Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002520
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
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 andor 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 andor 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA021115 | NIH | None | None |
| E-1Y92 | None | None | None |
| NCI-P93-0042 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA021115 |