SmokerNCT03863795

Online Survey in Studying Smoking Attitudes and Behaviors Among Current Smokers

An observational study of Smoker, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This trial uses an online survey to study smoking attitudes and behaviors among current smokers. An online survey consisting of questions about general demographics, smoking history, smoking attitudes, smoking behaviors, smoking intentions, health and qualities of daily life may help researchers understand the… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Smoker
What is being tested?: Survey Administration
How many people: 1,100 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2019to 23 Mar 2019
Phase: Observational
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Smokers recruited through Amazon Mechanical Turk

Who may be able to join

United States (US) adult smokers.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

NCI Division of Cancer Control and Population Sciences
Rockville, Maryland, 20850

Other trials in United States

About this study

Official title: Self-Affirmation in the Context of Stigma-Induced Identity Threat Among Smokers

Read the detailed description

PRIMARY OBJECTIVES:

To examine if self-affirmation attenuates the effects of cigarette smoking stigmatization on smoking risk perceptions, pro-smoking beliefs, and intentions to change smoking behavior.

OUTLINE:

Participants are recruited and pre-screened via an online crowdsourcing program called Amazon Mechanical Turk (MTurk). Participants then respond to a one-time research survey over 20 minutes on SurveyGizmo, an on-line survey software platform.

Conditions: Smoker
Being tested: Survey Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Survey AdministrationOther
Respond to SurveyGizmo survey online

Study groups in NCT03863795
Study group	Role	What they receive
Observational (survey)		Participants are recruited and pre-screened via an online crowdsourcing program MTurk, and then respond to a one-time research survey over 20 minutes on SurveyGizmo, an on-line survey software platform Receives: Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Quit Intentions
Single item assessed intentions to quit smoking, 'Are you considering quitting smoking during the next 6 months?' from the 2014-2015 Tobacco Use Supplement to the Current Population Survey (1=yes, plan to stop within the next 30 days; 2=yes, plan to stop within the next 6 months, but not within 30 days; 3=no, not thinking of quitting in the next 6 months; U.S. Census Bureau, 2016). Response options were reverse scored so that higher scores indicated greater intentions to quit.
Measured: At the time of survey response within approximately 20 minutes
Intentions to Switch Completely to E-cigarettes
"How likely are you to switch completely from using regular cigarettes to electronic cigarettes in the next 6 months?' 1 (not at all likely) to 5 (extremely likely)
Measured: At the time of survey response within approximately 20 minutes
Intentions to Seek Cessation Counseling
How likely is it that in the next 6 months you will seek counseling/support to help you quit smoking? Response options were 1 (not at all likely) to 5 (extremely likely).
Measured: At the time of survey response within approximately 20 minutes
Intentions to Reduce Smoking
How likely is it that in the next 6 months that you will reduce the number of cigarettes you smoke in a day? Response options were 1 (not at all likely) to 5 (extremely likely).
Measured: At the time of survey response within approximately 20 minutes
Self-exempting Beliefs
Deterministic beliefs regarding smoking behaviors were evaluated using the 18-item self-exempting beliefs scale (Oakes et al., 2004).Response options were 1 (strongly disagree) to 5 (strongly agree). Items were averaged to create a composite measure of self-exempting beliefs with excellent interitem reliability, α = .91.
Measured: At the time of survey response within approximately 20 minutes.
Positive Cognitions About Smoking
Five items assessed positive cognitions about smoking (Fotuhi et al., 2013). Response options were 1 (strongly disagree) to 5 (strongly agree). Items were averaged to create a composite measure of self-exempting beliefs with excellent interitem reliability, α = .91.
Measured: At the time of survey response within approximately 20 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 201923 Mar 2019

