Smoking relapse-prevention intervention for cancer patients: Study design and baseline data from the surviving SmokeFree randomized controlled trial.
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SUBMITTER: Diaz DB
PROVIDER: S-EPMC5564185 | biostudies-other | 2016 Sep
REPOSITORIES: biostudies-other
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Project description:ObjectivesTo pilot-test a Phone-based Postpartum Continuing Care (PPCC) protocol developed from existing evidence-based approaches to address both postpartum smoking relapse among low-income women who quit smoking during pregnancy and postpartum smoking increase among those who had cut down.MethodsOne hundred thirty low-income pregnant women who were current or recently quit tobacco smokers were recruited at their first prenatal appointment and randomized to either a Control (standard care) or Experimental (standard care + PPCC) group. An intent-to-treat analysis was conducted on biochemically verified data from 6 in-person interviews during pregnancy and postpartum. Feasibility with regard to recruitment, randomization, assessment, and implementation of PPCC were assessed, along with acceptability among the target population.ResultsPPCC was found to be feasible and acceptable to some participants, but not all. There were no significant differences in tobacco products per day at 6 months postpartum between groups; however, effect sizes differed at 6 weeks compared with 6 months postpartum. Similarly, there were no significant differences between groups in cessation rate (24% in each group) and past 90-day tobacco use (59 vs 55 days, for Control and Experimental groups, respectively).ConclusionsThe PPCC intervention did not differentially reduce tobacco use postpartum compared with a controlled comparison group, though it was found to be acceptable among a subpopulation of low-income pregnant women and feasible with regard to recruitment, randomization, assessment procedures, and implementation. Further research is needed to identify an intervention that significantly improves smoking relapse rates postpartum.
| S-EPMC5970014 | biostudies-literature
Project description:AimsMost people who quit smoking for a short term will return to smoking again in 12 months. We tested whether self-help booklets can reduce relapse in short-term quitters after receiving behavioural and pharmacological cessation treatment.DesignA parallel-arm, pragmatic individually randomized controlled trial.SettingSmoking cessation clinics in England. Participants People who stopped smoking for 4 weeks after receiving cessation treatment in stop smoking clinics.InterventionParticipants in the experimental group (n=703) were mailed eight booklets, each of which taught readers how to resist urges to smoke. Participants in the control group (n=704) received a leaflet currently used in practice.MeasurementsThe primary outcome was prolonged, carbon monoxide-verified abstinence from months 4 to 12. The secondary outcomes included 7-day self-reported abstinence at 3 and 12 months. Mixed-effects logistic regression was used to estimate treatment effects and to investigate possible effect modifying variables.FindingsThere were no statistically significant differences between the groups in prolonged abstinence from months 4 to 12 (36.9% versus 38.6%; odds ratio 0.93, 95% confidence interval 0.75-1.16; P=0.524). In addition, there were no significant differences between the groups in any secondary outcomes. However, people who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse.ConclusionsIn people who stop smoking successfully with behavioural support, a comprehensive self-help educational programme to teach people skills to identify and respond to high-risk situations for return to smoking did not reduce relapse.
| S-EPMC4832320 | biostudies-literature
Project description:Although the current smoking prevalence among Hispanics/Latinxs (10%) is lower than in non-Hispanic whites (15%), higher prevalence is observed among certain subgroups (e.g., Puerto Rican males, 19%). Hispanic/Latinx smokers face unique challenges such as lower awareness and acceptability of nicotine replacement aids, lower prevalence of using counseling or medication, and receiving less advice to quit by their health care providers. Despite these barriers to smoking cessation, few interventions specifically targeted to Hispanic/Latinx smokers have been developed and evaluated. This paper summarizes the design, methods, analysis plan, and sample baseline characteristics of an ongoing randomized controlled trial to assess the efficacy of a Spanish-language self-help smoking cessation intervention among Hispanics/Latinxs. Current smokers who prefer health education materials in Spanish were randomized to one of two conditions. The usual care group received a standard smoking cessation booklet developed by the National Cancer Institute. The intervention group received 10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18?months. All participants complete self-report surveys every 6?months over 2?years. Smoking abstinence is biochemically verified at 12- and 24-month follow-up. A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study. The primary outcome is self-reported 7-day point prevalence abstinence. If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.
