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Tobacco UseNCT04675515

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

A study testing Intensive Tobacco Treatment in people with Tobacco Use and Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tobacco Use, Cancer
What is being tested?
Intensive Tobacco Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
19 Jan 2021to 16 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Adults unable to consent
  • Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

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.

Read the 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.

Conditions
Tobacco Use, Cancer
Being tested
Intensive Tobacco Treatment
Medical subject headings
Tobacco Use, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Tobacco TreatmentBehavioural

    Bi-weekly tobacco treatment counseling and regular carbon monoxide monitoring

Study groups in NCT04675515
Study groupRoleWhat they receive
Usual Tobacco TreatmentNo interventionAll 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 TreatmentExperimentalPatients 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.
Receives: Behavioral: Intensive Tobacco Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days, 3 Months, 6 Months

Secondary outcomes (2)

  1. 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

    Measured: 6 Months

  2. 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

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start19 Jan 2021
  3. Primary completion7 Nov 2023
  4. Study completion16 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04675515
Sponsor's protocol ID
D21008
Status last verified
Sep 2024
First submitted
11 Dec 2020
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14718417

  • 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.

    PubMed 1932883

  • 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.

    PubMed 27019325

  • 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.

    PubMed 28358654

  • 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.

    PubMed 28371644

  • 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.

    PubMed 28297071

  • 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.

    PubMed 31586615

  • 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.

    PubMed 32428728

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Tobacco Treatment in people with Tobacco Use and Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change is smoking status (time frame: 30 days, 3 Months, 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04675515, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.

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