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Smoking Cessation in Cancer Treatment

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03328962
Enrollment
1200
Registered
2017-11-01
Start date
2017-09-15
Completion date
2021-06-30
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motivation, Smoking Cessation

Brief 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.

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.

Interventions

BEHAVIORALStructured 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

Sponsors

Norwegian Cancer Society
CollaboratorOTHER
Helse Stavanger HF
CollaboratorOTHER_GOV
Oslo University Hospital
CollaboratorOTHER
Sorlandet Hospital HF
CollaboratorOTHER_GOV
University Hospital of North Norway
CollaboratorOTHER
Helse Møre og Romsdal HF
CollaboratorOTHER_GOV
St. Olavs Hospital
CollaboratorOTHER
Norwegian Institute of Public Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking statusAfter 6 monthsDaily, occasional or no smoking

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026