SmokingPhase 2/3NCT00169260
Proactive Health Intervention for Tobacco Users (Get PHIT)
A Phase 2/3 study testing motivational counseling in people with Smoking, run by Kaiser Permanente at 1 site in United States.
Trial summary
The goal of this study is to understand how information about smokers' health risks affects their attitudes, mood, and behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- motivational counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 536 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Feb 2010
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old,
- smoke greater than or equal to 15 cigarettes a day,
- have an expired CO level greater than or equal to 10 ppm,
- are not currently being treated for smoking cessation,
- can read and write in English,
- provide contact information,
Show all 9Show fewer
- agree to the study requirements,
- have no medical contraindications for spirometry assessment,
- and no an obvious cognitive or physical impairment that would preclude their ability to comprehend or fully participate in the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proactive Cessation Intervention With Biomarker Feedback
The goal of this study is to understand how information about smokers' health risks affects their attitudes, mood, and behavior.
Read the detailed description
The current study will test a community-based, tobacco intervention. The project will compare the effects of a proactive, personally-tailored, biologically-based motivational intervention to those of a proactive, generic motivational intervention for smoking cessation. The biologically-based motivational treatment will include feedback on participants' carbon monoxide (CO) exposure (expired CO and estimated carboxyhemoglobin levels), pulmonary functioning assessed via spirometry, and self-reported smoking-related symptoms. All participants will be given equal access to action-oriented treatment.
- Conditions
- Smoking
- Being tested
- motivational counseling, placebo
- Keywords
- smoking, tobacco, behavior therapy
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational counselingBehavioural
behavioral motivational counselling
placeboBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention Receives: Behavioral: motivational counseling |
| 2 | Placebo comparator | Control Receives: Behavioral: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation to quit smoking, utilization of available resources, smoking cessation rate
Measured: 1 year
Secondary outcomes (1)
Measurement of emotional distress, and mediators/moderators of primary outcomes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer B McClure, Ph.D., Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169260
- Sponsor's protocol ID
- 5R01CA100341-02
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2005
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of spirometry feedback and brief motivational counseling on long-term smoking outcomes: a comparison of smokers with and without lung impairment. Patient Educ Couns. 2010 Aug;80(2):280-3. doi: 10.1016/j.pec.2009.11.002.
PubMed 20434863McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of a brief motivational smoking cessation intervention the Get PHIT randomized controlled trial. Am J Prev Med. 2009 Aug;37(2):116-23. doi: 10.1016/j.amepre.2009.03.018. Epub 2009 Jun 12.
PubMed 19524389
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Cessation Intervention With Biomarker Feedback
- ClinicalTrials.gov ID
- NCT00169260
- Acronym / sponsor ID
- 5R01CA100341-02
- Conditions
- Smoking
- Keywords
- smoking, tobacco, behavior therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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.
The goal of this study is to understand how information about smokers' health risks affects their attitudes, mood, and behavior.
Detailed description
The current study will test a community-based, tobacco intervention. The project will compare the effects of a proactive, personally-tailored, biologically-based motivational intervention to those of a proactive, generic motivational intervention for smoking cessation. The biologically-based motivational treatment will include feedback on participants' carbon monoxide (CO) exposure (expired CO and estimated carboxyhemoglobin levels), pulmonary functioning assessed via spirometry, and self-reported smoking-related symptoms. All participants will be given equal access to action-oriented treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: motivational counselingIntervention |
| 2 | Placebo comparator | Behavioral: placeboControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years old,
- smoke greater than or equal to 15 cigarettes a day,
- have an expired CO level greater than or equal to 10 ppm,
- are not currently being treated for smoking cessation,
- can read and write in English,
Key exclusion criteria (1 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 |
|---|---|---|
| motivational counselingbehavioral motivational counselling | Behavioural | 1 |
| placebo | Behavioural | 2 |
Primary outcome
Motivation to quit smoking, utilization of available resources, smoking cessation rate
Time frame: 1 year
1 secondary outcome
Measurement of emotional distress, and mediators/moderators of primary outcomes
Time frame: 1 year
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 13 Aug 2018.
- Derived from this study: PubMed 20434863McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of spirometry feedback and brief motivational counseling on long-term smoking outcomes: a comparison of smokers with and without lung impairment. Patient Educ Couns. 2010 Aug;80(2):280-3. doi: 10.1016/j.pec.2009.11.002.
- Derived from this study: PubMed 19524389McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of a brief motivational smoking cessation intervention the Get PHIT randomized controlled trial. Am J Prev Med. 2009 Aug;37(2):116-23. doi: 10.1016/j.amepre.2009.03.018. Epub 2009 Jun 12.
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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.
Jennifer B McClure, Ph.D. principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing motivational counseling in people with Smoking, run by Kaiser Permanente 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 9 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 13 Aug 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Motivation to quit smoking, utilization of available resources, smoking cessation rate (time frame: 1 year). 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 NCT00169260, which also lists 2 linked publications.
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 13 Aug 2018.