Dataset Information

Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Results of a pilot randomized control trial.

ABSTRACT:

Introduction

Menstrual phase influences cigarette smoking-related outcomes. Telephone-based cessation programs (e.g., quitlines) may incorporate the role of the menstrual cycle in an effort to tailor interventions for women.

Purpose

The goal of this preliminary randomized clinical trial was to examine the feasibility and acceptability of timing quit date to menstrual phase in women in a quitline setting.

Methods

We recruited treatment-seeking women with regular menstrual cycles between the ages of 18-40 years. Participants were randomized to the follicular phase (FP; quit date set 6-8 days post onset of menses) or standard of care (SC; no menstrual timing of quit date). All participants received four weeks of nicotine replacement therapy transdermal patch concurrent with six weeks of telephone-based counseling. We explored self-reported and biochemically-verified seven-day point prevalence abstinence at end-of-treatment and three-month follow-up.

Results

Participants (n = 119; FP: n = 58, SC: n = 61) were, on average, 33.4 years old and smoked 13.6 cigarettes/day. The median number of counseling sessions completed was 6 out of 6 available, and 66% of participants completed the intervention. Over 90% of participants reported they would recommend this study to friends/family. Cessation rates did not significantly vary by randomization.

Conclusions

Results of this preliminary trial indicate that timing quit date to FP is an acceptable and feasible approach to address smoking cessation in women of reproductive age. While we observed similar smoking cessation rates between groups, this preliminary study was not fully powered to determine efficacy. Therefore, the feasibility and acceptability results indicate that a fully-powered efficacy trial is warranted.

SUBMITTER: Allen A

PROVIDER: S-EPMC8629968 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Results of a pilot randomized control trial.

Allen Alicia A Skobic Iva I Bell Melanie L ML Medvescek Kristina K Allen Sharon S Collins Bradley B Nair Uma U

Addictive behaviors 20211014

<h4>Introduction</h4>Menstrual phase influences cigarette smoking-related outcomes. Telephone-based cessation programs (e.g., quitlines) may incorporate the role of the menstrual cycle in an effort to tailor interventions for women.<h4>Purpose</h4>The goal of this preliminary randomized clinical trial was to examine the feasibility and acceptability of timing quit date to menstrual phase in women in a quitline setting.<h4>Methods</h4>We recruited treatment-seeking women with regular menstrual cy ...[more]

PMID: 34739974

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Project description:BackgroundAlthough many smoking cessation smartphone apps exist, few have been independently evaluated, particularly in older populations. In 2017, of the 112 commercially available smoking cessation apps in Australia, only 6 were deemed to be of high quality, in that they partially adhered to Australian guidelines. Mobile health (mHealth) apps have the potential to modify smoking behavior at a relatively low cost; however, their acceptability in older smokers remains unknown. Rigorous scientific evaluation of apps is thus urgently needed to assist smokers and clinicians alike.ObjectiveWe conducted a pilot randomized controlled trial to evaluate the feasibility of a large-scale trial to assess the use and acceptability of a high-quality smoking cessation app in older smokers.MethodsAdult inpatient and outpatient smokers with computer and smartphone access were recruited face to face and via telephone interviews from Metropolitan Hospitals in Brisbane, Australia. Participants were randomized 1:1 to the intervention (requested to download the "My QuitBuddy" smoking cessation app on their smartphone) or the control group (provided access to a tailored smoking cessation support webpage [Quit HQ]). The My QuitBuddy app is freely available from app stores and provides personalized evidenced-based smoking cessation support. Quit HQ offers regular email support over 12 weeks. No training or instructions on the use of these e-resources were given to participants. Outcomes at 3 months included recruitment and retention rates, use and acceptability of e-resource (User Version of the Mobile App Rating Scale [uMARS]), changes in quitting motivation (10-point scale), and self-reported smoking abstinence.ResultsWe randomized 64 of 231 potentially eligible individuals (27.7%). The mean age of participants was 62 (SD 8). Nicotine dependence was moderate (mean Heaviness of Smoking Index [HSI] 2.8 [SD 1.2]). At 3 months the retention rate was (58/64, 91%). A total of 15 of 31 participants in the intervention arm (48%) used the app at least once, compared with 10 of 33 (30%) in the control arm. uMARS scores for e-resource use and acceptability were statistically similar (P=.29). Motivation to quit was significantly higher in the intervention arm compared with the control arm (median 6 [IQR 4-8] versus 4 [IQR 4-5], respectively, P=.02). According to the intention-to-treat analysis, smoking abstinence was nonsignificantly higher in the intervention group (4/31 [13%], 95% CI 4%-30%, versus 2/33 [6%], 95% CI 1%-20%; P=.42). The estimated number needed to treat was 14.ConclusionsInternet and mHealth smoking cessation resources appear acceptable to a minority of older smokers. Smokers who engaged with the allocated e-resources rated them equally, and there were trends toward greater uptake, increased motivation, and higher abstinence rates in the app group; however, only the change in motivation reached statistical significance (median score 6 versus 4, respectively, P=.02). This results of this pilot study suggest that apps may improve quit outcomes in older adults who are willing to use them. Further research into user-app interactions should be undertaken to facilitate improvements in app design and consumer engagement. These favorable trends should be explored in larger trials with sufficient statistical power.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12619000159156; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376849&isReview=true.

