Smoking Cessation in Cancer Treatment

August 20, 2019 updated by: Arnfinn Helleve, Norwegian Institute of Public Health

An Intervention Study of a Smoking Cessation Program Offered to Newly Diagnosed Cancer Patients at Their First Consultation for Treatment at an Oncological Hospital Department

The intervention to be studied is a smoking cessation program offered to newly diagnosed cancer patients at their first consultation for treatment at an oncological hospital department.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The theoretical basis for the smoking cessation program is motivational interviewing (MI), an established counselling method previously used in smoking cessation programs as well as in other behaviour change programs. MI is defined as "a directive, client-centred counseling style for eliciting behaviour change by helping clients to explore and resolve ambivalence" (Miller 1983, cited in a Cochrane report by Lindson-Hawley, N et al., 2015). The 2015 Cochrane review concluded that MI may help people to quit smoking, but underlined at the same time that there were huge variations in study quality and intervention implementations. To our knowledge, a MI-based smoking cessation program has to a very limited extent been tried in a hospital setting before.

The program includes a cessation kit with a few samples of different smoking cessation drugs (nicotine replacement therapy) and consists of at least four individual counselling sessions (30-60 min) and follow up as needed during six months with a trained smoking cessation counsellor. Counselling will take place at the hospital premises, in conjunction with scheduled cancer treatment sessions for the patients.

In the current study, two nurses or radiation therapists at each of the included hospitals will receive training in using MI in smoking cessation counselling. The Norwegian Directorate of Health's standard smoking cessation program based on MI will be modified to be appropriate for cancer patients in treatment. The Norwegian Cancer Society (NCS) will be responsible for the training and the adaptation of the program. NCS will cover on average a 50 percent position designated smoking cessation counselling at each cancer ward. Counselling (one to one counselling) will take place in connection with cancer treatment appointments, before or after (preferably before as patients might feel unwell or nauseas after treatment), except for the first appointment that will happen before cancer treatment starts. Each counselling session will last for approximately 30-60 minutes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital
      • Bodø, Norway, 8092
        • Nordlandssykehuset
      • Kristiansand, Norway
        • Sørlandet Hospital
      • Oslo, Norway
        • Oslo University Hospital
      • Trondheim, Norway
        • St. Olavs Hospital
      • Ålesund, Norway
        • Ålesund Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed cancer patients
  • Offered radiation, chemo or immuno therapy in a designated hospitals
  • Current smokers or recent quitters (within the last six weeks)
  • 18 years or older

Exclusion Criteria:

  • Survival prognosis less than 12 months
  • Suffering dementia or other mental illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Newly diagnosed cancer patients at their first consultation for treatment at an oncological hospital Department, who report to be smoking, recruited from 15/09/17 to 15/3/18. Their smoking status will be observed over a period of six months.
Experimental: Intervention group
Newly diagnosed cancer patients at their first consultation for treatment at an oncological hospital Department, who report to be smoking, recruited from 15/09/18 to 15/3/19. The intervention group will receive structured smoking cessation counselling based on MI and adapted for the cancer setting combined with provision of smoking cessation medication (nicotine replacement therapy) while in the control group there will be standard care which may vary from hospital to hospital. Their smoking status will be observed over a period of six months.
Behavioral: Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medication
structured smoking cessation counselling based on MI and adapted for the cancer setting eventually combined with provision of smoking cessation medication

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Smoking status
Time Frame: After 6 months
Daily, occasional or no smoking
After 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian Institute of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oslo University Hospital
University Hospital of North Norway
Helse Stavanger HF
Sorlandet Hospital HF
St. Olavs Hospital
Norwegian Cancer Society
Helse Møre og Romsdal HF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NorwegianIPH-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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