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

ABSTRACT: 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.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.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.

SUBMITTER: Park ER

PROVIDER: S-EPMC5035625 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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

Park Elyse R ER Ostroff Jamie S JS Perez Giselle K GK Hyland Kelly A KA Rigotti Nancy A NA Borderud Sarah S Regan Susan S Muzikansky Alona A Friedman Emily R ER Levy Douglas E DE Holland Susan S Eusebio Justin J Peterson Lisa L Rabin Julia J Miller-Sobel Jacob J Gonzalez Irina I Malloy Laura L O'Brien Maureen M de León-Sanchez Suhana S Whitlock C Will CW

Contemporary clinical trials 20160719

<h4>Background</h4>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.<h4>Methods/design</h4>A two-arm, two-site randomized controlled comparative effectiven ...[more]

PMID: 27444428

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Project description:Most smokers with mental illness do not receive tobacco cessation treatment.To determine whether integrating smoking cessation treatment into mental health care for veterans with posttraumatic stress disorder (PTSD) improves long-term smoking abstinence rates.A randomized controlled trial of 943 smokers with military-related PTSD who were recruited from outpatient PTSD clinics at 10 Veterans Affairs medical centers and followed up for 18 to 48 months between November 2004 and July 2009.Smoking cessation treatment integrated within mental health care for PTSD delivered by mental health clinicians (integrated care [IC]) vs referral to Veterans Affairs smoking cessation clinics (SCC). Patients received smoking cessation treatment within 3 months of study enrollment.Smoking outcomes included 12-month bioverified prolonged abstinence (primary outcome) and 7- and 30-day point prevalence abstinence assessed at 3-month intervals. Amount of smoking cessation medications and counseling sessions delivered were tested as mediators of outcome. Posttraumatic stress disorder and depression were repeatedly assessed using the PTSD Checklist and Patient Health Questionnaire 9, respectively, to determine if IC participation or quitting smoking worsened psychiatric status.Integrated care was better than SCC on prolonged abstinence (8.9% vs 4.5%; adjusted odds ratio, 2.26; 95% confidence interval [CI], 1.30-3.91; P = .004). Differences between IC vs SCC were largest at 6 months for 7-day point prevalence abstinence (78/472 [16.5%] vs 34/471 [7.2%], P < .001) and remained significant at 18 months (86/472 [18.2%] vs 51/471 [10.8%], P < .001). Number of counseling sessions received and days of cessation medication used explained 39.1% of the treatment effect. Between baseline and 18 months, psychiatric status did not differ between treatment conditions. Posttraumatic stress disorder symptoms for quitters and nonquitters improved. Nonquitters worsened slightly on the Patient Health Questionnaire 9 relative to quitters (differences ranged between 0.4 and 2.1, P = .03), whose scores did not change over time.Among smokers with military-related PTSD, integrating smoking cessation treatment into mental health care compared with referral to specialized cessation treatment resulted in greater prolonged abstinence.clinicaltrials.gov Identifier: NCT00118534.

Project description:Low back pain is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of permanent disability in the US Army. For certain elements of care, the timing may be just as important as the type of care. The purpose of this study is to assess the impact of the timing of access to a physical therapist by patients with low back pain, by looking at outcomes and low back pain-related healthcare utilization over a 1-year period.This trial will be a two-arm pragmatic randomized clinical trial occurring at two different clinical sites in the Military Health System. We will assess outcomes and related downstream costs for patients who access physical therapy at the primary care level compared to those that receive usual care only. There will be 220 consecutive patients randomized to receive care in either group (early physical therapy or usual care only) for the first 4 weeks, and these patients will then be allowed to receive any additional care dictated by their primary care provider for the following year. The primary outcome measure is the Oswestry Disability Index. Secondary outcome measures are the Global Rating of Change, Patient Satisfaction and 1-year healthcare utilization. Follow-ups will occur at 4 weeks, 3 months and 1 year.This trial takes a pragmatic approach to delivering care by enabling a usual care environment for managing low back pain, while also allowing immediate access to physical therapy. After the initial intervention, the patient's primary provider can continue to manage the patient as he/she normally would in practice. The Military Health System Data Repository will capture all low back pain-related healthcare utilization that occurs in order to allow for a comparison between groups. Analysis from retrospective cohorts has shown improved outcomes and decreased costs for patients that received early versus late physical therapy, but this has yet to be shown in prospective trials.ClinicalTrials.Gov NCT01556581 initially on 14 March 2012.

Project description:Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis.In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ?40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum.This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism.NCT01225133.

Project description:There is a high prevalence of smoking and high burden of tobacco-related diseases among low-income populations. Effective, evidenced-based smoking cessation treatments are available, but low-income smokers are less likely than higher-income smokers to use these treatments, especially the most comprehensive forms that include a combination of pharmacotherapy and intensive behavioral counseling.The primary objectives of this randomized controlled trial are to compare the effects of a proactive tobacco treatment intervention compared to usual care on population-level smoking abstinence rates and tobacco treatment utilization rates among a diverse population of low-income smokers, and to determine the cost-effectiveness of proactive tobacco treatment intervention. The proactive care intervention systematically offers low-income smokers free and easy access to evidence-based treatments and has two primary components: (1) proactive outreach to current smokers in the form of mailed invitation materials and telephone calls containing targeted health messages, and (2) facilitated access to free, comprehensive, evidence-based tobacco cessation treatments in the form of NRT and intensive, telephone-based behavioral counseling. The study aims to include a population-based sample (N?=?2500) of adult smokers enrolled in the Minnesota Health Care Programs (MHCP), a state-funded health insurance plan for low-income persons. Baseline data is obtained from MHCP administrative databases and a participant survey that is conducted prior to randomization. Outcome data is collected from a follow-up survey conducted 12 months after randomization and MHCP administrative data. The primary outcome is six-month prolonged smoking abstinence at one year and is assessed at the population level. All randomized individuals are asked to complete the follow-up survey, regardless of whether they participated in tobacco treatment. Data analysis of the primary aims will follow intent-to-treat methodology.There is a critical need to increase access to effective tobacco dependence treatments. This randomized trial evaluates the effects of proactive outreach coupled with free NRT and telephone counseling on the population impact of tobacco dependence treatment. If proven to be effective and cost-effective, national dissemination of proactive treatment approaches would reduce tobacco-related morbidity, mortality, and health care costs for low income Americans.ClinicalTrials.gov: NCT01123967.

Project description:BackgroundWorld-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders.Methods/designThis two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. orControl groupStandard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients.DiscussionForty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.Trial registration[ClinicalTrials.gov: Identifier NCT00945204].

Project description:A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care.A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation, post-discharge utilization of smoking cessation treatment, hospital readmissions and emergency room visits, and program cost per quit.This study tests a disseminable smoking intervention model for hospitalized smokers. If effective and widely adopted, it could help to reduce population smoking rates and thereby reduce tobacco-related mortality, morbidity, and health care costs.United States Clinical Trials Registry NCT01177176.

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

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

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