Project description:IntroductionSmoking prior to major thoracic surgery is the biggest risk factor for development of postoperative pulmonary complications, with one in five patients continuing to smoke before surgery. Current guidance is that all patients should stop smoking before elective surgery yet very few are offered specialist smoking cessation support. Patients would prefer support within the thoracic surgical pathway. No study has addressed the effectiveness of such an intervention in this setting on cessation. The overall aim is to determine in patients who undergo major elective thoracic surgery whether an intervention integrated (INT) into the surgical pathway improves smoking cessation rates compared with usual care (UC) of standard community/hospital based NHS smoking support. This pilot study will evaluate feasibility of a substantive trial.Methods and analysisProject MURRAY is a trial comparing the effectiveness of INT and UC on smoking cessation. INT is pharmacotherapy and a hybrid of behavioural support delivered by the trained healthcare practitioners (HCPs) in the thoracic surgical pathway and a complimentary web-based application. This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust. The primary objective is to establish the proportion of those eligible who agree to participate. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs.Ethics and disseminationThe study has obtained ethical approval from NHS Research Ethics Committee (REC number 19/WM/0097). Dissemination plan includes informing patients and HCPs; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full application dependent on the success of the study.Trial registration numberNCT04190966.

Project description:BackgroundIn Peru's urban communities, tobacco smoking generally starts during adolescence and smoking prevalence is highest among young adults. Each year, many attempt to quit, but access to smoking cessation programs is limited. Evidence-based text messaging smoking cessation programs are an alternative that has been successfully implemented in high-income countries, but not yet in middle- and low-income countries with limited tobacco control policies.ObjectiveThe objective was to assess the feasibility and acceptability of an short message service (SMS) text message-based cognitive behavioral smoking cessation program for young adults in Lima, Peru.MethodsRecruitment included using flyers and social media ads to direct young adults interested in quitting smoking to a website where interested participants completed a Google Drive survey. Inclusion criteria were being between ages 18 and 25 years, smoking at least four cigarettes per day at least 6 days per week, willing to quit in the next 30 days, owning a mobile phone, using SMS text messaging at least once in past year, and residing in Lima. Participants joined one of three phases: (1) focus groups and in-depth interviews whose feedback was used to develop the SMS text messages, (2) validating the SMS text messages, and (3) a pilot of the SMS text message-based smoking cessation program to test its feasibility and acceptability among young adults in Lima. The outcome measures included adherence to the SMS text message-based program, acceptability of content, and smoking abstinence self-report on days 2, 7, and 30 after quitting.ResultsOf 639 participants who completed initial online surveys, 42 met the inclusion criteria and 35 agreed to participate (focus groups and interviews: n=12; validate SMS text messages: n=8; program pilot: n=15). Common quit practices and beliefs emerged from participants in the focus groups and interviews informed the content, tone, and delivery schedule of the messages used in the SMS text message smoking cessation program. A small randomized controlled pilot trial was performed to test the program's feasibility and acceptability; nine smokers were assigned to the SMS text message smoking cessation program and six to a SMS text message nutrition program. Participant retention was high: 93% (14/15) remained until day 30 after quit day. In all, 56% of participants (5/9) in the SMS text message smoking cessation program reported remaining smoke-free until day 30 after quit day and 17% of participants (1/6) in the SMS text message nutrition program reported remaining smoke-free during the entire program. The 14 participants who completed the pilot reported that they received valuable health information and approved the delivery schedule of the SMS text messages.ConclusionsThis study provides initial evidence that a SMS text message smoking cessation program is feasible and acceptable for young adults residing in Lima.

Project description:BackgroundHIV self-testing (HIVST) is an innovative HIV testing approach that effectively reaches those who do not otherwise test, including key populations (KPs). Despite potential benefits, HIVST is not currently implemented in Pakistan. The high risk of HIV among transgender (TGs) persons is among the highest risk group for HIV in Pakistan, yet knowledge of HIV status remains low in this key population group. We conducted a pilot project to assess the acceptability and feasibility of distributing HIVST to TGs in Larkana.MethodsEligible participants were 18 years or above and self-identified as transgender ("hijra"). One oral fluid HIVST kit per person was distributed free of cost in the community by trained transgender peer outreach workers (ORW). Participants could request a demonstration of the HIVST procedure before performing self-testing which was provided by the trained ORW. Demographic characteristics of participants were collected. The ORW followed up with phone calls two days later to record if HIVST kits were used, the results, and whether assistance was required.ResultsBetween November 2020 and February 2021, 150 HIVST kits were distributed to eligible TGs. The average age of participants was 25.5 years (standard deviation: 7.0). Over a third (52, 34.7%) had no formal education, while (16, 10.6%) had attended at least five years of schooling. Over one-third (58, 38.6%) of participants were first-time testers. One hundred and thirty-nine (92.7%) participants reported their results within two days. For the remaining 11 participants, ORWs had to contact them. All participants reported using HIVST kits within three days. A majority (141, 94%) used the kit in their homes, and the remaining nine (6%) used it at the community-based organization's office. Overall, a small proportion (11, 7.3%) of participants requested a demonstration of the test procedure before performing HIVST. Four (2.7%) participants who had performed unsupervised self-tests reported reactive HIVST results; all were linked to treatment within five working days once their HIV result was confirmed. The majority (136, 90.6%) of participants felt that self-testing was easy to perform independently, and 143 (95%) reported that they would recommend HIVST to their peers.ConclusionHIVST is acceptable among TGs and identified by first-time testers as undiagnosed infections. Peer-led distribution appears to be a feasible approach for implementation in this setting. HIVST should be considered for routine implementation and scale up to reduce testing gaps among Pakistan's key population, particularly TGs.

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Dataset Information

Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Results of a pilot randomized control trial.

Introduction

Purpose

Methods

Results

Conclusions

Publications

Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Results of a pilot randomized control trial.

Similar Datasets

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