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.
Brief Title
Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Carcinoma In Situ
Current Smoker
Malignant Neoplasm
Primary Neoplasm
Recurrent Neoplasm
Smoking Cessation
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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).
* 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).
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03808818
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
EAQ171CD
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"
Primary Outcomes
Outcome Description
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.
COVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.
Outcome Measure
Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)
Outcome Time Frame
At 6 months
Secondary Ids
Secondary Id
NCI-2018-02826
Secondary Id
EAQ171CD
Secondary Id
ECOG-ACRIN-EAQ171CD
Secondary Id
EAQ171CD
Secondary Id
R01CA214427
Secondary Outcomes
Outcome Description
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.
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 Time Frame
At 3 months
Outcome Measure
Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated)
Outcome Description
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 Time Frame
At 6 months
Outcome Measure
7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report
Outcome Description
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 Time Frame
At 3 months
Outcome Measure
7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report
Outcome Description
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.
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 Time Frame
At 3months and 6 months
Outcome Measure
Self-reported Continuous Tobacco Abstinence
Outcome Description
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.
COVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.
Outcome Time Frame
At 6 months
Outcome Measure
Sustained Tobacco Abstinence at 6 Months (Not Evaluated)
Outcome Description
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
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 Time Frame
baseline and 6 months
Outcome Measure
Significant Reduction in Smoking
Outcome Description
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
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 Time Frame
baseline and 3 months
Outcome Measure
Significant Reduction in Smoking @ 3 Months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Bruce Rapkin
Investigator Email
bruce.rapkin@einsteinmed.org
Investigator Phone
718-920-5663