Trial Outcomes & Findings for Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices (NCT NCT03808818)

NCT ID: NCT03808818

Last Updated: 2025-03-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 306 participants
• Primary outcome timeframe: At 6 months
• Results posted on: 2025-03-18

Participant Flow

patients recruited between April 2019 and December 2022

Participant milestones

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Overall Study STARTED	150	156
Overall Study Baseline Survey	150	156
Overall Study 3 Month Survey	110	107
Overall Study 7-day Point Prevalence @3mo (Value or Imputed)	147	154
Overall Study 6 Month Survey	106	99
Overall Study 7-day Point Prevalence @6mo (Value or Imputed)	143	148
Overall Study COMPLETED	106	99
Overall Study NOT COMPLETED	44	57

Reasons for withdrawal

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Overall Study Death	6	6
Overall Study Withdrawal by Subject	7	18
Overall Study Lost to Follow-up	31	33

Baseline Characteristics

Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices

Baseline characteristics by cohort

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=150 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=156 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling	Total n=306 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	57 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	111 Participants n=7 Participants	217 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	142 Participants n=5 Participants	147 Participants n=7 Participants	289 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	129 Participants n=5 Participants	135 Participants n=7 Participants	264 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Living with a smoker Yes	78 Participants n=5 Participants	68 Participants n=7 Participants	146 Participants n=5 Participants
Living with a smoker No	71 Participants n=5 Participants	87 Participants n=7 Participants	158 Participants n=5 Participants
Living with a smoker Not reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 months

Population: Due to COVID-19 restrictions saliva and CO samples could not be collected. Biochemical outcome data is not available for analysis.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 3 months

Population: Due to COVID-19 restrictions saliva and CO samples could not be collected. Biochemical outcome data is not available for analysis.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6 months

Population: 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.

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.

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=143 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=148 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report	21 Participants	42 Participants

SECONDARY outcome

Timeframe: At 3 months

Population: 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.

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.

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=147 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=154 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report	22 Participants	38 Participants

SECONDARY outcome

Timeframe: At 3months and 6 months

Population: 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

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.

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=143 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=148 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Self-reported Continuous Tobacco Abstinence	13 Participants	28 Participants

SECONDARY outcome

Timeframe: At 6 months

Population: Due to COVID-19 restrictions saliva and CO samples could not be collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=143 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=148 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Significant Reduction in Smoking	47 Participants	64 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=147 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=154 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Significant Reduction in Smoking @ 3 Months	53 Participants	57 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=99 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=89 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Acceptability: Needs Were Met Most of my needs have been met	24 Participants	38 Participants
Acceptability: Needs Were Met None of my needs have been met	25 Participants	4 Participants
Acceptability: Needs Were Met Only a few of my needs have been met	37 Participants	9 Participants
Acceptability: Needs Were Met Almost all of my needs have been met	12 Participants	37 Participants
Acceptability: Needs Were Met Skipped question	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-months

Population: Only patients answering the acceptability question are reported

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 "Did you get the kind of smoking cessation assistance that you wanted?" acceptability question on the 6-month questionnaire rating from 1 (No, definitely not) to 4 (Yes, definitely) with higher scores indicating greater confidence that assistance met desired level.

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=99 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=89 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Acceptability: Assistance Support No, definitely not	16 Participants	2 Participants
Acceptability: Assistance Support No, not really	43 Participants	7 Participants
Acceptability: Assistance Support Yes, generally	35 Participants	40 Participants
Acceptability: Assistance Support Yes, definitely	5 Participants	40 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 "How helpful has the Smoke Free Support Study been for you?" acceptability question on the 6-month questionnaire rating from 1 (Not at all helpful) to 5 (Very helpful) with higher scores indicating increased helpfulness.

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=99 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=89 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Acceptability: Helpfulness of Study Not very helpful	17 Participants	1 Participants
Acceptability: Helpfulness of Study Neutral	31 Participants	10 Participants
Acceptability: Helpfulness of Study Somewhat helpful	23 Participants	31 Participants
Acceptability: Helpfulness of Study Very helpful	11 Participants	44 Participants
Acceptability: Helpfulness of Study Not at all helpful	17 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 "How would you rate the quality of the smoking cessation assistance that you received?" acceptability question on the 6-month questionnaire rating from 1 (Poor) to 4 (Excellent) with higher scores indicating more greater quality

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=99 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=89 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Acceptability: Quality of Assistance Did not answer	1 Participants	1 Participants
Acceptability: Quality of Assistance Poor	20 Participants	2 Participants
Acceptability: Quality of Assistance Good	30 Participants	39 Participants
Acceptability: Quality of Assistance Excellent	10 Participants	44 Participants
Acceptability: Quality of Assistance Fair	38 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 "If a friend were in need of similar help, would you recommend the Smoke Free Support Study to him or her?" acceptability question on the 6-month questionnaire Ratings from 1 (No, definitely not) to 4 (Yes, definitely) with higher scores indicating more greater likelihood of recommending.

Outcome measures

Measure	EUC (Smoking Assessment, Quitting Advice, Quitline Referral) n=99 Participants Enhanced usual care (EUC) participants receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	VST (Virtual Counseling Sessions, NRT) n=89 Participants Virtual Sustained Treatment (VST) patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
Acceptability: Would Recommend Study to Friends No, definitely not	3 Participants	1 Participants
Acceptability: Would Recommend Study to Friends No, I don't think so	23 Participants	4 Participants
Acceptability: Would Recommend Study to Friends Yes, I think so	50 Participants	32 Participants
Acceptability: Would Recommend Study to Friends Yes, definitely	19 Participants	51 Participants
Acceptability: Would Recommend Study to Friends Did Not Answer	4 Participants	1 Participants

Adverse Events

Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral)

Serious events: 13 serious events

Other events: 0 other events

Deaths: 13 deaths

Virtual Counseling (Virtual Counseling Sessions, NRT)

Serious events: 10 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Measure	Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) n=150 participants at risk Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation Quality-of-Life Assessment: Ancillary studies	Virtual Counseling (Virtual Counseling Sessions, NRT) n=156 participants at risk Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone). Nicotine Replacement: Given NRT patch or lozenge (or both) Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling
General disorders Death, NOS	4.0% 6/150 • Number of events 6 • from randomization up to 1 year Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)	2.6% 4/156 • Number of events 4 • from randomization up to 1 year Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)
General disorders Other	3.3% 5/150 • Number of events 5 • from randomization up to 1 year Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)	1.3% 2/156 • Number of events 2 • from randomization up to 1 year Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)
Renal and urinary disorders Disease progression	1.3% 2/150 • Number of events 2 • from randomization up to 1 year Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)	1.3% 2/156 • Number of events 2 • from randomization up to 1 year Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)
Cardiac disorders Cardiac Arrest	0.00% 0/150 • from randomization up to 1 year Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)	1.3% 2/156 • Number of events 2 • from randomization up to 1 year Adverse events were only reportable for subjects on the Virtual Intervention arm of the study (ie., those with the possibility of being recommended Nicotine Replacement Therapy from the study team)

Other adverse events

Adverse event data not reported

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: eatrials@jimmy.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60