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临床试验/NCT03328962
NCT03328962Unknown不适用

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

Norwegian Institute of Public Health8 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2017年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
8
主要终点
Smoking status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

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

结局指标

主要结局

Smoking status

时间窗: After 6 months

Daily, occasional or no smoking

次要结局

未报告次要终点

研究者

发起方
Norwegian Institute of Public Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Arnfinn Helleve

Researcher

Norwegian Institute of Public Health

研究点 (8)

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