Dataset Information

Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation.

ABSTRACT:

Introduction

A recent meta-analysis of Internet interventions for smoking cessation found mixed evidence regarding effectiveness. One explanation may be differential use of non-assigned cessation treatments-including other Internet programs-that either amplify or mask study intervention effects. We examined the impact of non-assigned treatment use on cessation outcomes in The iQUITT Study, a randomized trial of Internet and telephone treatment for smoking cessation.

Methods

Participants were randomized to a basic Internet (BI) comparison condition (N = 675), enhanced Internet (EI: N = 651), or EI plus telephone counseling (EI+P: N = 679). The primary outcome was 30-day point prevalence abstinence (ppa) at 3 and 6 months. Assigned intervention use was assessed with automated tracking data. Assessment of non-assigned treatments included pharmacotherapy, behavioral, alternative, and non-study Internet treatments. Univariate and multivariate logistic regression models examined whether non-assigned treatment use was associated with 30-day ppa.

Results

About 70% of participants used at least one non-assigned treatment. A higher rate of non-study Internet treatment among BI participants was the only treatment group difference at both 3 and 6 months. Multivariate models controlling for condition and baseline predictors of non-assigned treatment use showed that high-intensity non-study Internet treatment was positively associated with 30-day ppa at 3 and 6 months, and pharmacotherapy and behavioral treatment use was negatively associated with 30-day ppa at 6 months.

Conclusions

Non-assigned treatment use is an important factor to consider when evaluating Internet cessation interventions. Results highlight methodological issues in selecting a comparison condition. Researchers should report non-assigned treatment use alongside main trial outcomes.

SUBMITTER: Cobb CO

PROVIDER: S-EPMC4207870 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Publications

Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation.

Cobb Caroline O CO Graham Amanda L AL

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20140508 10

<h4>Introduction</h4>A recent meta-analysis of Internet interventions for smoking cessation found mixed evidence regarding effectiveness. One explanation may be differential use of non-assigned cessation treatments-including other Internet programs-that either amplify or mask study intervention effects. We examined the impact of non-assigned treatment use on cessation outcomes in The iQUITT Study, a randomized trial of Internet and telephone treatment for smoking cessation.<h4>Methods</h4>Partic ...[more]

PMID: 24812022

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Project description:BackgroundNondaily smoking is a widespread and increasingly prevalent pattern of use. To date, no effective treatment approach for nondaily smoking has been identified.ObjectiveThis study aimed to conduct an unblinded randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app, a smartphone app for smoking cessation, designed specifically for people who smoke less than daily, within the framework of positive psychology.MethodsOverall, 226 adults who smoke less than daily were recruited on the web and asked to undertake a quit attempt while using assigned smoking cessation support materials. Participants were randomly assigned to 1 of 3 materials: the SiS smartphone app, the National Cancer Institute's smartphone app QuitGuide (QG), or the National Cancer Institute's smoking cessation brochure, "Clearing the Air" (CtA). All participants engaged in a 15-minute scripted onboarding phone call and were introduced to their support materials to use for the next 7 weeks. Follow-up self-assessment web surveys were sent 2, 6, 12, and 24 weeks after participants' initially chosen quit date (ie, 1 week after onboarding). The primary outcome for this study was self-efficacy to remain abstinent from smoking at treatment end. Secondary outcomes assessed treatment acceptability, treatment feasibility (eg, number of days of app use, time spent using app, and use of smoking cessation strategies), and secondary proof-of-concept efficacy outcomes (eg, positive affect, craving, and attitudes toward smoking). Smoking outcomes (ie, 30-day point prevalence abstinence and smoking reduction) were also assessed.ResultsResults indicated a significant effect of treatment on the primary outcome, where SiS participants (n=80) reported higher self-efficacy to abstain from smoking at the end of treatment than the 2 control groups (QG: n=75; P=.02; Cohen d=0.40 and CtA: n=71; P=.007; Cohen d=0.50). This effect was also significant on both self-efficacy subscales (ie, internal cues and external cues) with effect sizes ranging from Cohen d=0.34 to 0.50 across the pairwise comparisons. The SiS app group also reported lower craving (QG: P=.005; Cohen d=-0.57 and CtA: P=.005; Cohen d=-0.57) and higher positive affect than QG (QG: P=.01; Cohen d=0.44 and CtA: P=.05; Cohen d=0.38); attitudes toward smoking were largely similar across groups. Treatment acceptability was comparable across groups (P values for all groups >.05; Cohen d range 0.06-0.23). Treatment feasibility measures indicated that participants used the SiS app on 33 out of 49 days, for 35 to 40 minutes per week, resulting in greater use of smoking cessation strategies than QG (QG: P=.04; Cohen d=0.38 and CtA: P=.16; Cohen d=0.24).ConclusionsThese findings provide strong evidence for the conceptual underpinnings of the SiS app, and thereby provide compelling justification for conducting a large-scale randomized controlled trial that can test the effectiveness of the SiS app on smoking cessation.Trial registrationClinicalTrials.gov NCT04672239; https://clinicaltrials.gov/study/NCT04672239.International registered report identifier (irrid)RR2-10.2196/40867.

