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Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment (PROACT)

Primary Purpose

Smoking Reduction, Tobacco Use, Tobacco Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unsigned note to provider about cessation medication prescription
Proactive Telephone Counseling from VA Quitline
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Reduction focused on measuring smoking cessation, lung cancer screening, telephone counseling, quitline

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
  • Providence VA Medical Center, Providence, RI
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Unstructured care

Proactive care

Arm Description

Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Providers' acceptance of proactive cessation care
Provider surveys will assess acceptance of and satisfaction with the proactive care approach among primary care clinicians referring Veterans for lung cancer screening
Cost of proactive cessation care
Costs of implementing the proactive care approach will be monitored and analyzed, including intervention staff effort, provider time, costs of telephone counseling, and pharmacotherapy costs
Patients' experience with telephone counseling
Patient surveys will assess satisfaction with VA Quitline telephone counseling
Patients' motivational assessment
Surveys will assess patient motivation to quit smoking
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' self-efficacy assessment
Surveys will assess patients' self-efficacy for quitting smoking
Patients' motivational assessment
Surveys will assess patient motivation to quit smoking
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' self-efficacy assessment
Surveys will assess patients' self-efficacy for quitting smoking

Full Information

First Posted
July 23, 2018
Last Updated
August 23, 2023
Sponsor
VA Office of Research and Development
Collaborators
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03612804
Brief Title
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment
Acronym
PROACT
Official Title
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Reduction, Tobacco Use, Tobacco Smoking, Tomography, Lung Diseases, Lung Neoplasms
Keywords
smoking cessation, lung cancer screening, telephone counseling, quitline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
828 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unstructured care
Arm Type
No Intervention
Arm Description
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
Arm Title
Proactive care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Unsigned note to provider about cessation medication prescription
Intervention Description
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 and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.
Intervention Type
Behavioral
Intervention Name(s)
Proactive Telephone Counseling from VA Quitline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported smoking abstinence
Description
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
Time Frame
12 months after lung cancer screening visit
Secondary Outcome Measure Information:
Title
Providers' acceptance of proactive cessation care
Description
Provider surveys will assess acceptance of and satisfaction with the proactive care approach among primary care clinicians referring Veterans for lung cancer screening
Time Frame
0-12 weeks after provider offers patient lung cancer screening
Title
Cost of proactive cessation care
Description
Costs of implementing the proactive care approach will be monitored and analyzed, including intervention staff effort, provider time, costs of telephone counseling, and pharmacotherapy costs
Time Frame
Through study completion
Title
Patients' experience with telephone counseling
Description
Patient surveys will assess satisfaction with VA Quitline telephone counseling
Time Frame
3 months after lung cancer screening visit
Title
Patients' motivational assessment
Description
Surveys will assess patient motivation to quit smoking
Time Frame
3 months after lung cancer screening visit
Title
Patients' perception of susceptibility to harm
Description
Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective
Time Frame
3 months after lung cancer screening visit
Title
Patients' self-efficacy assessment
Description
Surveys will assess patients' self-efficacy for quitting smoking
Time Frame
3 months after lung cancer screening visit
Title
Patients' motivational assessment
Description
Surveys will assess patient motivation to quit smoking
Time Frame
12 months after lung cancer screening visit
Title
Patients' perception of susceptibility to harm
Description
Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective
Time Frame
12 months after lung cancer screening visit
Title
Patients' self-efficacy assessment
Description
Surveys will assess patients' self-efficacy for quitting smoking
Time Frame
12 months after lung cancer screening visit

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven B. Zeliadt, PhD MPH
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010-5011
Country
United States
Facility Name
Providence VA Medical Center, Providence, RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4734
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1532
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
De-identified final datasets will be made available through publisher portals or other repositories identified by SCALE collaboration for ensuring dissemination and publication of trial findings upon completion of the study (2022). Preliminary (de-identified) datasets, study protocol, and statistical analysis plans may be made available to other researchers in the SCALE collaboration throughout the duration of the project.
IPD Sharing Access Criteria
Access will only be provided as necessary to allow transparency and evaluation of the results originally obtained by the Principal Investigator who generated the data or to expand upon the work. This assumes the recipient has knowledge, training and resources to adequately design and conduct the studies replicating the original work, or can otherwise determine the validity of results by reviewing the data provided.

Learn more about this trial

Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

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