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Terminated

NCT Number: NCT04899492

Evaluating Smoking Cessation Protocols in Cancer Patients: NRT, MI, CBT or Hypnotherapy

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.

Why the study stopped: lack of patient enrolment
Terminated

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Digestive Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gynecologic Cancer Health Behavior Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de l'Ouest (ICO)

Saint-Herblain, 44805, France

About this study

The study RESPIRE is aiming to identify some interventions to be proposed as part of a smoking cessation programme for smokers with cancer requiring surgical treatment and wishing to stop smoking. We aim to compare different smoking cessation methods in addition to the currently recommended treatments: Nicotine Replacement Therapy (NRT). These procedures are: Cognitive Behavioural Therapy (CBT), Motivational Interviewing (MI) or hypnotherapy in order to improve the success rate of smoking cessation in this specific population.

All patients wishing to be supported to stop smoking will be randomized and will be followed by a tobacco specialist before and after surgery. They will receive NRT for 12 months.

Smoking assessment, exhaled CO measurement, questionnaires will be completed regularly to assess depression, anxiety and quality of life during the 12 months.

Patients randomized in group 2 will receive 1 to 3 MI. Patients randomized in group 3 will receive 1 to 3 MI and 6 CBT sessions by a psychotherapist.

Patients randomized in group 4 will receive 1 to 3 MI and at least 3 sessions oh hypnotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Motivational Interviewing (MI)

Behavioral

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

Cognitive Behavioural Therapy (CBT)

Behavioral

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

Hypnotherapy

Behavioral

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

Nicotine replacement therapy (NRT)

Drug

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

Primary outcomes

  1. Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Collaborators

  • National Cancer Institute, France

Registry information

Official study title

Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement (NRT), Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy

Acronym: RESPIRE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 24, 2021
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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