Trial Outcomes & Findings for Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community (NCT NCT06289192)

NCT ID: NCT06289192

Last Updated: 2025-09-10

Results Overview

Acceptability and Feasibility will be assessed by the number of participants who complete intervention and surveys

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-09-10

Participant Flow

Participant milestones

Measure	Smoking Cessation Intervention Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community

Baseline characteristics by cohort

Measure	Smoking Cessation Intervention n=5 Participants Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.
Age, Customized <50 years	0 Participants n=5 Participants
Age, Customized >=50 years	5 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Current tobacco use	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Acceptability and Feasibility will be assessed by the number of participants who complete intervention and surveys

Outcome measures

Measure	Smoking Cessation Intervention n=5 Participants Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months. C-Raven Virtual Tobacco Cessation Counseling: 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. Nicotine Replacement Product: Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges. Community Health Worker: 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. Lung Cancer Screening: Eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.
Acceptability and Feasibility as Assessed by the Number of Participants Who Complete Intervention and Surveys Intervention completed	5 Participants
Acceptability and Feasibility as Assessed by the Number of Participants Who Complete Intervention and Surveys All surveys completed	5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Acceptability and Feasibility will be assessed by barriers to screening

Outcome measures

Measure	Smoking Cessation Intervention n=5 Participants Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months. C-Raven Virtual Tobacco Cessation Counseling: 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. Nicotine Replacement Product: Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges. Community Health Worker: 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. Lung Cancer Screening: Eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.
Acceptability and Feasibility as Assessed by Barriers to Screening Barriers to LDCT Screening, Baseline	25.2 barriers Standard Deviation 8.6
Acceptability and Feasibility as Assessed by Barriers to Screening Barriers to LDCT Screening, 1 Month	28.6 barriers Standard Deviation 14.4
Acceptability and Feasibility as Assessed by Barriers to Screening Barriers to LDCT Screening, 3 Months	31.8 barriers Standard Deviation 14.7

SECONDARY outcome

Timeframe: 3 months

Number of participants that start using NRTs during the study period

Outcome measures

Measure

Smoking Cessation Intervention n=5 Participants Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months. C-Raven Virtual Tobacco Cessation Counseling: 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. Nicotine Replacement Product: Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges. Community Health Worker: 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. Lung Cancer Screening: Eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.

Number of Participants That Uptake Nicotine Replacement Therapy

4 Participants

SECONDARY outcome

Timeframe: 3 months

Total number of interactions with CHW across all participants

Outcome measures

Measure

Smoking Cessation Intervention n=5 Participants Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months. C-Raven Virtual Tobacco Cessation Counseling: 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. Nicotine Replacement Product: Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges. Community Health Worker: 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. Lung Cancer Screening: Eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.

Participant Engagement With Community Health Worker (CHW) as Assessed by Number of CHW Interactions

60 CHW interactions

Adverse Events

Smoking Cessation Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alejandra Ellison-Barnes

Johns Hopkins University

Phone: n/a

Email: aelliso6@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place