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临床试验/NCT00002520
NCT00002520已完成不适用

Brief Physician-Initiated Quit Smoking Strategies for Clinical Oncology Settings

Eastern Cooperative Oncology Group1 个研究点 分布在 1 个国家目标入组 434 人开始时间: 1990年12月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
434
试验地点
1
主要终点
Rate of Smoking Cessation at 6 months

研究概览

简要总结

RATIONALE: Physician-initiated smoking cessation strategies may be effective in getting early-stage cancer patients to quit smoking.

PURPOSE: Randomized clinical trial to compare the effectiveness of a physician-initiated stop-smoking program with the usual care for patients receiving treatment for early-stage cancer.

详细描述

OBJECTIVES:

  • Compare the efficacy of brief physician-initiated smoking cessation strategies vs usual care in patients with early stage cancer who are undergoing treatment in clinical oncology settings.
  • Compare the sociodemographic, smoking history, and health status correlates of smoking cessation in patients treated with these regimens.
  • Determine the feasibility of conducting a cancer prevention and control study in a cooperative group setting by monitoring adherence to the smoking-cessation strategies.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive usual care (no special intervention).
  • Arm II: Patients receive smoking-cessation therapy based on the 4-step intervention plan in the "Manual for Physicians" published by the National Cancer Institute. The smoking cessation coordinator and physician provide self-quitting advice and support to the patient via counseling, self-help materials, and referral to a smoking cessation counselor at the Cancer Information Service (CIS). Patients receive nicotine replacement, if indicated. Patients who express an interest in more intensive treatment are referred to local American Cancer Society or American Lung Association clinics and/or advised to call the CIS for additional local program referrals.

All patients are followed at 6 and 12 months. Patients who report that they are still smoking and interested in help to quit smoking at the 12-month follow-up interview are encouraged to return to their physicians and contact the CIS for additional help quitting or for a referral to more intensive or specialized treatments in their area.

研究设计

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

入排标准

年龄范围
19 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Quit Smoking Intervention

Experimental

Patients received advice and help to quit smoking. The intervention employed physician and patient resources that had already been developed and evaluated or pre-tested, including written materials, prescriptions for nicotine replacement, counseling, and follow-up contact.

干预措施: nicotine (Drug)

Usual Care

Active Comparator

No special intervention after randomization. "Usual care" may or may not include advice or assistance to stop smoking. Physicians were reassured that "usual care" did not preclude quit smoking counseling.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Rate of Smoking Cessation at 6 months

时间窗: Assessed at 6 months

Proportion of patients who have quit smoking 6 months after the intervention

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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