Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT03808818
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2019-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Study Overview
Official Title:
Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"
Status:
COMPLETED
Status Verified Date:
2025-03
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:
This phase II trial studies how well smoking cessation treatment plans work in tobacco-dependent cancer patients when delivered virtually as part of their cancer care in community oncology practices. Virtual information and counseling sessions may help cancer patients quit smoking.
Detailed Description:
PRIMARY OBJECTIVE:
I. To compare the proportions of participants in the Enhanced Usual Care (EUC) and Virtual Tobacco Treatment (VIT) study arms with biochemically-verified 7-day point-prevalence abstinence from cigarettes at 6-months post enrollment.
SECONDARY OBJECTIVES:
I. Biochemically-verified 7-day point prevalence abstinence at 3-months follow-up.
II. Self-reported 7-day point prevalence cigarette abstinence at 3- and 6-months follow-up.
III. Significant reduction (\> 50% reduction in reported number of cigarettes per day) in daily smoking from baseline to 3- and baseline to 6-months follow-up.
IV. Continuous (no self-reported smoking since last survey point) and sustained abstinence at 6 months (cotinine-verified at 3-months and 6-months).
EXPLORATORY OBJECTIVES:
I. To assess the potential effect of known and potential moderators on treatment effectiveness between the two arms.
II. To assess the processes of implementation and dissemination (acceptability, adoption, appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and sustainability) of the investigator's intervention at community oncology sites.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (Enhanced Usual Care \[EUC\]): Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the National Cancer Institute (NCI) Smoking Quitline.
ARM B (Virtual Intervention Treatment \[VIT\]): Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of nicotine replacement (NRT) (patch and lozenge combined or alone).
After completion of study, patients may be followed up for 1 year.
I. To compare the proportions of participants in the Enhanced Usual Care (EUC) and Virtual Tobacco Treatment (VIT) study arms with biochemically-verified 7-day point-prevalence abstinence from cigarettes at 6-months post enrollment.
SECONDARY OBJECTIVES:
I. Biochemically-verified 7-day point prevalence abstinence at 3-months follow-up.
II. Self-reported 7-day point prevalence cigarette abstinence at 3- and 6-months follow-up.
III. Significant reduction (\> 50% reduction in reported number of cigarettes per day) in daily smoking from baseline to 3- and baseline to 6-months follow-up.
IV. Continuous (no self-reported smoking since last survey point) and sustained abstinence at 6 months (cotinine-verified at 3-months and 6-months).
EXPLORATORY OBJECTIVES:
I. To assess the potential effect of known and potential moderators on treatment effectiveness between the two arms.
II. To assess the processes of implementation and dissemination (acceptability, adoption, appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and sustainability) of the investigator's intervention at community oncology sites.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (Enhanced Usual Care \[EUC\]): Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the National Cancer Institute (NCI) Smoking Quitline.
ARM B (Virtual Intervention Treatment \[VIT\]): Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of nicotine replacement (NRT) (patch and lozenge combined or alone).
After completion of study, patients may be followed up for 1 year.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: