An interventional study of telephone-based intervention and nicotine replacement therapy in Bladder Cancer, Cervical Cancer and Esophageal Cancer, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-02-07.
Sponsored by Roswell Park Cancer Institute · Not applicable and Interventional
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 67 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Single-armed study
Behavioral: telephone-based intervention · Drug: nicotine replacement therapy · Other: informational intervention · Other: internet-based intervention · Other: questionnaire administration
10-15 minute web-based survey on a computer
One week supply
Given out week 2, 3 and 4.
Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)
Time frame: Baseline
Number of Participants Willing to Try HRPs
Time frame: Baseline
Number of Participants That Completed 1-week Trial
Time frame: One week
Number of Participants Willing to Continue With Preferred HRP
Time frame: 1 week follow up
| Milestone | Noncombusted Nicotine Product With Informational Intervention |
|---|---|
| Started | 67 |
| Follow-up #1 | 59 |
| Follow-up #2 | 50 |
| Completed | 44 |
| Not completed | 23 |
| Withdrew: Lost to follow-up | 19 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Withdrawal by subject | 1 |
| participants | Overall |
|---|---|
| Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs) | 7 |
| participants | Overall |
|---|---|
| Number of Participants Willing to Try HRPs | 60 |
| participants | Overall |
|---|---|
| Number of Participants That Completed 1-week Trial | 50 |
| participants | Overall |
|---|---|
| Number of Participants Willing to Continue With Preferred HRP | 49 |
Collected over Collected over 2 weeks while participants were using tobacco products. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall | — | 0/59 (0%) | 0/59 (0%) |
Current smokers, aged 18+, smoke at least 10 cigarettes per day, not planning to quit smoking in the next 30 days
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 46.7 ± 9.59 |
| Gender(Participants) | Overall |
|---|---|
| Female | 35 |
| Male | 32 |
| Ethnicity (NIH/OMB)(Participants) | Overall |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 61 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Overall |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 19 |
| White | 42 |
| More than one race | 5 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Overall |
|---|---|
| United States | 67 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Roswell Park Cancer Institute