NCT04899492

Brief Summary

This trial offers support and assistance to patients wishing to quit smoking in order to increase the success rate of smoking cessation and all the benefits associated with it. Patients will be monitored by a tobacco specialist and will be able to benefit from one or more therapies complementary to Nicotine Replacement Therapy (NRT): Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy.

Trial Health

57
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Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

2.5 years

First QC Date

May 19, 2021

Last Update Submit

November 5, 2024

Conditions

Breast CancerGynecologic CancerDigestive CancerMelanoma

Keywords

Smoking CessationMotivational Interviewing (MI)Cognitive Behavioural Therapy (CBT)HypnotherapyNicotine Replacement Therapy (NRT)SurgerySurgery complicationslongitudinal cohort

Outcome Measures

Primary Outcomes (1)

  • Testing the feasibility of smoking cessation interventions evaluated in French cancer patients undergoing surgery

    Number of patients who completed all planned sessions out of the total number of patients randomised to each group

    12 months

Secondary Outcomes (8)

  • Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy

    12 months

  • Evaluate the efficacy of the following interventions for smoking cessation in French cancer patients: MI, CBT and Hypnotherapy, combined with nicotine replacement therapy

    12 months

  • Evaluate the efficacy of the different interventions in reducing tobacco consumption

    12 months

  • Evaluate the efficacy of the different interventions in terms of continued abstinence since surgery

    12 months

  • Evaluate the reduction in side effects of oncological treatments after smoking cessation

    3 month

  • +3 more secondary outcomes

Study Arms (4)

Group 1:Nicotine Replacement Therapy (NRT)

ACTIVE COMPARATOR

Patients enrolled in group 1 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study

Drug: Nicotine Replacement Therapy (NRT)

Group 2:Motivational Interviewing (MI)

EXPERIMENTAL

Patients enrolled in group 2 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization

Behavioral: Motivational Interviewing (MI)Drug: Nicotine Replacement Therapy (NRT)

Group 3:Cognitive Behavioural Therapy (CBT)

EXPERIMENTAL

Patients enrolled in group 3 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and 6 sessions of CBT after Motivational Interviewing up to 6 months after

Behavioral: Motivational Interviewing (MI)Behavioral: Cognitive Behavioural Therapy (CBT)Drug: Nicotine Replacement Therapy (NRT)

Group 4: Hypnotherapy

EXPERIMENTAL

Patients enrolled in group 4 will receive a Nicotine Replacement Therapy (NRT) from the study entry to end of study and 1 to 3 Motivational Interviewing (MI) after randomization and about 3 sessions of hypnotherapy up to 6 months after

Behavioral: Motivational Interviewing (MI)Behavioral: HypnotherapyDrug: Nicotine Replacement Therapy (NRT)

Interventions

Motivational Interviewing (MI)BEHAVIORAL

1 to 3 Motivational Interviewing (MI) should be performed after randomization by a psychotherapist

Group 2:Motivational Interviewing (MI)Group 3:Cognitive Behavioural Therapy (CBT)Group 4: Hypnotherapy
Cognitive Behavioural Therapy (CBT)BEHAVIORAL

6 Cognitive Behavioural Therapy (CBT) sessions should be performed after motivational interviewing up to 6 months by a psychotherapist

Group 3:Cognitive Behavioural Therapy (CBT)
HypnotherapyBEHAVIORAL

About 3 Hypnotherapy sessions should be performed after motivational interviewing up to 6 months by a hypnotherapist

Group 4: Hypnotherapy
Nicotine Replacement Therapy (NRT)DRUG

All patients will receive Nicotine Replacement Therapy (NRT) from randomization up to 6 months

Group 1:Nicotine Replacement Therapy (NRT)Group 2:Motivational Interviewing (MI)Group 3:Cognitive Behavioural Therapy (CBT)Group 4: Hypnotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Smoking patient: daily tobacco consumption.
  • Patient with cancer requiring surgical treatment (breast cancer, digestive cancer, gynecological).
  • Patient wishing to quit smoking.
  • Fagerström \> 3.
  • Patient has valid health insurance
  • Information and agreement of the patient to participate in the longitudinal cohort.
  • Signing of specific informed consent for patients in groups 1 to 4 before any study-related intervention.
  • Person able to speak, read and understand French.

You may not qualify if:

  • Patient not receiving surgical treatment.
  • Refusal to participate in the longitudinal cohort study.
  • Pregnant or likely to be pregnant or nursing patient.
  • Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian
  • disability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancerologie de l'Ouest (ICO)

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast NeoplasmsGastrointestinal NeoplasmsMelanomaSmoking Cessation

Interventions

Motivational InterviewingCognitive Behavioral TherapyHypnosisNicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesBehavior TherapyPsychotherapyMind-Body TherapiesComplementary TherapiesTherapeuticsDrug Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: pilot study, monocentric, prospective, randomization according to Zelen's design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

September 29, 2021

Primary Completion

March 29, 2024

Study Completion

March 29, 2024

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations

FR(1)