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

NCT04675515 | Completed DMC

• 1 other identifier: D21008
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Motivational Impact of real-time carbon monoxide monitoring

  6 Months

• Engagement Level with Tobacco Treatment via Telehealth

  6 Months

Other Outcomes (1)

• Engagement Level With Tobacco Treatment for Low Resource Patients outh!

  6 Months

Study Arms (2)

Usual Tobacco Treatment

NO INTERVENTION

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

Intensive Tobacco Treatment

EXPERIMENTAL

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

Interventions

Intensive Tobacco Treatment BEHAVIORAL

Bi-weekly tobacco treatment counseling and regular carbon monoxide monitoring

Intensive Tobacco Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Adults unable to consent
• Prisoners

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (8)

• 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 Oncol. 2017 Jun 1;35(16):1822-1828. doi: 10.1200/JCO.2016.71.2026. Epub 2017 Mar 30.

  PMID: 28358654 BACKGROUND

• 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.

  PMID: 28371644 BACKGROUND

• 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: 10.1002/cncr.30583. Epub 2017 Mar 15.

  PMID: 28297071 BACKGROUND

• 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.

  PMID: 14718417 BACKGROUND

• 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.

  PMID: 31586615 BACKGROUND

• 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.

  PMID: 32428728 BACKGROUND

• 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.

  PMID: 1932883 BACKGROUND

• 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.

  PMID: 27019325 BACKGROUND

Related Links

• Covita. Smokerlyzer. 2020

MeSH Terms

Conditions

Tobacco Use; Neoplasms

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Joseph D Phillips, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Thoracic Surgery

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 19, 2020
• Study Start: January 19, 2021
• Primary Completion: November 7, 2023
• Study Completion: February 16, 2024
• Last Updated: July 14, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)