First posted5 Mar 2019
Study start4 Feb 2019
Primary completion23 Mar 2019
Study completion23 Mar 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokerStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03863795
Sponsor's protocol ID: NCI-2019-01325
Other IDs: NCI-2019-01325, 19-NCI-00810
Status last verified: Aug 2021
First submitted: 4 Mar 2019
Last updated: 8 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Sorgen LJ, Ferrer RA, Klein WMP, Kaufman AR. Smoking self-concept moderates the effects of self-affirmation on smoking-related beliefs and behavioral intentions. Psychol Health. 2022 Aug;37(8):964-984. doi: 10.1080/08870446.2021.1912346. Epub 2021 Apr 19.
PubMed 33870815

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoker trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Self-Affirmation in the Context of Stigma-Induced Identity Threat Among Smokers
ClinicalTrials.gov ID: NCT03863795
Acronym / sponsor ID: NCI-2019-01325
Conditions: Smoker
Study type: Observational
Recruitment status: Completed
Enrolment: 1,100 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 4 Feb 2019 (actual)
Primary completion: 23 Mar 2019 (actual)
Study completion: 23 Mar 2019 (actual)
First posted: 5 Mar 2019 (actual)
Results: Posted 8 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To examine if self-affirmation attenuates the effects of cigarette smoking stigmatization on smoking risk perceptions, pro-smoking beliefs, and intentions to change smoking behavior.

OUTLINE:

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational (survey)	–	Other: Survey AdministrationParticipants are recruited and pre-screened via an online crowdsourcing program MTurk, and then respond to a one-time research survey over 20 minutes on SurveyGizmo, an on-line survey software platform

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Smokers recruited through Amazon Mechanical Turk

Key inclusion criteria (1 listed)

United States (US) adult smokers.

Key exclusion criteria (0 listed)

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
Survey AdministrationRespond to SurveyGizmo survey online	Other	Observational (survey)

Primary outcome

Quit Intentions
Time frame: At the time of survey response within approximately 20 minutes
Single item assessed intentions to quit smoking, 'Are you considering quitting smoking during the next 6 months?' from the 2014-2015 Tobacco Use Supplement to the Current Population Survey (1=yes, plan to stop within the next 30 days; 2=yes, plan to stop within the next 6 months, but not within 30 days; 3=no, not thinking of quitting in the next 6 months; U.S. Census Bureau, 2016). Response options were reverse scored so that higher scores indicated greater intentions to quit.
Intentions to Switch Completely to E-cigarettes
Time frame: At the time of survey response within approximately 20 minutes
"How likely are you to switch completely from using regular cigarettes to electronic cigarettes in the next 6 months?' 1 (not at all likely) to 5 (extremely likely)
Intentions to Seek Cessation Counseling
Time frame: At the time of survey response within approximately 20 minutes
How likely is it that in the next 6 months you will seek counseling/support to help you quit smoking? Response options were 1 (not at all likely) to 5 (extremely likely).
Intentions to Reduce Smoking
Time frame: At the time of survey response within approximately 20 minutes
How likely is it that in the next 6 months that you will reduce the number of cigarettes you smoke in a day? Response options were 1 (not at all likely) to 5 (extremely likely).
Self-exempting Beliefs
Time frame: At the time of survey response within approximately 20 minutes.
Deterministic beliefs regarding smoking behaviors were evaluated using the 18-item self-exempting beliefs scale (Oakes et al., 2004).Response options were 1 (strongly disagree) to 5 (strongly agree). Items were averaged to create a composite measure of self-exempting beliefs with excellent interitem reliability, α = .91.
Positive Cognitions About Smoking
Time frame: At the time of survey response within approximately 20 minutes.
Five items assessed positive cognitions about smoking (Fotuhi et al., 2013). Response options were 1 (strongly disagree) to 5 (strongly agree). Items were averaged to create a composite measure of self-exempting beliefs with excellent interitem reliability, α = .91.

