Condition or disease | Intervention/treatment | Phase |
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Carcinoma In Situ Current Smoker Malignant Neoplasm Primary Neoplasm Recurrent Neoplasm | Other: Behavioral, Psychological or Informational Intervention Drug: Nicotine Replacement Other: Quality-of-Life Assessment Other: Survey Administration Other: Tobacco Cessation Counseling | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 418 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0" |
Actual Study Start Date : | April 11, 2019 |
Estimated Primary Completion Date : | February 1, 2024 |
Estimated Study Completion Date : | February 1, 2029 |
Arm | Intervention/treatment |
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Active Comparator: Arm A (smoking assessment, quitting advice, Quitline referral)
Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.
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Other: Behavioral, Psychological or Informational Intervention
Receive information about tobacco cessation
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment
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Experimental: Arm B (virtual counseling sessions, NRT)
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 NRT (patch and lozenge combined or alone).
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Drug: Nicotine Replacement
Given NRT patch or lozenge (or both)
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment
Other: Survey Administration Ancillary studies
Other: Tobacco Cessation Counseling Receive virtual tobacco cessation counseling
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patient must have telephone, web and e-mail access.
Exclusion Criteria:
Principal Investigator: | Elyse Park | ECOG-ACRIN Cancer Research Group |
Tracking Information | |||||
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First Submitted Date ICMJE | January 8, 2019 | ||||
First Posted Date ICMJE | January 18, 2019 | ||||
Last Update Posted Date | May 21, 2020 | ||||
Actual Study Start Date ICMJE | April 11, 2019 | ||||
Estimated Primary Completion Date | February 1, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO) [ Time Frame: At 6 months ] Will define 7-day point-prevalence by saliva cotinine (< 15 ng/ml) or expired air CO (< 10 ppm). All participants who report being quit and no nicotine replacement (NRT) or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. Chi-square tests will be used to compare the outcomes between treatment groups.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices | ||||
Official Title ICMJE | Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0" | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
418 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 1, 2029 | ||||
Estimated Primary Completion Date | February 1, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03808818 | ||||
Other Study ID Numbers ICMJE | EAQ171CD NCI-2018-02826 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) EAQ171CD ( Other Identifier: ECOG-ACRIN Cancer Research Group ) ECOG-ACRIN-EAQ171CD ( Other Identifier: DCP ) EAQ171CD ( Other Identifier: CTEP ) R01CA214427 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ) | ||||
Study Sponsor ICMJE | ECOG-ACRIN Cancer Research Group | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | Eastern Cooperative Oncology Group | ||||
Verification Date | May 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |