Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06289192 |
| Other study ID # |
IRB00396489 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 30, 2024 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
