Smoking ReductionPROACTNCT03612804
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment
A study testing Unsigned note to provider about cessation medication prescription and Proactive Telephone Counseling from VA Quitline in people with Smoking Reduction and Tobacco Use, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Smoking Reduction, Tobacco Use, Tobacco Smoking
- What is being tested?
- Unsigned note to provider about cessation medication prescription and Proactive Telephone Counseling from VA Quitline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 944 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 May 2019to 9 Feb 2023
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Providers who schedule patients for a lung cancer screening at either of the two VA sites.
- Patients who participate in lung cancer screening and are current smokers at the time of scheduling their screening exam.
Who cannot join
- Providers who currently systematically prescribe cessation support medication to all current smokers will be excluded.
- Patients with urgent findings requiring biopsy/immediate attention on the screening CT will be excluded.
- Patients with a prior diagnosis of lung cancer or who are receiving active therapy for any cancer, except skin cancer, will be excluded.
- Patients previously diagnosed with cognitive impairment, dementia, or severe behavioral disorders, or have an indication in chart review of difficulty communicating or participating in telephone counseling sessions will be excluded.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.
Read the detailed description
This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.
- Conditions
- Smoking Reduction, Tobacco Use, Tobacco Smoking, Tomography, Lung Diseases, Lung Neoplasms
- Being tested
- Unsigned note to provider about cessation medication prescription, Proactive Telephone Counseling from VA Quitline
- Keywords
- smoking cessation, lung cancer screening, telephone counseling, quitline
- Medical subject headings
- Smoking Reduction, Tobacco Use, Tobacco Smoking, Lung Diseases, Lung Neoplasms, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsigned note to provider about cessation medication prescriptionBehavioural
For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA QuitlineBehavioural
Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
| Study group | Role | What they receive |
|---|---|---|
| Unstructured care | No intervention | Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team. |
| Proactive care | Experimental | Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling. Receives: Behavioral: Unsigned note to provider about cessation medication prescription; Behavioral: Proactive Telephone Counseling from VA Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Smoking Abstinence
The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records. This measure only applies to patient enrollees.
Measured: 12 months after lung cancer screening visit
Secondary outcomes (7)
Cost of Smoking Cessation Care
Costs of implementing smoking cessation care from lung cancer screening to 12 months post-lung cancer screening will be monitored in both the unstructured and proactive care arms. Cost of implementing smoking cessation care is defined as the sum of the cost of behavioral counseling, cost of pharmacotherapies, and cost of intervention staff effort. This measure only applies to patient enrollees.
Measured: Time period from lung cancer screening through 12 months after lung cancer screening
Patients' Experience With Telephone Counseling
Binary variable for whether participant reported being either very satisfied or somewhat satisfied with VA Quitline telephone counseling. This measure only applies to patient enrollees in the proactive arm.
Measured: 3 months after lung cancer screening visit
Patients' Motivational Assessment
Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.
Measured: 3 months after lung cancer screening visit
Patients' Perception of Susceptibility to Harm
Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective. Patients were asked 5 questions related to smoking and screening, and an overall score based on the sum of correct answers was calculated. Scores range from 0-5 (higher scores indicate greater knowledge about harmful effects of smoking and benefits of screening). This measure only applies to patient enrollees.
Measured: 3 months after lung cancer screening visit
Patients' Self-efficacy Assessment
Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees.
Measured: 3 months after lung cancer screening visit
Patients' Motivational Assessment
Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.
Measured: 12 months after lung cancer screening visit
Patients' Self-efficacy Assessment
Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees.
Measured: 12 months after lung cancer screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start10 May 2019
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
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 Smoking ReductionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 944 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Fred Hutchinson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Steven B Zeliadt, PhD MPH, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612804
- Sponsor's protocol ID
- IIR 16-071
- Acronym
- PROACT
- Status last verified
- Sep 2024
- First submitted
- 23 Jul 2018
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators anticipate publishing the findings alongside other similar trials funded by NCI through the Smoking Cessation within the Context of Lung Cancer Screening (SCALE) collaboration, with journals that will likely require concurrent publication of de-identified datasets.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment
- ClinicalTrials.gov ID
- NCT03612804
- Acronym / sponsor ID
- PROACT / IIR 16-071
- Conditions
- Smoking Reduction, Tobacco Use, Tobacco Smoking, Tomography, Lung Diseases, Lung Neoplasms
- Keywords
- smoking cessation, lung cancer screening, telephone counseling, quitline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 944 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Fred Hutchinson Cancer Center
- Study start
- 10 May 2019 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.
Detailed description
This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unstructured care | No intervention | –Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team. |
| Proactive care | Experimental | Behavioral: Unsigned note to provider about cessation medication prescription, Behavioral: Proactive Telephone Counseling from VA QuitlineProviders in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Providers who schedule patients for a lung cancer screening at either of the two VA sites.
- Patients who participate in lung cancer screening and are current smokers at the time of scheduling their screening exam.
Key exclusion criteria (4 listed)
- Providers who currently systematically prescribe cessation support medication to all current smokers will be excluded.
- Patients with urgent findings requiring biopsy/immediate attention on the screening CT will be excluded.
- Patients with a prior diagnosis of lung cancer or who are receiving active therapy for any cancer, except skin cancer, will be excluded.
- Patients previously diagnosed with cognitive impairment, dementia, or severe behavioral disorders, or have an indication in chart review of difficulty communicating or participating in telephone counseling sessions will be excluded.
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 |
|---|---|---|
| Unsigned note to provider about cessation medication prescriptionFor patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines. | Behavioural | Proactive care |
| Proactive Telephone Counseling from VA QuitlinePatients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support. | Behavioural | Proactive care |
Primary outcome
Self-reported Smoking Abstinence
Time frame: 12 months after lung cancer screening visit
The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records. This measure only applies to patient enrollees.
7 secondary outcomes
Cost of Smoking Cessation Care
Time frame: Time period from lung cancer screening through 12 months after lung cancer screening
Patients' Experience With Telephone Counseling
Time frame: 3 months after lung cancer screening visit
Patients' Motivational Assessment
Time frame: 3 months after lung cancer screening visit
Patients' Perception of Susceptibility to Harm
Time frame: 3 months after lung cancer screening visit
Patients' Self-efficacy Assessment
Time frame: 3 months after lung cancer screening visit
Patients' Motivational Assessment
Time frame: 12 months after lung cancer screening visit
Patients' Self-efficacy Assessment
Time frame: 12 months after lung cancer screening visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The investigators anticipate publishing the findings alongside other similar trials funded by NCI through the Smoking Cessation within the Context of Lung Cancer Screening (SCALE) collaboration, with journals that will likely require concurrent publication of de-identified datasets.
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Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
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Recruiting
A Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Cigarette Smokers Using an Electronic Nicotine Delivery System
Smoking, Tobacco
Enrolling by invitation
Clinical Alternatives for Reducing Harm Using E-cigarettes
Smoking, E-Cig Use
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.
Steven B Zeliadt, PhD MPH principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unsigned note to provider about cessation medication prescription and Proactive Telephone Counseling from VA Quitline in people with Smoking Reduction and Tobacco Use, run by VA Office of Research and Development at 3 sites 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 2 inclusion and 4 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Oct 2024). 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?
Self-reported Smoking Abstinence (time frame: 12 months after lung cancer screening visit). 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 8 Oct 2024.