Results and safety

Results posted to the registry on 8 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Smoking Stigma, Self-Affirmation	306	306
Smoking Stigma, No-Affirmation Control	269	269
Non-Stigma Control, Self-Affirmation	244	244
Non-Stigma Control, No-Affirmation Control	281	281

Primary outcome: Quit Intentions

Time frame: At the time of survey response within approximately 20 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Smoking Stigma, Self-Affirmation n = 306	Smoking Stigma, No-Affirmation Control n = 269	Non-Stigma Control, Self-Affirmation n = 244	Non-Stigma Control, No-Affirmation Control n = 280
Value	1.90 (.74)	1.72 (.71)	1.89 (.71)	1.79 (.70)

Population analysed: Listwise deletion: 1 participant did not respond to the survey item on quit intentions. Required summary level data only. Interpretation of these unadjusted results is not recommended. Please refer to manuscript for adjusted linear regression results.

Primary outcome: Intentions to Switch Completely to E-cigarettes

Time frame: At the time of survey response within approximately 20 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Smoking Stigma, Self-Affirmation n = 300	Smoking Stigma, No-Affirmation Control n = 265	Non-Stigma Control, Self-Affirmation n = 240	Non-Stigma Control, No-Affirmation Control n = 275
Value	2.29 (1.37)	2.28 (1.44)	2.17 (1.36)	2.32 (1.40)

Population analysed: Listwise Deletion: 20 participants did not respond to the intentions to switch to e-cigarettes survey item. Required summary level data only. Interpretation of these unadjusted results is not recommended. Please refer to manuscript for adjusted linear regression results.

Primary outcome: Intentions to Seek Cessation Counseling

Time frame: At the time of survey response within approximately 20 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Smoking Stigma, Self-Affirmation n = 297	Smoking Stigma, No-Affirmation Control n = 263	Non-Stigma Control, Self-Affirmation n = 238	Non-Stigma Control, No-Affirmation Control n = 274
Value	1.65 (1.03)	1.60 (1.06)	1.95 (1.25)	1.80 (1.17)

Population analysed: Listwise deletion: 28 participants did not respond to the survey item on intentions to seek cessation counseling. Required summary level data only. Interpretation of these unadjusted results is not recommended. Please refer to manuscript for adjusted linear regression results.

Primary outcome: Intentions to Reduce Smoking

Time frame: At the time of survey response within approximately 20 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Smoking Stigma, Self-Affirmation n = 303	Smoking Stigma, No-Affirmation Control n = 262	Non-Stigma Control, Self-Affirmation n = 240	Non-Stigma Control, No-Affirmation Control n = 274
Value	3.41 (1.32)	3.10 (1.31)	3.40 (1.28)	3.19 (1.29)

Population analysed: Listwise deletion: 21 participants did not respond to the survey item on intentions to reduce smoking. Required summary level data only. Interpretation of these unadjusted results is not recommended. Please refer to manuscript for adjusted linear regression results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Smoking Stigma, Self-Affirmation	0 of 0	0 of 0
Smoking Stigma, No-Affirmation Control	0 of 0	0 of 0
Non-Stigma Control, Self-Affirmation	0 of 0	0 of 0
Non-Stigma Control, No-Affirmation Control	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Required summary level data is presented per requirements. Do not interpret these unadjusted results. Please refer to the published manuscript for adjusted linear regression results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33870815Sorgen LJ, Ferrer RA, Klein WMP, Kaufman AR. Smoking self-concept moderates the effects of self-affirmation on smoking-related beliefs and behavioral intentions. Psychol Health. 2022 Aug;37(8):964-984. doi: 10.1080/08870446.2021.1912346. Epub 2021 Apr 19.

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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.

Annette Kaufman principal investigator

NCI Division of Cancer Control and Population Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Smoker, run by National Cancer Institute (NCI) 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 0 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 8 Sep 2021. 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 8 Sep 2021). 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?

Quit Intentions (time frame: At the time of survey response within approximately 20 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03863795, which also lists 1 linked publication.

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 8 Sep 2021.