Smoking CessationNCT03328962
Smoking Cessation in Cancer Treatment
A study testing Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medication in people with Smoking Cessation and Motivation, run by Norwegian Institute of Public Health at 6 sites in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Motivation
- What is being tested?
- Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 6 sitesNorway
- Study dates
- 15 Sep 2017to Jun 2021
- 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
- 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
Who cannot join
- Survival prognosis less than 12 months
- Suffering dementia or other mental illnesses
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
Ålesund Hospital
Ålesund
Haukeland University Hospital
Bergen, 5021
Nordlandssykehuset
Bodø, 8092
Sørlandet Hospital
Kristiansand
Oslo University Hospital
Oslo
St. Olavs Hospital
Trondheim
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Motivation
- Being tested
- Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medication
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medicationBehavioural
structured smoking cessation counselling based on MI and adapted for the cancer setting eventually combined with provision of smoking cessation medication
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Intervention group | Experimental | 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. Receives: Behavioral: Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking status
Daily, occasional or no smoking
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start15 Sep 2017
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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 (intervention program and standard care will be described in details later). The recruitment period for the control group will be from September 2017 to March 2018. Participants in the control group will be invited to answer a follow up questionnaire after 6 months. Six months after the last recruited participant to the control group, i.e. from September 2018, recruitment of participants to the intervention group will begin and last for six months, to the end of February 2019 and the participants in the intervention group will be followed for 6 months, to the end of August 2019. The figure below gives an overview of the timing of recruitment and observations.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Norwegian Cancer Society, Helse Stavanger HF, Oslo University Hospital, Sorlandet Hospital HF, University Hospital of North Norway, Helse Møre og Romsdal HF, St. Olavs Hospital
- Responsible party
- Principal investigator, Arnfinn Helleve, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328962
- Sponsor's protocol ID
- NorwegianIPH-001
- Status last verified
- Aug 2019
- First submitted
- 23 Oct 2017
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03328962
- Acronym / sponsor ID
- NorwegianIPH-001
- Conditions
- Smoking Cessation, Motivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Norwegian Cancer Society, Helse Stavanger HF, Oslo University Hospital, Sorlandet Hospital HF, University Hospital of North Norway, Helse Møre og Romsdal HF, St. Olavs Hospital
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 (intervention program and standard care will be described in details later). The recruitment period for the control group will be from September 2017 to March 2018. Participants in the control group will be invited to answer a follow up questionnaire after 6 months. Six months after the last recruited participant to the control group, i.e. from September 2018, recruitment of participants to the intervention group will begin and last for six months, to the end of February 2019 and the participants in the intervention group will be followed for 6 months, to the end of August 2019. The figure below gives an overview of the timing of recruitment and observations.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Intervention group | Experimental | Behavioral: Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medicationNewly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Survival prognosis less than 12 months
- Suffering dementia or other mental illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medicationstructured smoking cessation counselling based on MI and adapted for the cancer setting eventually combined with provision of smoking cessation medication | Behavioural | Intervention group |
Primary outcome
Smoking status
Time frame: After 6 months
Daily, occasional or no smoking
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medication in people with Smoking Cessation and Motivation, run by Norwegian Institute of Public Health at 6 sites in Norway.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway. 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?
Results are not available in the source record.
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?
Smoking status (time frame: After 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2019.