Carcinoma In Situ, Current Smoker, Malignant Neoplasm, Primary Neoplasm, Recurrent Neoplasm, Smoking Cessation
Conditions
Brief summary
This phase II trial studies how well smoking cessation treatment plans work in tobacco-dependent cancer patients when delivered virtually as part of their cancer care in community oncology practices. Virtual information and counseling sessions may help cancer patients quit smoking.
Detailed description
PRIMARY OBJECTIVE: I. To compare the proportions of participants in the Enhanced Usual Care (EUC) and Virtual Tobacco Treatment (VIT) study arms with biochemically-verified 7-day point-prevalence abstinence from cigarettes at 6-months post enrollment. SECONDARY OBJECTIVES: I. Biochemically-verified 7-day point prevalence abstinence at 3-months follow-up. II. Self-reported 7-day point prevalence cigarette abstinence at 3- and 6-months follow-up. III. Significant reduction (\> 50% reduction in reported number of cigarettes per day) in daily smoking from baseline to 3- and baseline to 6-months follow-up. IV. Continuous (no self-reported smoking since last survey point) and sustained abstinence at 6 months (cotinine-verified at 3-months and 6-months). EXPLORATORY OBJECTIVES: I. To assess the potential effect of known and potential moderators on treatment effectiveness between the two arms. II. To assess the processes of implementation and dissemination (acceptability, adoption, appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and sustainability) of the investigator's intervention at community oncology sites. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A (Enhanced Usual Care \[EUC\]): Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the National Cancer Institute (NCI) Smoking Quitline. ARM B (Virtual Intervention Treatment \[VIT\]): 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 nicotine replacement (NRT) (patch and lozenge combined or alone). After completion of study, patients may be followed up for 1 year.
Interventions
Receive information about tobacco cessation
Given NRT patch or lozenge (or both)
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Receive virtual tobacco cessation counseling
Sponsors
National Cancer Institute (NCI)
ECOG-ACRIN Cancer Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* STAFF ELIGIBILITY CRITERIA: * Must be English speaking. * Must be employed at NCI Community Oncology Research Program (NCORP) site for at least three months. * PATIENT ELIGIBILITY CRITERIA STEP 0: * Patient presenting with any type of cancer with a date of diagnosis within the past 4 months. Recurrence, diagnosed within the last 4 months, of tumors in patients with past cancer diagnoses will be considered eligible. Patients with a new primary cancer, diagnosed within the last 4 months, who have been treated previously for other types of cancer will also be considered eligible. ?In situ? cancers, diagnosed within the past 4 months, will also be considered eligible. * Patient must be a current smoker. Current smoker is defined as any cigarette smoking (even a puff) in the past 30 days. * Patient must be fluent in both, written and spoken, English or both, written and spoken, Spanish. * Patient must have telephone, e-mail access, and have access to the internet with a camera-enabled device (e.g., smartphone, tablet, computer, laptop with a webcam/camera) * NOTE: The restriction to those with web and e-mail access is based on the primary intention of the study; to assess the implementation of the virtual intervention in the NCORP network. * ELIGIBILITY CRITERIA STEP 1: Patient must still meet all criteria outlined in step 0. * ELIGIBILITY STEP 2 (RANDOMIZATION): Patient must have completed baseline survey in Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group Systems for Easy Entry of Patient Reported Outcomes (EASEEPRO) within 1 month (30 days) of the date of informed consent (Step 1).
Exclusion criteria
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above, or is deemed medically unable to participate by study investigators or oncology clinician (i.e., referral to hospice). * Patient has no intention to receive their cancer care or monitoring at an NCORP community cancer site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Acceptability: Helpfulness of Study | 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. |
| Acceptability: Quality of Assistance | 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 |
| Acceptability: Would Recommend Study to Friends | 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. |
| Acceptability: Assistance Support | 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 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
patients recruited between April 2019 and December 2022
Participants by arm
| Arm | Count |
|---|---|
| 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 | 150 |
| 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
Survey Administration: Ancillary studies
Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling | 156 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 6 |
| Overall Study | Lost to Follow-up | 31 | 33 |
| Overall Study | Withdrawal by Subject | 7 | 18 |
Baseline characteristics
| Characteristic | EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | VST (Virtual Counseling Sessions, NRT) | Total |
|---|---|---|---|
| Age, Continuous | 57 years | 57 years | 57 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 142 Participants | 147 Participants | 289 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 2 Participants | 8 Participants |
| Living with a smoker No | 71 Participants | 87 Participants | 158 Participants |
| Living with a smoker Not reported | 1 Participants | 1 Participants | 2 Participants |
| Living with a smoker Yes | 78 Participants | 68 Participants | 146 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 12 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) White | 129 Participants | 135 Participants | 264 Participants |
| Sex: Female, Male Female | 106 Participants | 111 Participants | 217 Participants |
| Sex: Female, Male Male | 44 Participants | 45 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 150 | 10 / 156 |
| other Total, other adverse events | 0 / 150 | 0 / 156 |
| serious Total, serious adverse events | 13 / 150 | 10 / 156 |
Outcome results
Primary
Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)
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.
Time frame: 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.
Secondary
7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report | 22 Participants |
| VST (Virtual Counseling Sessions, NRT) | 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report | 38 Participants |
Comparison: 7-day point prevalence abstinence at 3-months, with a sample size of 140 in each arm then smallest detectable difference will be 18% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 20%p-value: 0.03595% CI: [1.04, 3.33]Chi-squared
Secondary
7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report | 21 Participants |
| VST (Virtual Counseling Sessions, NRT) | 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report | 42 Participants |
Comparison: For self-reported 7-day point prevalence abstinence at 6-months, with a sample size of 140 in each arm then smallest detectable difference will be 22% with 80% power. Subsequent analyses will use a Bonferroni corrected alpha of 0.002 using with an estimated control rate of 31%.~The primary analysis will be performed from an intent-to-treat perspective. Chi-square tests will be used to compare the outcomes between treatment groups.p-value: 0.004695% CI: [1.28, 4.13]Chi-squared
Secondary
Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated)
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.
Time frame: 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.
Secondary
Self-reported Continuous Tobacco Abstinence
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Self-reported Continuous Tobacco Abstinence | 13 Participants |
| VST (Virtual Counseling Sessions, NRT) | Self-reported Continuous Tobacco Abstinence | 28 Participants |
Comparison: power calculations assumed a sample size of 140 in each arm and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%p-value: 0.016Chi-squared
Secondary
Significant Reduction in Smoking
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
Time frame: baseline and 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Significant Reduction in Smoking | 47 Participants |
| VST (Virtual Counseling Sessions, NRT) | Significant Reduction in Smoking | 64 Participants |
p-value: 0.069Chi-squared
Secondary
Significant Reduction in Smoking @ 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
Time frame: baseline and 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Significant Reduction in Smoking @ 3 Months | 53 Participants |
| VST (Virtual Counseling Sessions, NRT) | Significant Reduction in Smoking @ 3 Months | 57 Participants |
p-value: 0.86Chi-squared
Secondary
Sustained Tobacco Abstinence at 6 Months (Not Evaluated)
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.
Time frame: At 6 months
Population: Due to COVID-19 restrictions saliva and CO samples could not be collected
Other Pre-specified
Acceptability: Assistance Support
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.
Time frame: 6-months
Population: Only patients answering the acceptability question are reported
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Assistance Support | No, definitely not | 16 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Assistance Support | No, not really | 43 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Assistance Support | Yes, generally | 35 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Assistance Support | Yes, definitely | 5 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Assistance Support | Yes, definitely | 40 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Assistance Support | No, definitely not | 2 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Assistance Support | Yes, generally | 40 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Assistance Support | No, not really | 7 Participants |
Comparison: Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.p-value: <0.0001Fisher Exact
Other Pre-specified
Acceptability: Helpfulness of Study
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.
Time frame: 6-months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Helpfulness of Study | Not very helpful | 17 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Helpfulness of Study | Somewhat helpful | 23 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Helpfulness of Study | Neutral | 31 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Helpfulness of Study | Very helpful | 11 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Helpfulness of Study | Not at all helpful | 17 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Helpfulness of Study | Very helpful | 44 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Helpfulness of Study | Not at all helpful | 3 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Helpfulness of Study | Not very helpful | 1 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Helpfulness of Study | Neutral | 10 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Helpfulness of Study | Somewhat helpful | 31 Participants |
Comparison: Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.p-value: <0.0001Fisher Exact
Other Pre-specified
Acceptability: Needs Were Met
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.
Time frame: 6-months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Needs Were Met | Only a few of my needs have been met | 37 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Needs Were Met | Almost all of my needs have been met | 12 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Needs Were Met | Most of my needs have been met | 24 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Needs Were Met | Skipped question | 1 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Needs Were Met | None of my needs have been met | 25 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Needs Were Met | Skipped question | 1 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Needs Were Met | None of my needs have been met | 4 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Needs Were Met | Only a few of my needs have been met | 9 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Needs Were Met | Most of my needs have been met | 38 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Needs Were Met | Almost all of my needs have been met | 37 Participants |
Comparison: Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.p-value: <0.0001Fisher Exact
Other Pre-specified
Acceptability: Quality of Assistance
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
Time frame: 6-months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Quality of Assistance | Poor | 20 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Quality of Assistance | Good | 30 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Quality of Assistance | Fair | 38 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Quality of Assistance | Excellent | 10 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Quality of Assistance | Did not answer | 1 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Quality of Assistance | Excellent | 44 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Quality of Assistance | Did not answer | 1 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Quality of Assistance | Poor | 2 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Quality of Assistance | Fair | 3 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Quality of Assistance | Good | 39 Participants |
Other Pre-specified
Acceptability: Would Recommend Study to Friends
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.
Time frame: 6-months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Would Recommend Study to Friends | No, I don't think so | 23 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Would Recommend Study to Friends | Yes, definitely | 19 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Would Recommend Study to Friends | Yes, I think so | 50 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Would Recommend Study to Friends | Did Not Answer | 4 Participants |
| EUC (Smoking Assessment, Quitting Advice, Quitline Referral) | Acceptability: Would Recommend Study to Friends | No, definitely not | 3 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Would Recommend Study to Friends | Did Not Answer | 1 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Would Recommend Study to Friends | No, definitely not | 1 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Would Recommend Study to Friends | No, I don't think so | 4 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Would Recommend Study to Friends | Yes, I think so | 32 Participants |
| VST (Virtual Counseling Sessions, NRT) | Acceptability: Would Recommend Study to Friends | Yes, definitely | 51 Participants |
Comparison: Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.p-value: <0.0001Fisher Exact
Other Pre-specified
Implementation of the Intervention at Community Oncology Sites
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).
Time frame: Up to 36 months
Other Pre-specified
Intervention Acceptability (Satisfaction With Content/Delivery) at Community Oncology Sites
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.
Time frame: Up to 36 months
Other Pre-specified
Intervention Adoption (Program Uptake) at Community Oncology Sites
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.
Time frame: Up to 36 months
Other Pre-specified
Intervention Appropriateness (Relevance) at Community Oncology Sites
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.
Time frame: Up to 36 months
Other Pre-specified
Intervention Cost at Community Oncology Sites
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.
Time frame: Up to 36 months
Other Pre-specified
Intervention Penetration (Reach) at Community Oncology Sites
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.
Time frame: Up to 36 months
Other Pre-specified
Intervention Sustainability at Community Oncology Sites
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.
Time frame: Up to 36 months
Other Pre-specified
Potential Effect of Cancer Variables on Treatment Effectiveness
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.
Time frame: Up to 6 months
Other Pre-specified
Potential Effect of Medical and Smoking History on Treatment Effectiveness
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.
Time frame: Up to 6 months
Other Pre-specified
Potential Effect of Sociodemographics on Treatment Effectiveness
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.
Time frame: Up to 6 months
Other Pre-specified
Treatment Fidelity/Adaptation at Community Oncology Sites
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.
Time frame: Up to 36 months