Smoking TobaccoNCT03657511
Tobacco Cessation Intervention
A study testing Educational Interventions to Promote Tobacco Cessation in people with Smoking Tobacco, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
This study is planned as an evaluation of a low cost, simple smoking cessation intervention. There is very little information about the effectiveness of a simple tobacco cessation strategy. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Tobacco
- What is being tested?
- Educational Interventions to Promote Tobacco Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 21 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and read English
Who cannot join
- Currently undergoing tobacco cessation treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Educational Interventions to Promote Tobacco Cessation Among Women Seeking Mammography Screening
This study is planned as an evaluation of a low cost, simple smoking cessation intervention. There is very little information about the effectiveness of a simple tobacco cessation strategy. Therefore, our objective is to obtain estimates of effectiveness that can be used to refine existing programs or to develop new ones.
- Conditions
- Smoking Tobacco
- Being tested
- Educational Interventions to Promote Tobacco Cessation
- Keywords
- Smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Interventions to Promote Tobacco CessationBehavioural
Women receiving a screening mammogram at KCI downtown and McLaren Macomb, will be given a self-administered questionnaire at check-in.
Women who indicate they are current smokers are eligible for the study. After the screening mammogram is complete, eligible women will be consented. Educational materials will be provided to the participant at that time. The materials provided outline evidence-based approaches to smoking cessation and include contact information for local resources including cessation support groups, Michigan Tobacco Quitline, American Cancer Society's Guide to Quitting Smoking, Quitnet, Smokfree.gov and Become An Ex. The participant will be contacted by telephone approximately 12 weeks later to determine if she is currently smoking or had quit in the last 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Educational Interventions to Promote Tobacco Cessation | Other | Not described Receives: Behavioral: Educational Interventions to Promote Tobacco Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who quit smoking in the last 12 weeks
Completion of second questionnaire to determine if participant is currently smoking or had quit smoking in the last 12 weeks.
Measured: 12 weeks after initial self-administered questionnaire
Secondary outcomes (1)
The number of women who attempted to quit smoking in the last 12 weeks.
Completion of second questionnaire to determine if participant is currently smoking or had quit smoking in the last 12 weeks.
Measured: 12 weeks after initial self-administered questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start22 Oct 2018
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking TobaccoStudies of the same condition, open and under way.
- 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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Schwartz, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657511
- Sponsor's protocol ID
- 2018-006
- Status last verified
- May 2022
- First submitted
- 31 Aug 2018
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Interventions to Promote Tobacco Cessation Among Women Seeking Mammography Screening
- ClinicalTrials.gov ID
- NCT03657511
- Acronym / sponsor ID
- 2018-006
- Conditions
- Smoking Tobacco
- Keywords
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is planned as an evaluation of a low cost, simple smoking cessation intervention. There is very little information about the effectiveness of a simple tobacco cessation strategy. Therefore, our objective is to obtain estimates of effectiveness that can be used to refine existing programs or to develop new ones.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Interventions to Promote Tobacco Cessation | Other | Behavioral: Educational Interventions to Promote Tobacco Cessation |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to understand and read English
Key exclusion criteria (1 listed)
- Currently undergoing tobacco cessation treatment
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 |
|---|---|---|
| Educational Interventions to Promote Tobacco CessationWomen receiving a screening mammogram at KCI downtown and McLaren Macomb, will be given a self-administered questionnaire at check-in. Women who indicate they are current smokers are eligible for the study. After the screening mammogram is complete, eligible women will be consented. Educational materials will be provided to the participant at that time. The materials provided outline evidence-based approaches to smoking cessation and include contact information for local resources including cessation support groups, Michigan Tobacco Quitline, American Cancer Society's Guide to Quitting Smoking, Quitnet, Smokfree.gov and Become An Ex. The participant will be contacted by telephone approximately 12 weeks later to determine if she is currently smoking or had quit in the last 12 weeks. | Behavioural | Educational Interventions to Promote Tobacco Cessation |
Primary outcome
The number of women who quit smoking in the last 12 weeks
Time frame: 12 weeks after initial self-administered questionnaire
Completion of second questionnaire to determine if participant is currently smoking or had quit smoking in the last 12 weeks.
1 secondary outcome
The number of women who attempted to quit smoking in the last 12 weeks.
Time frame: 12 weeks after initial self-administered questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Interventions to Promote Tobacco Cessation in people with Smoking Tobacco, run by Barbara Ann Karmanos 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 6 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of women who quit smoking in the last 12 weeks (time frame: 12 weeks after initial self-administered questionnaire). 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 6 May 2022.