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

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04675515
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.4
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use; Cancer	Behavioral: Intensive Tobacco Treatment	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CORE: CO Monitoring for Reach and Efficacy in Tobacco Treatment for Cancer Patients
• Actual Study Start Date: Jan 19, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Tobacco Treatment All individuals who are identified as tobacco users are offered tobacco treatment which includes proactive, as needed, contacts via in person, telehealth or telephone visits. for tobacco treatment, pharmacotherapy as indicated, and Quitline and SmokefreeTXT referrals
Experimental: 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.	Behavioral: Intensive Tobacco Treatment; Bi-weekly tobacco treatment counseling and regular carbon monoxide monitoring

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

Other Outcome Measures

1. Engagement Level With Tobacco Treatment for Low Resource Patients outh! [6 Months]

   Level of engagement with tobacco treatment for low-resource patients who are provided cell phones with data plans as determined by a Technology Access and Experiences Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center

Investigators

• Principal Investigator: Joseph D Phillips, MD, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Covita. Smokerlyzer. 2020

Publications

• Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27.
• Land SR, Warren GW, Crafts JL, Hatsukami DK, Ostroff JS, Willis GB, Chollette VY, Mitchell SA, Folz JN, Gulley JL, Szabo E, Brandon TH, Duffy SA, Toll BA. Cognitive testing of tobacco use items for administration to patients with cancer and cancer survivors in clinical research. Cancer. 2016 Jun 1;122(11):1728-34. doi: 10.1002/cncr.29964. Epub 2016 Mar 28.
• Tammemagi CM, Neslund-Dudas C, Simoff M, Kvale P. Smoking and lung cancer survival: the role of comorbidity and treatment. Chest. 2004 Jan;125(1):27-37.

• Responsible Party: Joseph D. Phillips, MD., Staff Physician, Thoracic Surgery, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT04675515
• Other Study ID Numbers: D21008
• First Posted: Dec 19, 2020
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 15, 2022