Project description:BackgroundLung cancer mortality is reduced via low-dose computed tomography screening and treatment of early-stage disease. Evidence-based smoking cessation treatment in the lung screening setting can further reduce mortality. We report the results of a cessation trial from the National Cancer Institute's Smoking Cessation at Lung Examination collaboration.MethodsEligible patients (n = 818) aged 50-80 years were randomly assigned (May 2017-January 2021) to the intensive vs minimal arms (8 vs 3 phone sessions plus 8 vs 2 weeks of nicotine patches, respectively). Bio-verified (primary) and self-reported 7-day abstinence rates were assessed at 3, 6, and 12 months post random assignment. Logistic regression analyses evaluated the effects of study arm. All statistical tests were 2-sided.ResultsParticipants reported 48.0 (SD = 17.2) pack-years, and 51.6% were not ready to quit in less than 30 days. Self-reported 3-month quit rates were statistically significantly higher in the intensive vs minimal arm (14.3% vs 7.9%; odds ratio [OR] = 2.00, 95% confidence interval [CI] = 1.26 to 3.18). Bio-verified abstinence was lower but with similar relative differences between arms (9.1% vs 3.9%; OR = 2.70, 95% CI = 1.44 to 5.08). Compared with the minimal arm, the intensive arm was more effective among those with greater nicotine dependence (OR = 3.47, 95% CI = 1.55 to 7.76), normal screening results (OR = 2.58, 95% CI = 1.32 to 5.03), high engagement in counseling (OR = 3.03, 95% CI = 1.50 to 6.14), and patch use (OR = 2.81, 95% CI = 1.39 to 5.68). Abstinence rates did not differ statistically significantly between arms at 6 months (OR = 1.2, 95% CI = 0.68 to 2.11) or 12 months (OR = 1.4, 95% CI = 0.82 to 2.42).ConclusionsDelivering intensive telephone counseling and nicotine replacement with lung screening is an effective strategy to increase short-term smoking cessation. Methods to maintain short-term effects are needed. Even with modest quit rates, integrating cessation treatment into lung screening programs may have a large impact on tobacco-related mortality.

Project description:IntroductionHospitalization is a unique opportunity for smoking cessation, but prior interventions have measured efficacy with narrowly defined populations. The objective of this study was to enroll smokers admitted to two "safety net" hospitals and compare the effectiveness of two post-discharge cessation interventions.DesignA randomized comparative effectiveness trial was conducted.Setting/participantsAt two New York City public hospitals, every hospitalized patient identified as a smoker (based on admission records) was approached. Inclusion criteria were: smoked cigarettes in the past 30 days; spoke English, Spanish, or Mandarin; had a U.S. phone number; not discharged to an institution where follow-up or smoking was limited; and not pregnant/breastfeeding. Of 18,797 patients identified as current smokers between July 2011 and April 2014, a total of 3,047 (16%) were discharged before being approached, 3,273 (17%) were not current smokers, 4,026 (21%) had no U.S. phone number, 2,831 (15%) were ineligible for other reasons, and 3,983 (21%) refused participation. In total, 1,618 (9%) participants enrolled in the study. During follow-up, 69% of participants were reached at 2 months and 68% at 6 months.InterventionAt discharge, participants were randomized to multisession telephone counseling from study staff (n=804) or referral to the state quitline for proactive outreach and counseling (n=814).Main outcome measuresSelf-reported abstinence at 6 months was measured. Analyses were conducted in late 2015.ResultsOne quarter of participants were homeless or in unstable housing, 60% had a history of substance abuse, 43% reported current hazardous drinking, and half had a psychiatric diagnosis other than substance abuse. At follow-up, the rate of abstinence (30-day point prevalence) was higher in the intensive counseling arm than the quitline arm at 2 months (29.0% vs 20.7%; relative risk=1.40; 95% CI=1.13, 1.73) and 6 months (37.4% vs 31.5%; relative risk=1.19; 95% CI=1.01, 1.40).ConclusionsIntensive counseling was more effective than referral to the state quitline. Long-term abstinence was excellent in both groups. Many patients were not eligible for enrollment despite minimal exclusion criteria.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01363245.

Dataset Information

Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation.

Introduction

Methods

Results

Conclusions

Publications

Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation.

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