survey, administrative, and focus group data, including reach, acceptability, appropriateness, fidelity, feasibility, adoption, cost and sustainability outcomes. DISCUSSION: This trial will generate findings about the effectiveness of an evidence-based virtual tobacco treatment intervention targeting patients diagnosed with cancer and illuminate barriers and facilitators that influence implementing tobacco treatment into community oncology settings nationally. In the era of COVID-19, virtual care solutions are vital for maximizing access and utilization of tobacco treatment delivery. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03808818) on January 18th, 2019; Last update posted: May 21st, 2020.

Quality of life in dental hygienists using complementary alternative medicine approaches for work-related musculoskeletal disorders.

OBJECTIVES: The use of conventional treatment for work-related musculoskeletal disorders (WRMSDs) reduces the prevalence of pain, but with popularity of complementary alternative medicine (CAM) therapies for treatment, it is important to explore their use and impact on dental hygienists (DHs) quality of life (QoL). METHODS: A cross-sectional survey research design was used with a non-probability sample of dental hygienists (n = 85) with WRMSDs who used CAM therapies. The WHOQOL-BREF was used to assess quality of life and compared with CAM use and frequency. Analysis included descriptive, t-tests, correlation and chi-square tests of independence. RESULTS: The most commonly used CAM types were massage (81%) and chiropractic manipulation (67%) with 66% of respondents using two or more CAM therapies. Participants using five or less different CAMs (n = 46), compared with those using more than five CAM types (n = 35, M = 2.3, SD = 1.5), t (79) = 2.7, p = 0.01, had a higher average number of years before they noticed their WRMSD (M = 3.3, SD = 1.9). Participants reporting use of a higher number of CAM types also had lower QoL physical health domain scores (rho = -0.2, p = 0.03). CONCLUSIONS: Dental hygienists used a variety of CAM approaches to manage WRMSDs and had a lower QoL across all domains (physical health, psychological health, social relationships and environment) than the normative mean. More research is needed to explore the use of CAM approaches, such as yoga, for prevention and management of WRMSDs to improve QoL.

Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial.

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 Participants: This 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 Measures: The 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 National Cancer 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. Trial Registration: ClinicalTrials.gov Identifier: NCT01871506.

Usefulness of a Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity After an Acute Coronary Syndrome.

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, PP-MI 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 through 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, through mixed effects regression models, at 12 and 24 weeks. PP-MI participants completed a mean of 10.0 (standard deviation 2.2) sessions (84%), and mean participant ratings of sessions' ease/utility were >8/10, above a priori thresholds for success. Compared with the control condition, PP-MI was associated with greater improvements in positive affect at 12 and 24 weeks (12 weeks: estimated mean difference [EMD] = 3.90 [SE = 1.95], p = 0.045, effect size [ES] = 0.56; 24 weeks: EMD = 7.34 [SE = 2.16], p <0.001, ES = 1.12). PP-MI was also associated with more daily steps at 12 weeks (EMD = 1842.1 steps/day [SE = 849.8], p = 0.030, ES = 0.76) and greater moderate-vigorous activity at 24 weeks (EMD = 15.1 minutes/day [SE = 6.8], p = 0.026, ES = 0.81). In conclusion, PP-MI was feasible in post-ACS patients and showed promising effects on well-being and physical activity; additional studies are needed to confirm these findings.

The role of spousal support for dietary adherence among type 2 diabetes patients: a narrative review.

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.

Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial.

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 30days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6months. 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.

Teacher-led relaxation response curriculum in an urban high school: impact on student behavioral health and classroom environment.

CONTEXT: Recent data suggest that severe stress during the adolescent period is becoming a problem of epidemic proportions. Elicitation of the relaxation response (RR) has been shown to be effective in treating anxiety, reducing stress, and increasing positive health behaviors. OBJECTIVE: The research team's objective was to assess the impact of an RR-based curriculum, led by teachers, on the psychological status and health management behaviors of high-school students and to determine whether a train-the-trainer model would be feasible in a high-school setting. DESIGN: The research team designed a pilot study. SETTING: The setting was a Horace Mann charter school within Boston's public school system. PARTICIPANTS: Participants were teachers and students at the charter school. INTERVENTION: The team taught teachers a curriculum that included (1) relaxation strategies, such as breathing and imagery; (2) psychoeducation regarding mind-body pathways; and (3) positive psychology. Teachers implemented this curriculum with students. OUTCOME MEASURES: The research team assessed changes in student outcomes (eg, stress, anxiety, and stress management behaviors) using preintervention/postintervention surveys, including the Perceived Stress Scale (PSS), the State-Trait Anxiety Inventory-Form Y (STAI-Y), the stress management subscale of the Health-promoting Lifestyle Profile II (HPLP-II), the Rosenberg Self-Esteem Scale (RSES), the Locus of Control (LOC) questionnaire, and the Life Orientation Test-Revised (LOTR). Classroom observations using the Classroom Assessment Scoring System (CLASS)-Secondary were also completed to assess changes in classroom environment. RESULTS: Using a Bonferroni correction (P < .007), the study found that students experienced a significant reduction (P < .001) in measures of state-level anxiety on the STAI from pre- to postintervention. The study also found an increase in the use of stress management behaviors at that point. Using a Bonferroni correction (P < .007), the study found that students had significantly less perceived stress (P < .001), less state anxiety (P < .001) and trait anxiety (P < . 001), and increased use of positive stress management behaviors (P < .004) at the follow-up assessment in the fall of the following year. Using a Bonferroni correction (P < .002), the study found a significant increase in overall classroom productivity (eg, increased time spent on activities and instruction from pre- to postintervention). CONCLUSIONS: This study showed that teachers can lead an RR curriculum with fidelity and suggests that such a curriculum has positive benefits on student emotional and behavioral health and on classroom functioning.

Integrating a relaxation response-based curriculum into a public high school in Massachusetts.

Academic and societal pressures result in U.S. high school students feeling stressed. Stress management and relaxation interventions may help students increase resiliency to stress and overall well-being. The objectives of this study were to examine the feasibility (enrollment, participation and acceptability) and potential effectiveness (changes in perceived stress, anxiety, self-esteem, health-promoting behaviors, and locus of control) of a relaxation response (RR)-based curriculum integrated into the school day for high school students. The curriculum included didactic instruction, relaxation exercises, positive psychology, and cognitive restructuring. The intervention group showed significantly greater improvements in levels of perceived stress, state anxiety, and health-promoting behaviors when compared to the wait list control group. The intervention appeared most useful for girls in the intervention group. The results suggest that several modifications may increase the feasibility of using this potentially effective intervention in high schools.