Trial · NCT03808818
Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
NCT03808818, Not applicable, Completed, ECOG-ACRIN Cancer Research Group; results first posted 2025-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices. Trials, record NCT03808818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03808818
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
- NCT number
- NCT03808818
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 306 participants, actual
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
- Carcinoma In Situ, Current Smoker, Malignant Neoplasm, Primary Neoplasm, Recurrent Neoplasm, Smoking Cessation
- Interventions
- Behavioral, Psychological or Informational Intervention, Nicotine Replacement, Quality-of-Life Assessment, Survey Administration, Tobacco Cessation Counseling
- First posted
- 2019-01-18
- Last updated
- 2025-03-18
- Results first posted
- 2025-03-18
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated) | At 6 months | Due to COVID-19 restrictions saliva and CO samples could not be collected. Biochemical outcome data is not available for analysis. | ||
| SECONDARY | Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated) | At 3 months | Due to COVID-19 restrictions saliva and CO samples could not be collected. Biochemical outcome data is not available for analysis. | ||
| SECONDARY | 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report | At 6 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report | At 3 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Self-reported Continuous Tobacco Abstinence | At 3months and 6 months | If participants withdrew or did not answer the survey at the specified timepoint, they were marked as having recently smoked Analysis only includes participants having a result for the 6-month timepoint | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sustained Tobacco Abstinence at 6 Months (Not Evaluated) | At 6 months | Due to COVID-19 restrictions saliva and CO samples could not be collected | ||
| SECONDARY | Significant Reduction in Smoking | baseline and 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Significant Reduction in Smoking @ 3 Months | baseline and 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Potential Effect of Sociodemographics on Treatment Effectiveness | Up to 6 months | |||
| OTHER_PRE_SPECIFIED | Potential Effect of Medical and Smoking History on Treatment Effectiveness | Up to 6 months |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 21 | Participants | ||
| 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report | VST (Virtual Counseling Sessions, NRT) | 42 | Participants | ||
| 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 22 | Participants | ||
| 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report | VST (Virtual Counseling Sessions, NRT) | 38 | Participants | ||
| Self-reported Continuous Tobacco Abstinence | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 13 | Participants | ||
| Self-reported Continuous Tobacco Abstinence | VST (Virtual Counseling Sessions, NRT) | 28 | Participants | ||
| Significant Reduction in Smoking | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 47 | Participants | ||
| Significant Reduction in Smoking | VST (Virtual Counseling Sessions, NRT) | 64 | Participants | ||
| Significant Reduction in Smoking @ 3 Months | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 53 | Participants | ||
| Significant Reduction in Smoking @ 3 Months | VST (Virtual Counseling Sessions, NRT) | 57 | Participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 150 | |
| Overall Study | STARTED | VST (Virtual Counseling Sessions, NRT) | 156 | |
| Overall Study | Baseline Survey | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 150 | |
| Overall Study | Baseline Survey | VST (Virtual Counseling Sessions, NRT) | 156 | |
| Overall Study | 3 Month Survey | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 110 | |
| Overall Study | 3 Month Survey | VST (Virtual Counseling Sessions, NRT) | 107 | |
| Overall Study | 7-day Point Prevalence @3mo (Value or Imputed) | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 147 | |
| Overall Study | 7-day Point Prevalence @3mo (Value or Imputed) | VST (Virtual Counseling Sessions, NRT) | 154 | |
| Overall Study | 6 Month Survey | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 106 | |
| Overall Study | 6 Month Survey | VST (Virtual Counseling Sessions, NRT) | 99 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Death, NOS | General disorders | Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) | 6 | 150 | 6 |
| serious | Death, NOS | General disorders | Virtual Counseling (Virtual Counseling Sessions, NRT) | 4 | 156 | 4 |
| serious | Other | General disorders | Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) | 5 | 150 | 5 |
| serious | Other | General disorders | Virtual Counseling (Virtual Counseling Sessions, NRT) | 2 | 156 | 2 |
| serious | Disease progression | Renal and urinary disorders | Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) | 2 | 150 | 2 |
| serious | Disease progression | Renal and urinary disorders | Virtual Counseling (Virtual Counseling Sessions, NRT) | 2 | 156 | 2 |
| serious | Cardiac Arrest | Cardiac disorders | Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) | 0 | 150 | 0 |
| serious | Cardiac Arrest | Cardiac disorders | Virtual Counseling (Virtual Counseling Sessions, NRT) | 2 | 156 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) | 13 | 150 |
| Total, all-cause mortality | Virtual Counseling (Virtual Counseling Sessions, NRT) | 10 | 156 |
| Total, other adverse events | Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) | 0 | 150 |
| Total, other adverse events | Virtual Counseling (Virtual Counseling Sessions, NRT) | 0 | 156 |
| Total, serious adverse events | Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) | 13 | 150 |
| Total, serious adverse events | Virtual Counseling (Virtual Counseling Sessions, NRT) | 10 | 156 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA214427 | Implementing A Virtual Tobacco Treatment in Community Oncology Practices | PARK, ELYSE R.; OSTROFF, JAMIE S. | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL CANCER INSTITUTE | 2018 to 2023 |
Source NIH RePORTER
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) vs VST (Virtual Counseling Sessions, NRT): Significant Reduction in Smoking @ 3 Months | Trial comparisons |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) vs VST (Virtual Counseling Sessions, NRT): Significant Reduction in Smoking | Trial comparisons |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) vs VST (Virtual Counseling Sessions, NRT): 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report | Trial comparisons |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) vs VST (Virtual Counseling Sessions, NRT): 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report | Trial comparisons |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) vs VST (Virtual Counseling Sessions, NRT): Self-reported Continuous Tobacco Abstinence | Trial comparisons |
| Virtual Counseling (Virtual Counseling Sessions, NRT) vs Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral): deaths from any cause | Trial comparisons |
| Virtual Counseling (Virtual Counseling Sessions, NRT) vs Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03808818
GET https://conductscience.org/api/trials/v1/NCT03808818/registered?page=2