CORE: CO Monitoring for Reach and Efficacy in Tobacco Treatment for Cancer Patients

Not Applicable

Recruiting

• Conditions: Tobacco Use; Cancer
• Interventions: Behavioral: Intensive Tobacco Treatment

• Registration Number: NCT04675515
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

The purpose of this study is to assess the cessation success rates of an intensive tobacco treatment program in a patients undergoing cancer treatment at 30 days, 3 months and 6 months.

Detailed Description

This mixed-methods, observational cohort study will assess intensive tobacco treatment with carbon monoxide monitoring offered to all eligible smoking patients presenting for cancer treatment to the NCCC at our main Lebanon campus and our very rural St. Johnsbury campus. Subjects will not be randomized and study will not be blinded. Cessation rates among the intensive tobacco treatment will be compared to usual care, matched historical controls, and to patients who refuse all tobacco treatment program elements.

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Study Start: 2021-01-19
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults age 18 and older
• Active Smoker at the time of initial consultation for cancer (defined as any smoking within 2 weeks of consult)

Exclusion Criteria

• Adults unable to consent
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Tobacco Treatment	Intensive Tobacco Treatment	Patients who consent to study participation will meet with a tobacco treatment specialist in-person initially, then biweekly via telephone or telehealth or face-to-face (or more frequently as needed). They will receive tobacco treatment counseling and support from certified tobacco treatment specialist, which may include pharmacotherapy as indicated. At enrollment, participants will undergo carbon monoxide testing using a carbon monoxide monitor. At baseline, participants will complete the Fagerström Test for Nicotine Dependence, and the Cancer Patient Tobacco Use Questionnaire (C-TUQ). These tobacco related survey measures will be completed at 3 additional time points: 30 days, 3 months and 6 months.

Primary Outcome Measures

Name	Time	Method
Change is smoking status	30 days, 3 Months, 6 Months	Change in smoking status (from smoking to not smoking) of those in an intensive tobacco treatment program at 30 days, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
Motivational Impact of real-time carbon monoxide monitoring	6 Months	Motivational impact of real-time carbon monoxide monitoring in patients receiving intensive tobacco treatment as determined by a Motivation to Quit Assessment Questionnaire
Engagement Level with Tobacco Treatment via Telehealth	6 Months	Level of engagement with tobacco treatment via telehealth compared to historical control face-to-face visits as determined by a Technology Access and Experiences Questionnaire

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States