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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016056 | U.S. NIH Grant/Contract | View source | |
| RPCI-I-118207 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and nicotine replacement therapy may be useful in helping smokers stop smoking.
PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to cigarettes.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Participants undergo a 10-15 minute web-based survey on a computer in the Tobacco Research Laboratory to assess basic demographic information; beliefs about the relative harmfulness of nicotine replacement (NR) and smokeless (SL) products, including use of relevant questions from the International Tobacco Control (ITC) 4 country survey; past experiences with NR and SL products and perceptions about them; and willingness to try samples of NR/SL products they have not previously used, or, if not willing, reasons for refusal. Participants also receive an information sheet while simultaneously hearing an audio recording of it.
Participants complete questionnaires at 2, 3, and 4 weeks.
Beginning 2 weeks after study intervention, some participants receive a day's supply of ≤ 4 smokeless tobacco or nicotine products and periodically undergo a breath CO and saliva and buccal cell sample collection. Surveys are completed and samples collected at 3 and 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall | Other | Single-armed study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telephone-based intervention | Behavioral | 10-15 minute web-based survey on a computer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs) | Baseline | |
| Number of Participants Willing to Try HRPs | Baseline | |
| Number of Participants That Completed 1-week Trial | One week | |
| Number of Participants Willing to Continue With Preferred HRP | 1 week follow up |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Mahoney, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Noncombusted Nicotine Product With Informational Intervention | Single-armed study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| nicotine replacement therapy |
| Drug |
One week supply |
|
| informational intervention | Other |
|
| internet-based intervention | Other |
|
| questionnaire administration | Other | Given out week 2, 3 and 4. |
|
| Follow-up #1 |
|
| Follow-up #2 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Current smokers, aged 18+, smoke at least 10 cigarettes per day, not planning to quit smoking in the next 30 days
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Single-armed study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 no Interest in Trial of Harm-reduction Products (HRPs) | Posted | Number | participants | Baseline |
|
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| Primary | Number of Participants Willing to Try HRPs | Posted | Number | participants | Baseline |
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| ||||||||||||||||||||||||||||
| Primary | Number of Participants That Completed 1-week Trial | Posted | Number | participants | One week |
|
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| ||||||||||||||||||||||||||||
| Primary | Number of Participants Willing to Continue With Preferred HRP | Those who completed one-week multiple product sampling | Posted | Number | participants | 1 week follow up |
|
|
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Collected over 2 weeks while participants were using tobacco products
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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 | Overall | Single-armed study | 0 | 59 | 0 | 59 |
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About 1/3 of initial participants did not complete this study. The limited number of participants precludes identifying demographic predictors of willingness or patterns of substitution. Single armed study lacks comparison group.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard O'Connor | Roswell Park Cancer Institute | 716-845-4517 | richard.oconnor@roswellpark.org |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D007680 | Kidney Neoplasms |
| D007938 | Leukemia |
| D008113 | Liver Neoplasms |
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D014029 | Tobacco Use Disorder |
| D002292 | Carcinoma, Renal Cell |
| D006528 | Carcinoma, Hepatocellular |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007674 | Kidney Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008107 | Liver Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D009059 | Mouth Diseases |
| D009302 | Nasopharyngeal Diseases |
| D007951 | Leukemia, Myeloid |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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