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NCT04675515 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04675515
Other study ID # D21008
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2021
Est. completion date January 1, 2025

Study information
Verified date September 2023
Source Dartmouth-Hitchcock Medical Center
Contact Joseph D Phillips, MD
Phone 603-650-8537
Email Joseph.D.PHillips@hitchcock.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Intensive Tobacco Treatment
Bi-weekly tobacco treatment counseling and regular carbon monoxide monitoring

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Duan W, Li S, Meng X, Sun Y, Jia C. Smoking and survival of breast cancer patients: A meta-analysis of cohort studies. Breast. 2017 Jun;33:117-124. doi: 10.1016/j.breast.2017.03.012. Epub 2017 Mar 31. — View Citation

Fay KA, Phillips JD, Hasson RM, Fannin A, Millington TM, Finley DJ. Outcomes of an Intensive, Preoperative Smoking Cessation Program. Ann Thorac Surg. 2020 Feb;109(2):e137-e139. doi: 10.1016/j.athoracsur.2019.08.075. Epub 2019 Oct 3. — View Citation

Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x. — View Citation

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. — View Citation

Phillips JD, Fay KA, Ramkumar N, Hasson RM, Fannin AV, Millington TM, Finley DJ. Long-Term Outcomes of a Preoperative Lung Resection Smoking Cessation Program. J Surg Res. 2020 Oct;254:110-117. doi: 10.1016/j.jss.2020.04.005. Epub 2020 May 16. — View Citation

Sharp L, McDevitt J, Brown C, Carsin AE, Comber H. Association between smoking at diagnosis and cause-specific survival in patients with rectal cancer: Results from a population-based analysis of 10,794 cases. Cancer. 2017 Jul 1;123(13):2543-2550. doi: 10 — View Citation

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. doi: 10.1378/chest.125.1.27. — View Citation

Yuan C, Morales-Oyarvide V, Babic A, Clish CB, Kraft P, Bao Y, Qian ZR, Rubinson DA, Ng K, Giovannucci EL, Ogino S, Stampfer MJ, Gaziano JM, Sesso HD, Cochrane BB, Manson JE, Fuchs CS, Wolpin BM. Cigarette Smoking and Pancreatic Cancer Survival. J Clin On — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Engagement Level With Tobacco Treatment for Low Resource Patients outh! 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 6 Months
Primary Change is smoking status 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 30 days, 3 Months, 6 Months
Secondary Motivational Impact of real-time carbon monoxide monitoring Motivational impact of real-time carbon monoxide monitoring in patients receiving intensive tobacco treatment as determined by a Motivation to Quit Assessment Questionnaire 6 Months
Secondary Engagement Level with Tobacco Treatment via Telehealth 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 6 Months
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