| S-EPMC6815731 | biostudies-literature
Project description:Background and aimsSustained psychosocial support via online social groups may help former tobacco users maintain abstinence. This study aims to examine the effectiveness of participating in a WhatsApp social group for long-term smoking cessation.DesignTwo-arm, open-labelled, pragmatic, individually randomized controlled trial.SettingAll participants are service users of smoking cessation clinics, and all interventions are delivered via mobile phones.ParticipantsParticipants included 1008 adult quitters who self-report no tobacco use in the past 3-30 days.InterventionsThe intervention group (n = 504) will join a WhatsApp social group to receive standardized and theory-based reminders of smoking relapse prevention and participate in discussion with other WhatsApp group members using their own mobile phones. All social groups will be led by counselors or specialist nurse practitioners. The control group (n = 504) will receive similar reminders via short messages to their own mobile phones but will not interact with other participants. The intervention duration for both groups is 8 weeks. Both groups will receive a booklet at baseline about how to prevent smoking relapse.MeasurementsThe primary outcome is biochemically validated tobacco abstinence at 12 months after consent.CommentsThe findings will provide evidence concerning the utility of operating online social group discussion for prevention of smoking relapse and sustaining long-term abstinence.
| S-EPMC7496257 | biostudies-literature
Project description:Small employers, especially those in low-wage industries, frequently lack the capacity and resources to implement evidence-based health promotion interventions without support and assistance. The purpose of this paper is to (a) describe the intervention design and study protocol of the HealthLinks Trial and (b) report baseline findings. This study is a three-arm randomized controlled trial testing the impact of the HealthLinks intervention on worksites' adoption and implementation of evidence-based interventions. Group 1 will receive HealthLinks, Group 2 will receive HealthLinks plus wellness committees, and Group 3 will be a delayed control group. Seventy-eight employers are participating in the study; and 3302 employees across the worksites participated in the baseline data collection. Employers and employees will participate in follow-up surveys at one and two years after baseline to measure implementation (one year) and maintenance (two years) of HealthLinks interventions. Study outcomes will determine whether HealthLinks is an effective approach to increasing evidence-based health promotion in small, low-wage worksites and whether wellness committees are a capacity-building tool that increases HealthLinks' effectiveness.
| S-EPMC4885764 | biostudies-literature
Project description:BackgroundTobacco use is the largest preventable cause of death. Smoking cessation interventions that use implementation intentions show promising results. Implementation intentions are if-then plans that specify a certain behaviour within a situational context. This study will examine whether involving a non-smoking partner could improve planning interventions, and whether and which partner interactions underlie this effectiveness.MethodsThis single-blind randomized controlled trial has a longitudinal design with a baseline questionnaire, end-of-day measurements for three weeks starting on the quit date, and a follow-up questionnaire after three months.Participantssingle-smoking couples who live together and are in a relationship for more than one year.Settingcouples are randomized to either a dyadic or individual planning condition. After the intervention the smoker attempts to quit smoking and the diary measurements start.MeasurementsThe primary outcome variable is smoking abstinence. Secondary outcome measures are smoking behaviour and relationship satisfaction. Partner interactions are examined as a possible mediator.DiscussionThis RCT is the first to examine the effectiveness of dyadic planning to quit smoking in single-smoking couples. Partner interactions are thought to play an important role during the quit attempt, and therefore in the effectiveness of the intervention. This RCT will provide more insight into which daily partner interactions are beneficial for smoking abstinence and the couples' relationship satisfaction, and whether the type of intervention is related to different types or levels of partner interactions and smoking behaviour. When proven effective, this planning intervention in combination with coaching for the non-smoking partner will be a valuable and low-cost addition to existing smoking interventions.Trial registrationThe trial is retrospectively registered on 19/04/2017 on www.trialregister.nl ( TC: 6398 ).
