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Nicotine Replacement

Virtual Tobacco Treatment for Cancer Patients

Phase 2
Waitlist Available
Led By Elyse Park
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial looks at how well cancer patients are able to quit smoking when given a smoking cessation treatment plan delivered online or over the phone.

Who is the study for?
This trial is for cancer patients who smoke, diagnosed within the last 4 months, including those with recurrences or new primary cancers. Participants must have web and email access, speak English or Spanish fluently, and intend to receive care at an NCORP site. Excluded are those not planning to get care at NCORP sites, with poor performance status (ECOG ≥3), or referred to hospice.Check my eligibility
What is being tested?
The study tests virtual smoking cessation treatments for tobacco-dependent cancer patients in community oncology practices. It includes virtual counseling sessions and may involve nicotine replacement therapy as well as assessments of quality of life and surveys.See study design
What are the potential side effects?
While specific side effects are not listed for this behavioral intervention trial, potential side effects could include irritation from nicotine replacement products if used, stress or anxiety during cessation attempts, and possible withdrawal symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO)
Secondary outcome measures
Cotinine
Self-reported 7-day point prevalence abstinence
Self-reported continuous tobacco abstinence
+1 more
Other outcome measures
Implementation of the intervention at community oncology sites
Intervention acceptability (satisfaction with content/delivery) at community oncology sites
Intervention adoption (program uptake) at community oncology sites
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (virtual counseling sessions, NRT)Experimental Treatment4 Interventions
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).
Group II: Arm A (smoking assessment, quitting advice, Quitline referral)Active Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Replacement
2019
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,507 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,252 Total Patients Enrolled
2 Trials studying Smokers
1,250 Patients Enrolled for Smokers
Elyse ParkPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Nicotine Replacement (Nicotine Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT03808818 — Phase 2
Smokers Research Study Groups: Arm A (smoking assessment, quitting advice, Quitline referral), Arm B (virtual counseling sessions, NRT)
Smokers Clinical Trial 2023: Nicotine Replacement Highlights & Side Effects. Trial Name: NCT03808818 — Phase 2
Nicotine Replacement (Nicotine Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808818 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are the researchers limiting this research to?

"This clinical trial requires 418 suitable participants. Those looking to take part can do so at the Prisma Health Cancer Institute - Spartanburg in South carolina and/or the Prisma Health Cancer Institution - Butternut situated in Greenville, Minnesota."

Answered by AI

How many medical facilities have implemented this research?

"This clinical trial is presently open for enrollment at 38 medical sites. These locations are spread across Spartanburg, Greenville and Seneca as well as other cities around the United States of America. To reduce your travel commitment, it's important to select a site close by when enrolling."

Answered by AI

Has the FDA sanctioned any Nicotine Replacement therapies?

"Considering the Phase 2 status of this clinical trial, there is evidence to suggest nicotine replacement therapy's safety but no proof that it works. Therefore, we gave it a score of 2 on our scale from 1-3."

Answered by AI

Are there vacancies available for prospective test subjects in this experiment?

"According to information located on clinicaltrials.gov, this medical experiment is currently enrolling participants. Since its initial posting on April 11th 2019, it has been regularly updated as recently as November 15th 2022."

Answered by AI

Are there any prior investigations into Nicotine Replacement therapies?

"In 2006, the University of Hong Kong began studying nicotine replacement therapy. After 557 completed studies, there are presently 71 ongoing clinical trials across Spartanburg, South carolina and beyond that focus on this particular area of research."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
Wisconsin
South Carolina
What site did they apply to?
Medical Oncology and Hematology Associates-Des Moines
Prisma Health Cancer Institute - Spartanburg
HSHS Saint Nicholas Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0

Why did patients apply to this trial?

Recent research and studies
BMC Public HealthJournal
Study Protocol for a Hybrid Type 1 Effectiveness-implementation Trial Testing Virtual Tobacco Treatment in Oncology Practices [smokefree Support Study 2.0]
Goshe, Brett M., Autumn W. Rasmussen, Lynne I. Wagner, JoRean D. Sicks, Ilana F. Gareen, Ruth C. Carlos, Benjamin A. Herman, et al.. 2022. “Study Protocol for a Hybrid Type 1 Effectiveness-implementation Trial Testing Virtual Tobacco Treatment in Oncology Practices [smokefree Support Study 2.0]”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-022-13631-w.
clinicaltrials.govStudy
Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
2019. "Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03808818.
~73 spots leftby Apr 2025
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