Trial Title:
Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community
NCT ID:
NCT06289192
Condition:
Tobacco Dependence
Conditions: Official terms:
Tobacco Use Disorder
Nicotine
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
C-Raven Virtual Tobacco Cessation Counseling
Description:
A two-module tobacco cessation intervention that involves interaction with a virtual
counselor and includes instruction about addiction and the use of pharmacotherapy for
cessation. Each module takes approximately 20 minutes to complete.
Arm group label:
Smoking Cessation Intervention
Intervention type:
Drug
Intervention name:
Nicotine Replacement Product
Description:
Participants will be offered a 12-week supply of nicotine patches and either nicotine gum
or lozenges.
Arm group label:
Smoking Cessation Intervention
Intervention type:
Other
Intervention name:
Community Health Worker
Description:
A community health worker will meet with each participant throughout the study period to
teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation,
conduct shared decision-making about lung cancer screening, and provide health system
navigation when needed.
Arm group label:
Smoking Cessation Intervention
Intervention type:
Other
Intervention name:
Lung Cancer Screening
Description:
Eligible participants will be referred to their primary care physician or existing
specialist to complete lung cancer screening.
Arm group label:
Smoking Cessation Intervention
Summary:
To inform a future randomized trial of a virtual counselor led computer delivered
intervention for tobacco cessation augmented with community health worker (CHW) support
and navigation to lung cancer screening in low-income housing units in Baltimore, the
investigators propose to collect data on intervention acceptability and feasibility among
individuals in public housing as well as feedback on use of shared decision making when
referring for low-dose chest CT (LDCT).
The investigators will conduct a feasibility pilot study of a virtual counselor plus
community health worker intervention. With a sample of participants from public housing
units (N=15), the investigators will collect data on feasibility of recruitment,
intervention engagement and completion, and short-term smoking cessation outcomes.
Individuals will be assessed at baseline, 1 month and 3 months. At the end of three
months, the investigators will conduct follow up interviews with a subset of pilot
participants to collect qualitative data on intervention acceptability. Based on this
information, the investigators will make iterative improvements to the combined
intervention.
Detailed description:
In anticipation of a future two-arm type 1 hybrid effectiveness-implementation randomized
controlled trial comparing a virtual counselor-led computer delivered intervention (VCTC)
augmented with CHW support in low-income housing units in Baltimore City. This pilot
study will generate preliminary data for a larger study. The investigators will conduct a
feasibility pilot study of the entire VCTC and CHW intervention with a sample of
participants (N=15) to collect data on the feasibility of recruitment, intervention
engagement and completion, and short-term smoking cessation outcomes. Individuals will be
assessed at baseline, one month, and three months. At the end of three months, the
investigators will conduct follow-up interviews with a subset of pilot participants to
collect qualitative data on intervention acceptability. Based on the information
collected in these efforts, the investigators will make iterative improvements to the
existing intervention, aligned with user-experience design procedures.
Participants will be recruited through flyers posted in and around the housing units and
distributed to tenants by housing unit staff. Flyers will describe the study and contain
a study phone number to call. Information may also be distributed by study staff during
non-study-related health and wellness activities conducted at the sites. At initial
contact, a study staff member will discuss the study purpose and determine eligibility.
If eligible, the staff member will proceed to discuss requirements, review risks and
benefits, and obtain informed consent from interested participants.
Consent process: After confirming eligibility with screening questions via phone,
potential participants will be offered the option of reviewing the study information and
consent form over a Zoom video conference. Regardless of whether the participants choose
to review this information in advance, all potential participants will complete the
consent process and sign the consent form at the beginning of the first in-person visit,
which will be conducted on-site at the participants housing community.
Baseline Assessment: This will occur on the same day as the in-person portion of the
consent process. Initial evaluation will comprise the research assessments detailed in
Table 1, including demographics, a clinical history, a tobacco use history, and a number
of tobacco-related measures. Assessments will be self-administered via tablet computer.
Intervention:
Computer-Delivered Intervention (CDI) Session 1: Following the baseline assessment,
participants will receive computer-delivered counseling via a study-provided iPad
delivered in a private room. VCTC consists of 1) a menu-driven, web-based intervention
that is delivered by a virtual counselor. The intervention takes 20 minutes to complete.
At the conclusion of session 1, the participant will be offered nicotine patches provided
by the study (1 month supply, remainder given at follow-up visits). The initial dosing of
the nicotine patches will be determined based on cigarettes consumed per day (>10: 21mg
patch, 5-10: 14mg patch, <5: 7mg patch). If there is any question regarding eligibility
or appropriate dosing, the CHW will consult with a study physician. With the CHW, the
participant will learn correct application, and will monitor the participants nicotine
replacement therapy (NRT) experience in discussion with the CHW.
Computer-Delivered Intervention (CDI) Session 2: Session 2, delivered approximately one
week later, focuses on the cycle of addiction and use of pharmacotherapy (e.g., NRT,
bupropion, varenicline). This intervention also takes about 20 minutes to complete. At
the conclusion of session 2, the participant will be offered nicotine gum or lozenges
provided by the study (1 month supply, remainder given at follow-up visits). This session
also includes an in-session experience of using NRT gum or lozenge, with CHW guidance to
ensure correct use.
Community Health Workers (CHWs): A CHW will meet with each participant for both Sessions
1 and 2 and will do the following: 1) Teach appropriate NRT use technique as above, 2)
Follow up with patients remotely via phone or video conference whenever possible, up to
twice weekly for 12 weeks, to discuss barriers/facilitators to maintenance of NRT use and
tobacco cessation; 3) Review the modified lung cancer shared decision-making guide from
Phase 1 and provide linkage to lung cancer screening if the participant is eligible and
interested, including linkage to insurance enrollment assistance, if needed; 4) For
individuals requiring follow up for positive findings on lung CT, work with participants
to navigate the process; 5) Link interested participants to the QuitLine; 6) At the end
of the study, link to medical providers for additional tobacco cessation therapy if
participant interested (e.g., varenicline, bupropion).
Linkage to Lung Cancer Screening: Participants eligible for and interested in CT Lung
cancer screening (age ≥50, ≥20 pack year smoking history) will be referred to the
participants primary care physician (PCP) or existing specialist for further discussion
and ordering. The CTs are optional and will not be provided as part of the research
study. The CHW will assist with linking patients without a PCP or existing specialist
with resources to establish care. For participants who choose to proceed with screening,
the investigators will request the results of the CT scan to track completion and general
result category (Normal/Normal with Minor Findings/Abnormal Needing Short-Term
Follow-Up/Abnormal Needing Immediate Follow-Up).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 50 or older
- Current tobacco use with >100 cigarettes smoked in their lifetime
- English speaking (intervention currently in English only and housing units are in
largely English-speaking neighborhoods)
- Considering smoking cessation
- Planning to remain in current housing unit for 6 months
Exclusion Criteria:
- Current use of pharmacological treatment for tobacco cessation
- Contraindication to nicotine replacement therapy
- Current engagement in formal smoking cessation program
- Major cognitive or psychiatric impairment
- Severe hearing impairment
- Investigator discretion
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chase House Apartments
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Facility:
Name:
Monument East
Address:
City:
Baltimore
Zip:
21202
Country:
United States
Facility:
Name:
Johns Hopkins University School of Medicine
Address:
City:
Baltimore
Zip:
21205
Country:
United States
Start date:
April 30, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Collaborator:
Agency:
Maryland Cigarette Restitution Fund
Agency class:
Other
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06289192