Bladder CancerNCT00957424
Acceptability of Less Harmful Alternatives to Cigarettes
A study testing telephone-based intervention, nicotine replacement therapy and informational intervention in people with Bladder Cancer and Cervical Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bladder Cancer, Cervical Cancer, Esophageal Cancer
- What is being tested?
- telephone-based intervention, nicotine replacement therapy and informational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study
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.
Read the 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.
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
- Being tested
- telephone-based intervention, nicotine replacement therapy, informational intervention, internet-based intervention, questionnaire administration
- 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
- Medical subject headings
- Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Leukemia, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-based interventionBehavioural
10-15 minute web-based survey on a computer
nicotine replacement therapyDrug
One week supply
informational interventionOther
internet-based interventionOther
questionnaire administrationOther
Given out week 2, 3 and 4.
| Study group | Role | What they receive |
|---|---|---|
| Overall | Other | Single-armed study Receives: Behavioral: telephone-based intervention; Drug: nicotine replacement therapy; Other: informational intervention; Other: internet-based intervention; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)
Measured: Baseline
Number of Participants Willing to Try HRPs
Measured: Baseline
Number of Participants That Completed 1-week Trial
Measured: One week
Number of Participants Willing to Continue With Preferred HRP
Measured: 1 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Martin Mahoney, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957424
- Sponsor's protocol ID
- CDR0000648665
- Other IDs
- P30CA016056, RPCI-I-118207
- Status last verified
- Dec 2016
- First submitted
- 11 Aug 2009
- Last updated
- 7 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study
- ClinicalTrials.gov ID
- NCT00957424
- Acronym / sponsor ID
- CDR0000648665
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
- Keywords
- tobacco use disorder, bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Posted 14 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall | Other | Behavioral: telephone-based intervention, Drug: nicotine replacement therapy, Other: informational intervention, Other: internet-based intervention, Other: questionnaire administrationSingle-armed study |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone-based intervention10-15 minute web-based survey on a computer | Behavioural | Overall |
| nicotine replacement therapyOne week supply | Drug | Overall |
| informational intervention | Other | Overall |
| internet-based intervention | Other | Overall |
| questionnaire administrationGiven out week 2, 3 and 4. | Other | Overall |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Mahoney, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone-based intervention, nicotine replacement therapy and informational intervention in people with Bladder Cancer and Cervical Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.