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Smoking Cessation in Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03328962
Recruitment Status : Enrolling by invitation
First Posted : November 1, 2017
Last Update Posted : August 21, 2019
Sponsor:
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
Information provided by (Responsible Party):
Arnfinn Helleve, Norwegian Institute of Public Health

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Motivation Behavioral: Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medication Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.

Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Smoking status [ Time Frame: After 6 months ]
    Daily, occasional or no smoking



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328962


Locations
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Norway
Haukeland University Hospital
Bergen, Norway, 5021
Nordlandssykehuset
Bodø, Norway, 8092
Sørlandet Hospital
Kristiansand, Norway
Oslo University Hospital
Oslo, Norway
St. Olavs Hospital
Trondheim, Norway
Ålesund Hospital
Ålesund, Norway
Sponsors and Collaborators
Norwegian Institute of Public Health
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

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Responsible Party: Arnfinn Helleve, Researcher, Norwegian Institute of Public Health
ClinicalTrials.gov Identifier: NCT03328962     History of Changes
Other Study ID Numbers: NorwegianIPH-001
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No