Trial · NCT03808818
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated) | At 6 months | We will define 7-day point-prevalence by saliva cotinine (\< 15 ng/ml) or expired air CO (\<10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. COVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim. |
| Secondary | Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated) | At 3 months | We will define 7-day point-prevalence by saliva cotinine (\< 15 ng/ml) or expired air CO (\<10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. COVID-19 restrictions prevented any saliva or CO sample collection or analysis as part of this study. Therefore, no biochemical outcome results are available for reporting for this aim. |
| Secondary | 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report | At 6 months | 7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked. |
| Secondary | 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report | At 3 months | 7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked. |
| Secondary | Self-reported Continuous Tobacco Abstinence | At 3months and 6 months | Continued cessation of cigarette use was analyzed by comparing 3- and 6-month 7-day point prevalence in smoking cessation. If participants withdrew or did not answer the survey, they were marked as having recently smoked. Thus, participants needed to complete the survey and indicate that they had stopped tobacco use at both 3- and 6-month timepoints to be identified as having continuous cessation. |
| Secondary | Sustained Tobacco Abstinence at 6 Months (Not Evaluated) | At 6 months | To qualify as a sustained abstinence at 6 months, the participant must qualify as biochemically-verified 7-day point prevalence cigarette abstinence at 3 and 6 months. Chi-square tests will be used to compare the outcomes between treatment groups. COVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim. |
| Secondary | Significant Reduction in Smoking | baseline and 6 months | Significant reduction in daily smoking from baseline to 6 months was defined as \> 50% reduction in reported number of cigarettes per day. Patients were ask to report the average number of cigarettes smoked per day on the 6mo and baseline surveys. if Xb is the average number smoked at baseline and X6 is the average number smoked at 6 months Then the reduction was calculated as (Xb-X6)/Xb |
| Secondary | Significant Reduction in Smoking @ 3 Months | baseline and 3 months | Significant reduction in daily smoking from baseline to 6 months was defined as \> 50% reduction in reported number of cigarettes per day. Patients were ask to report the average number of cigarettes smoked per day on the 3mo and baseline surveys. if Xb is the average number smoked at baseline and X3 is the average number smoked at 3 months Then the reduction was calculated as (Xb-X3)/Xb |
| Other | Potential Effect of Sociodemographics on Treatment Effectiveness | Up to 6 months | Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments. |
| Other | Potential Effect of Medical and Smoking History on Treatment Effectiveness | Up to 6 months | Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments. |
| Other | Potential Effect of Cancer Variables on Treatment Effectiveness | Up to 6 months | Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments. |
| Other | Implementation of the Intervention at Community Oncology Sites | Up to 36 months | Will follow Proctor and colleagues' recommended taxonomy for measurement of implementation outcomes. Will measure acceptability (satisfaction with content/delivery), adoption (program uptake), appropriateness (relevance), cost, and treatment fidelity/adaptation and penetration (reach) and sustainability. These implementation outcomes will be assessed with mixed methods using qualitative and quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcomes (acceptability, adoption, appropriateness, fidelity, cost, penetration and sustainability) and conduct treatment group comparisons (i.e., acceptability). |
| Other | Intervention Acceptability (Satisfaction With Content/Delivery) at Community Oncology Sites | Up to 36 months | Outcome will be assessed with mixed methods using qualitative \& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. |
| Other | Intervention Adoption (Program Uptake) at Community Oncology Sites | Up to 36 months | Outcome will be assessed with mixed methods using qualitative \& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. |
| Other | Intervention Appropriateness (Relevance) at Community Oncology Sites | Up to 36 months | Outcome will be assessed with mixed methods using qualitative \& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. |
| Other | Intervention Cost at Community Oncology Sites | Up to 36 months | Outcome will be assessed with mixed methods using qualitative \& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. |
| Other | Treatment Fidelity/Adaptation at Community Oncology Sites | Up to 36 months | Outcome will be assessed with mixed methods using qualitative \& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. |
| Other | Intervention Penetration (Reach) at Community Oncology Sites | Up to 36 months | Outcome will be assessed with mixed methods using qualitative \& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. |
| Other | Intervention Sustainability at Community Oncology Sites | Up to 36 months | Outcome will be assessed with mixed methods using qualitative \& quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. |
| Other | Acceptability: Needs Were Met | 6-months | Guided by Proctor and colleagues' (2011) recommendations for measurement of implementation outcomes, we will explore Patient satisfaction with content/delivery of their randomly assigned tobacco treatment (acceptability) to gain an initial understanding of the implementation process. Results of the responses to the "To what extent has the Smoke Free Support Study program met your needs?" acceptability question on the 6-month questionnaire rating from 1 (None of my needs have been met) to 4 (Almost all of my needs have been met) with higher scores indicating more needs met. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03808818/registered