Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT00002520
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Study Overview
Official Title:
Brief Physician-Initiated Quit Smoking Strategies for Clinical Oncology Settings
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
PROJECTED ACCRUAL: A total of 494 patients will be accrued for this study.
* 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.
PROJECTED ACCRUAL: A total of 494 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA021115 | NIH | None | https://reporter.nih.gov/quic… | View |
| E-1Y92 | None | None | View | |
| NCI-P93-0042 | None | None | View |