An interventional study of Standard Care (SC) and Intensive Counseling (IC) in Smoking Cessation, sponsored by Massachusetts General Hospital. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
There are currently over 11 million cancer survivors in the U.S. and survival rates are increasing. Unfortunately, 10-30% of cancer patients are current smokers at the time of diagnosis, and many of these patients have elevated socioeconomic, medical, and psychosocial vulnerabilities. Documented risks associated with continued smoking following cancer diagnosis include decreased survival time; increased complications from surgery, radiation, and chemotherapy; and increased risk of second primary tumors. U.S. Department of Health \& Human Services Public Health Service evidence-based tobacco treatment guidelines exist but have not been integrated into the cancer setting. This is a tremendous missed opportunity to address a modifiable risk factor. In recognition of this treatment gap, the National Cancer Institute (NCI) sponsored a conference in 2009 to address how to increase the readiness and capacity for delivery of tobacco treatment in Cancer Centers. The American Society of Clinical Oncology (ASCO) recommends identification, advice, and counseling of all smokers by their second oncology visit as a core quality indicator; however, currently only half of patients report being asked about tobacco use.
Specific Aim: To conduct a randomized controlled comparative effectiveness trial of two strategies to promote smoking cessation in suspected or newly diagnosed cancer patients.
Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 295 current smokers with suspected or newly diagnosed melanoma, lymphoma, thoracic, breast, genitourinary, gastrointestinal, head and neck, or gynecologic cancer. Participants will be randomly assigned to receive Intensive Counseling (IC) or "Standard Care" (SC). Both groups will receive an initial motivational counseling session and 3 weekly follow-up counseling sessions with a tobacco treatment counselor, conducted in-person or by telephone. The IC arm has the option to also receive:
All participants will complete 1 baseline and 2 follow-up surveys, at 3 and 6 months. Self-reported abstinence will be biochemically confirmed at 3 and 6 months.
Specific Aims
Aim 1: To compare the effectiveness of two tobacco treatments that are integrated into cancer care in producing tobacco abstinence at 6 months.
Aim 2: To explore: a) mechanisms through which treatment promotes abstinence; b) subpopulations in which abstinence is promoted; and c) which aspects of treatment promote abstinence.
Aim 3: To compare the incremental cost effectiveness (cost per quit) of two tobacco treatments.
Exploratory Aim: To identify the percentage and associated characteristics of smokers who 1) enroll in tobacco treatment and 2) adhere to tobacco treatment.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult men and women may participate in this study if he/she meet the following requirements:
[*Patients will be considered "new" and eligible under the following conditions:
EXCLUSION CRITERIA:
In an effort to be as inclusive as possible, a patient will be excluded only if he/she:
ADDITIONAL INFORMATION:
Participant inclusion/exclusion is not based on use of smoking cessation medication -- he/she may decide not to use any smoking cessation medication and still participate in the study. Patients deemed ineligible will be referred to the state quit line.
Patients interested in participating in the study should contact the appropriate contact person, based on whether they are a current patient at the MGH, MSKCC, or DFCI.
Participants randomized to "standard care" (SC) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.
Behavioral: Standard Care (SC)
Participants randomized to intensive counseling (IC) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant.
Behavioral: Intensive Counseling (IC)
1. Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. 2. 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. 3. Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.
Also known as: "Standard of Care" Treatment
The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. 1. Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions. 2. Smoking cessation medication: IC participants will be offered a 4-week supply of FDA-approved smoking cessation medication (varenicline, bupropion or nicotine replacement therapy) of their choice, with the option to renew the medication twice for up to 90 days of free medication. Participants are not required to take smoking cessation medication.
Also known as: Intensive Treatment
Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months
Number of participants with 7-day point-prevalence tobacco abstinence at 6-month follow-up, assessed by biochemically confirmed saliva cotinine (\<15 ng/ml76, 82) or \<10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT
Time frame: 6 months
Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 3 Months
Number of participants with7 -day point-prevalence tobacco abstinence at 3-month follow-up, assessed by biochemically confirmed saliva cotinine (\<15 ng/ml76, 82) or \<10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT
Time frame: 3 months
Number of Participants With Continuous Tobacco Abstinence
Number of Participants with Continuous tobacco abstinence (between quit and follow-up) at 3 \& 6 months
Time frame: 3 months to 6 months
Number of Participants With Sustained Tobacco Abstinence
Number of Participants with Biochemically confirmed repeated point prevalence abstinence at 3 \& 6 months
Time frame: 6 months
Number of Participants With Self-reported 7-day Point Prevalence.
Number of Participants with Self-reported smoking abstinence of at least 7 days
Time frame: 6 months
The Number of IT Participants Who Used Smoking Cessation Pharmacotherapy
The number of IT participants who used 1) smoking cessation pharmacotherapy (Y/N dispensed) 2) smoking cessation counseling (Y/N), 3) 1-2 4-week refills, 4) took 1-3 monthly booster sessions.
