NCT06910566

Brief Summary

The TABAC STOP ORL POUMON study aims to evaluate the factors influencing long-term smoking cessation in patients with head and neck cancer (HNC) or lung cancer undergoing radiotherapy or chemoradiotherapy. This is a single-center observational study, following patients at 1, 6, and 12 months after treatment completion. The primary objective is to determine the proportion of abstinent patients at 6 months, while secondary objectives analyze factors influencing abstinence, smoking trajectories, and reasons for relapse. A total of 100 patients will be included to ensure robust statistical analysis.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Mar 2022Nov 2026

Study Start

First participant enrolled

March 28, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

March 19, 2025

Last Update Submit

March 16, 2026

Conditions

Nicotine AddictionSmokingHead and Neck NeoplasmsSmoking CessationNicotine Dependence

Keywords

Tobacco abstinenceHead and neck cancerSmoking cessationNicotine dependenceCancer treatment

Outcome Measures

Primary Outcomes (1)

  • Abstinence at 1 month and 6 months after the end of treatment

    The primary outcome measure will be abstinence at 1 month (physical consultation or telephone follow-up) and at 6 months after the end of treatment.

    1 and 6 months after the end of treatment.

Secondary Outcomes (6)

  • Proportion of patients willing to attend a smoking cessation consultation

    At the 1-month telephone follow-up after the end of treatment.

  • Abstinence at 1 month after the end of treatment

    1 month after the end of treatment

  • Abstinence at 6 months after the end of treatment

    6 months after the end of treatment

  • Abstinence at 12 months after the end of treatment

    12 months after the end of treatment

  • Cigarette dependence (Cigarette Dependence Scale, CDS)

    Baseline

  • +1 more secondary outcomes

Interventions

Chemoradiotherapy or radiotherapy alonePROCEDURE

Patients included in the study receive standard treatment with chemoradiotherapy or radiotherapy alone for their head and neck cancer or lung cancer. These treatments are part of their routine care and are not part of the observational study.

Also known as: chemoradiotherapy, radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients diagnosed with head and neck cancer (HNC) or lung cancer, who are undergoing curative treatment with chemoradiotherapy, radiotherapy alone, or stereotactic radiotherapy at the Centre Oscar Lambret in Lille, France. Participants are current or former smokers and are recruited during the last week of their radiotherapy treatment. The study aims to evaluate factors associated with maintaining tobacco abstinence in this specific patient population, focusing on their smoking cessation journey following cancer treatment

You may qualify if:

  • Patient aged 18 years or older
  • Diagnosed with head and neck cancer or lung cancer
  • Undergoing curative treatment with chemoradiotherapy, radiotherapy alone, or stereotactic radiotherapy
  • Current or former smoker
  • Patient covered by a social security scheme
  • Patient informed and having given consent for data collection
  • Patients with human papillomavirus (HPV) may also be included

You may not qualify if:

  • Patient receiving palliative treatment
  • Patient under guardianship or curatorship
  • Study Exit Criteria :
  • \- Protocol-defined exit : After the 12-month consultation
  • Early exit :
  • Withdrawal of consent for data collection
  • Death of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Smoking CessationTobacco Use DisorderSmokingHead and Neck Neoplasms

Interventions

ChemoradiotherapyRadiotherapy

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Gautier LEFEBVRE, MD

    Centre Oscar Lambret

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2025

First Posted

April 4, 2025

Study Start

March 28, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)