NCT03328962

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

October 23, 2017

Last Update Submit

August 20, 2019

Conditions

Smoking CessationMotivation

Outcome Measures

Primary Outcomes (1)

  • Smoking status

    Daily, occasional or no smoking

    After 6 months

Study Arms (2)

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.

Behavioral: Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medication

Interventions

Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medicationBEHAVIORAL

structured smoking cessation counselling based on MI and adapted for the cancer setting eventually combined with provision of smoking cessation medication

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ålesund Hospital

Ålesund, Norway

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Nordlandssykehuset

Bodø, 8092, Norway

Location

Sørlandet Hospital

Kristiansand, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 23, 2017

First Posted

November 1, 2017

Study Start

September 15, 2017

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

NO(6)