Time frame: Treatment Initiation to 6 month follow-up
The Number of IT Participants Who Used Smoking Cessation Counseling
The number of intervention participants who used smoking cessation counseling during the study (Y/N)
Time frame: Treatment Initiation to 6 Month Follow-up
The Number of IT Participants Who Took 1-2 4-week Refills
The number of intervention participants who took 1-2 4-week refills of smoking cessation medication
Time frame: Treatment Initiation to 6 Month Follow-up
The Number of IT Participants Who Took 1-3 Monthly Booster Sessions
The number of IT participants who took 1-3 monthly booster sessions of smoking cessation counseling
Time frame: Treatment Initiation to 6 Month Follow-up
Cost-effectiveness
The cost of the standard of care treatment and the cost of the intensive treatment.
Time frame: 6 months
Between 11/25/2013 and 7/1/2017 4709 patients were screened for eligibility. 2659 were eligible based on screen criteria; 1808 did not complete the screen. Of the 851 who were approached to complete the screen, 405 were ineligible, 303 enrolled and were randomized, and 143 refused (84 refused consent and 59 did not complete the baseline survey)
| Milestone | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| Started | 150 | 153 |
| Completed | 150 | 153 |
| Not completed | 0 | 0 |
Number of participants with 7-day point-prevalence tobacco abstinence at 6-month follow-up, assessed by biochemically confirmed saliva cotinine (\<15 ng/ml76, 82) or \<10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT
| Participants | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months | 29 | 51 |
Number of participants with7 -day point-prevalence tobacco abstinence at 3-month follow-up, assessed by biochemically confirmed saliva cotinine (\<15 ng/ml76, 82) or \<10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT
| Participants | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 3 Months | 28 | 46 |
Number of Participants with Continuous tobacco abstinence (between quit and follow-up) at 3 \& 6 months
| Participants | Standard Treatment | Intensive Treatment) |
|---|---|---|
| Number of Participants With Continuous Tobacco Abstinence | 26 | 43 |
Number of Participants with Biochemically confirmed repeated point prevalence abstinence at 3 \& 6 months
| Participants | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| Number of Participants With Sustained Tobacco Abstinence | 17 | 35 |
Number of Participants with Self-reported smoking abstinence of at least 7 days
| Participants | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| Number of Participants With Self-reported 7-day Point Prevalence. | 42 | 54 |
The number of IT participants who used 1) smoking cessation pharmacotherapy (Y/N dispensed) 2) smoking cessation counseling (Y/N), 3) 1-2 4-week refills, 4) took 1-3 monthly booster sessions.
| Participants | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| The Number of IT Participants Who Used Smoking Cessation Pharmacotherapy | — | 122 |
The number of intervention participants who used smoking cessation counseling during the study (Y/N)
| Participants | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| The Number of IT Participants Who Used Smoking Cessation Counseling | — | 153 |
The number of intervention participants who took 1-2 4-week refills of smoking cessation medication
| Participants | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| The Number of IT Participants Who Took 1-2 4-week Refills | — | 87 |
The number of IT participants who took 1-3 monthly booster sessions of smoking cessation counseling
| Participants | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| The Number of IT Participants Who Took 1-3 Monthly Booster Sessions | — | 99 |
The cost of the standard of care treatment and the cost of the intensive treatment.
| dollars | Standard Treatment (ST) | Intensive Treatment |
|---|---|---|
| Cost-effectiveness | 638 (570 to 710) | 1144 (1061 to 1231) |
Collected over Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Treatment (ST) | 9/150 (6%) | 0/150 (0%) | 17/150 (11.3%) |
| Intensive Treatment (IT) | 4/153 (2.6%) | 0/153 (0%) | 41/153 (26.8%) |
| Event | Standard Treatment (ST) | Intensive Treatment (IT) |
|---|---|---|
| NauseaGeneral disorders | 6/150 | 13/153 |
| RashGeneral disorders | 1/150 | 4/153 |
| Mouth irritationGeneral disorders | 0/150 | 4/153 |
| HiccupsGeneral disorders | 1/150 | 3/153 |
| Difficulty sleepingGeneral disorders | 2/150 | 3/153 |
| Vivid dreamsGeneral disorders | 2/150 | 3/153 |
| HeadacheGeneral disorders | 2/150 | 1/153 |
| SIADHGeneral disorders | 0/150 | 2/153 |
| FlatulenceGeneral disorders | 1/150 | 1/153 |
| HeartburnGeneral disorders | 1/150 | 0/153 |
| Age, Continuous(years) | Standard Treatment (ST) | Intensive Treatment (IT) | Total |
|---|---|---|---|
| Mean | 58 ± 9.5 | 58 ± 9.9 | 58 ± 9.7 |
| Sex: Female, Male(Participants) | Standard Treatment (ST) | Intensive Treatment (IT) | Total |
|---|---|---|---|
| Female | 83 | 87 | 170 |
| Male | 67 | 66 | 133 |
| Ethnicity (NIH/OMB)(Participants) | Standard Treatment (ST) | Intensive Treatment (IT) | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 7 | 11 |
| Not Hispanic or Latino | 146 | 146 | 292 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Standard Treatment (ST) | Intensive Treatment (IT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 17 | 14 | 31 |
| White | 131 | 134 | 265 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Region of Enrollment(participants) | Standard Treatment (ST) | Intensive Treatment (IT) | Total |
|---|---|---|---|
| United States | 150 | 153 | 303 |
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