Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder
Conditions
Keywords
tobacco use disorder, bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, non-small cell lung cancer, small cell lung cancer, pancreatic cancer, hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, adult acute myeloid leukemia
Brief summary
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.
Detailed description
OBJECTIVES: Primary * To assess the impact of factual information (a fact sheet) about the relative harms of smokeless (SL)/nicotine replacement (NR) products on participants' beliefs about relative harmfulness. * To assess the impact of trying samples of NR and/or SL products on intentions to use such products as alternatives to cigarettes. Secondary * To explore the effects of factual information in regard to smoked tobacco on smokers' intentions to use such products as alternatives to cigarettes. * To assess potential barriers to use of both NR and SL products as substitutes for cigarettes. * To obtain estimates of possible effect sizes for powering a proposed comprehensive test of the likely outcomes of using these products in preference to cigarettes (and other smoked products). 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.
Interventions
BEHAVIORALtelephone-based intervention
10-15 minute web-based survey on a computer
DRUGnicotine replacement therapy
One week supply
OTHERinformational intervention
OTHERinternet-based intervention
OTHERquestionnaire administration
Given out week 2, 3 and 4.
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Currently smokes ≥ 10 cigarettes per day * Not planning to quit smoking in the next 30 days and has not tried to quit in the past 30 days * Medically eligible to receive nicotine-replacement products, based on the NYS Smokers Quitline eligibility criteria PATIENT CHARACTERISTICS: * Not pregnant or nursing * Able to read and speak English * In good general health * No history of heart attack or stroke in the past 2 weeks * No history of chest pains in the past month * No report of physician-diagnosed arrhythmia/irregular heartbeat or use of pacemaker * No report of physician-diagnosed heart disease/coronary artery disease, uncontrolled hypertension, stomach ulcer, diabetes, depression, or asthma PRIOR CONCURRENT THERAPY: * No other concurrent tobacco products or nicotine medications * No concurrent Zyban, Bupropion, Wellbutrin, Chantix, or other smoking cessation medication
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Single-armed study | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 9.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Gender Female | 35 Participants |
| Gender Male | 32 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Region of Enrollment United States | 67 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 |
Outcome results
Primary
Number of Participants That Completed 1-week Trial
Time frame: One week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | Number of Participants That Completed 1-week Trial | 50 participants |
Primary
Number of Participants Willing to Continue With Preferred HRP
Time frame: 1 week follow up
Population: Those who completed one-week multiple product sampling
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | Number of Participants Willing to Continue With Preferred HRP | 49 participants |
Primary
Number of Participants Willing to Try HRPs
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | Number of Participants Willing to Try HRPs | 60 participants |
Primary
Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs) | 7 participants |