| S-EPMC6233499 | biostudies-literature
Project description:BackgroundAbstaining from smoking after a cancer diagnosis is critical to mitigating the risk of multiple adverse health outcomes. Although many patients with cancer attempt to quit smoking, the majority relapse. The current randomized controlled trial evaluated the efficacy of adapting an evidence-based smoking relapse prevention (SRP) intervention for patients with cancer.MethodsThe trial enrolled 412 patients newly diagnosed with cancer who had recently quit smoking. Participants were randomized to usual care (UC) or SRP. Participants in the UC group received the institution's standard of care for treating tobacco use. Participants in the SRP group in addition received a targeted educational DVD plus a validated self-help intervention for preventing smoking relapse. The primary outcome was smoking abstinence at 2 months, 6 months, and 12 months.ResultsAbstinence rates for participants in the SRP and UC groups were 75% versus 71% at 2 months and 69% versus 64% at 6 months (Ps > .20). At 12 months, abstinence rates among survivors were 68% for those in the SRP group and 63% for those in the UC group (P = .38). Post hoc analyses revealed that across 2 months and 6 months, patients who were married/partnered were more likely to be abstinent after SRP than UC (P = .03).ConclusionsA smoking relapse prevention intervention did not reduce relapse rates overall, but did appear to have benefited those participants who had the social support of a partner. Future work is needed to extend this effect to the larger population of patients.
| S-EPMC7771373 | biostudies-literature
Project description:PURPOSE: Targeted interventions to reduce the risk and increase the early detection of melanoma have the potential to save lives. We aimed to assess the effect of such an intervention on patient prevention behavior. METHODS: We conducted a pilot clustered randomized controlled trial, comparing a targeted screening and education intervention with a conventional information-based campaign in 20 private surgeries in western France. In the intervention group, 10 general practitioners identified patients at elevated risk for melanoma with a validated assessment tool, the Self-Assessment Melanoma Risk Score (SAMScore), examined their skin, and counseled them using information leaflets. In the control group, 10 general practitioners displayed a poster and the leaflets in their waiting room and examined patients' skin at their own discretion. The main outcome measures were sunbathing and skin self-examinations among patients at elevated risk, assessed 5 months later with a questionnaire. RESULTS: Analyses were based on 173 patients. Compared with control patients, intervention patients were more likely to remember the campaign (81.4% vs 50.0%, P = .0001) and to correctly identify their elevated risk of melanoma (71.1% vs 42.1%, P = .001). Furthermore, intervention patients had higher levels of prevention behaviors: they were less likely to sunbathe in the summer (24.7% vs 40.8%, P = .048) and more likely to have performed skin self-examinations in the past year (52.6% vs 36.8%, P = .029). The intervention was not associated with any clear adverse effects, although there were trends whereby intervention patients were more likely to worry about melanoma and to consult their general practitioner again about the disease. CONCLUSIONS: The combination of use of the SAMScore and general practitioner examination and counseling during consultations is an efficient way to promote patient behaviors that may reduce melanoma risk. Extending the duration of follow-up and demonstrating an impact on morbidity and mortality remain major issues for further research.
| S-EPMC3896535 | biostudies-literature
Project description:Smoking cessation is a primary method of reducing excess mortality and morbidity. Unfortunately, the vast majority of cessation attempts end in eventual relapse. Relapse-prevention interventions have shown some success at improving the long-term maintenance of tobacco abstinence among individuals motivated to abstain. However, involuntary tobacco abstinence (e.g., military training, hospitalization, incarceration) presents another opportunity for intervention to prevent relapse. During basic military training (BMT), tobacco use is strictly forbidden in all service branches, but tobacco relapse (and initiation) following BMT is extremely high. This paper reports on the design, intervention development, and baseline characteristics of a randomized controlled trial testing minimal interventions designed to prevent tobacco relapse among United States Air Force (USAF) personnel following BMT. Participants are randomized by squadron to receive either a standard smoking-cessation booklet, a new motivation-based booklet designed specifically for USAF personal, or the latter booklet combined with a brief, face-to-face motivational session. Primary outcomes will be self-reported tobacco use at 12 and 24month follow-up. Given that the Department of Defense is the world's largest employer, the potential of leveraging involuntary tobacco abstinence during BMT into extended abstinence has substantial public health significance.
| S-EPMC4024360 | biostudies-literature
Project description:BackgroundQuit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence.ObjectiveOur aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently.MethodsThis was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days.ResultsFewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators' posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants' posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant.ConclusionsThe intervention via the WhatsApp social group was effective in reducing relapse probably because of enhanced discussion and social support. Inactive discussion in the Facebook social group might have attributed to the lower effectiveness.ClinicaltrialClinicaltrials.gov NCT02007369; https://clinicaltrials.gov/show/NCT02007369 (Archived by WebCite® at http://www.webcitation.org/6c3RbltQG).
| S-EPMC4642789 | biostudies-literature