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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA166147-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care (SC) | Experimental | Participants randomized to "standard care" (SC) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. |
|
| Intensive Counseling (IC) | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care (SC) | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
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INCLUSION CRITERIA:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Elyse R Park, Ph.D., MPH | Massachusetts General Hospital | Principal Investigator |
| Jamie S. Ostroff, Ph.D. | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33048154 | Derived | Park ER, Perez GK, Regan S, Muzikansky A, Levy DE, Temel JS, Rigotti NA, Pirl WF, Irwin KE, Partridge AH, Cooley ME, Friedman ER, Rabin J, Ponzani C, Hyland KA, Holland S, Borderud S, Sprunck K, Kwon D, Peterson L, Miller-Sobel J, Gonzalez I, Whitlock CW, Malloy L, de Leon-Sanchez S, O'Brien M, Ostroff JS. Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial. JAMA. 2020 Oct 13;324(14):1406-1418. doi: 10.1001/jama.2020.14581. | |
| 27444428 |
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Of the 446 eligible for the study, 303 were randomized, 84 were eligible but refused consent (top 3 reasons: too upset, did not need help, had no time) and 59 were eligible but were not randomized because they did not complete a baseline survey.
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)
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment (ST) | Participants randomized to "standard treatment" will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (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. |
| FG001 | Intensive Treatment (IT) | Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the ST arm. IT participants have the option to also receive:
Intensive Treatment (IT): The IT model includes all components of the ST as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment (ST) | Participants randomized to "standard treatment" will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (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: ST 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment. | Posted | Count of Participants | Participants | 6 months |
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Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up.
Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. *Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Treatment (ST) | Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment | General nausea, nausea and upset stomach, nausea and vomiting, nausea and increased heart rate related to smoking cessation medication use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor | Elyse Park | 617-724-6836 | epark@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2016 | Jun 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Intensive Counseling (IC) | Behavioral | 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.
|
|
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| Number of Participants With Continuous Tobacco Abstinence | Number of Participants with Continuous tobacco abstinence (between quit and follow-up) at 3 & 6 months | 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 | 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 | 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. | 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) | 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 | 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 | Treatment Initiation to 6 Month Follow-up |
| Cost-effectiveness | The cost of the standard of care treatment and the cost of the intensive treatment. | 6 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Derived |
| Park ER, Ostroff JS, Perez GK, Hyland KA, Rigotti NA, Borderud S, Regan S, Muzikansky A, Friedman ER, Levy DE, Holland S, Eusebio J, Peterson L, Rabin J, Miller-Sobel J, Gonzalez I, Malloy L, O'Brien M, de Leon-Sanchez S, Whitlock CW. Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial. Contemp Clin Trials. 2016 Sep;50:54-65. doi: 10.1016/j.cct.2016.07.016. Epub 2016 Jul 19. |
| BG001 | Intensive Treatment (IT) | Participants randomized to intensive treatment (IT) 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:
Intensive Counseling: The IT model includes all components of the ST as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Intensive Treatment (IT) | Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive:
Intensive Counseling (IC): 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. |
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| Secondary | 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 | Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Number of Participants With Continuous Tobacco Abstinence | Number of Participants with Continuous tobacco abstinence (between quit and follow-up) at 3 & 6 months | Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment. | Posted | Count of Participants | Participants | 3 months to 6 months |
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|
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| Secondary | Number of Participants With Sustained Tobacco Abstinence | Number of Participants with Biochemically confirmed repeated point prevalence abstinence at 3 & 6 months | Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants With Self-reported 7-day Point Prevalence. | Number of Participants with Self-reported smoking abstinence of at least 7 days | Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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. | Only assessed intensive treatment arm. | Posted | Count of Participants | Participants | Treatment Initiation to 6 month follow-up |
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| Secondary | 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) | Only assessed intensive treatment arm | Posted | Count of Participants | Participants | Treatment Initiation to 6 Month Follow-up |
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| Secondary | 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 | Only assessed intensive treatment arm | Posted | Count of Participants | Participants | Treatment Initiation to 6 Month Follow-up |
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| Secondary | 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 | Only assessed intensive treatment arm | Posted | Count of Participants | Participants | Treatment Initiation to 6 Month Follow-up |
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| Secondary | Cost-effectiveness | The cost of the standard of care treatment and the cost of the intensive treatment. | Cost per quit (in dollars) are shown below. | Posted | Mean | 95% Confidence Interval | dollars | 6 months |
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| 9 |
| 150 |
| 0 |
| 150 |
| 17 |
| 150 |
| EG001 | Intensive Treatment (IT) | Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive:
I | 4 | 153 | 0 | 153 | 41 | 153 |
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| Rash | General disorders | Systematic Assessment | Rash related to smoking cessation medication |
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| Hiccups | General disorders | Systematic Assessment | Hiccups related to use of smoking cessation medication |
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| SIADH | General disorders | Systematic Assessment | SIADH reaction to smoking cessation medication use |
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| Bad taste in mouth | General disorders | Systematic Assessment | Bad taste in mouth related to smoking cessation medication |
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| Flatulence | General disorders | Systematic Assessment | Flatulence related to smoking cessation medication |
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| Mouth irritation | General disorders | Systematic Assessment | Mouth irritation, burning sensation in mouth, tingling sensation on tongue related to smoking cessation medication |
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| Difficulty sleeping | General disorders | Systematic Assessment | Difficulty sleeping related to smoking cessation medication |
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| Fatigue | General disorders | Systematic Assessment | Fatigue or fog-headedness related to smoking cessation medication |
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| Chest discomfort | General disorders | Systematic Assessment | Chest discomfort or palpitations related to smoking cessation medication |
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| Pain in lower back and leg | General disorders | Systematic Assessment | Pain in lower back and leg related to smoking cessation medication |
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| Headache | General disorders | Systematic Assessment | Headache and headache with diarrhea related to smoking cessation medication |
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| Heartburn | General disorders | Systematic Assessment | Heartburn related to smoking cessation medication |
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| Lightheadedness | General disorders | Systematic Assessment | Lightheadedness related to smoking cessation medication |
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| Swollen ankles | General disorders | Systematic Assessment | Swollen ankles related to smoking cessation medication |
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| Vivid dreams | General disorders | Systematic Assessment | Vivid dreams related to smoking cessation medication |
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| Malaise | General disorders | Systematic Assessment | Malaise related to smoking cessation medication |
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| Shortness of breath | General disorders | Systematic Assessment | Shortness of breath related to smoking cessation medication |
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