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

NCT ID: NCT04675515

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-19

Study Completion Date

2024-02-16

Brief Summary

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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

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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.

Conditions

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Tobacco Use Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Intensive Tobacco Treatment

Intervention Type BEHAVIORAL

Bi-weekly tobacco treatment counseling and regular carbon monoxide monitoring

Interventions

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Intensive Tobacco Treatment

Bi-weekly tobacco treatment counseling and regular carbon monoxide monitoring

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Phillips, MD.

Staff Physician, Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph D Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28358654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28371644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28297071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14718417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31586615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32428728 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1932883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27019325 (View on PubMed)

Related Links

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Other Identifiers

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D21008

Identifier Type: -

Identifier Source: org_study_id

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