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Carcinoma In SituNCT03808818

Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices

A study testing Behavioral, Psychological or Informational Intervention, Nicotine Replacement and Quality-of-Life Assessment in people with Carcinoma In Situ and Current Smoker, run by ECOG-ACRIN Cancer Research Group at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Behavioral, Psychological or Informational Intervention, Nicotine Replacement and Quality-of-Life Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
42 sitesUnited States
Study dates
1 Aug 2019to 31 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • STAFF ELIGIBILITY CRITERIA:
  • Must be English speaking.
  • Must be employed at NCI Community Oncology Research Program (NCORP) site for at least three months.
  • PATIENT ELIGIBILITY CRITERIA STEP 0:
  • Patient presenting with any type of cancer with a date of diagnosis within the past 4 months. Recurrence, diagnosed within the last 4 months, of tumors in patients with past cancer diagnoses will be considered eligible. Patients with a new primary cancer, diagnosed within the last 4 months, who have been treated previously for other types of cancer will also be considered eligible. ?In situ? cancers, diagnosed within the past 4 months, will also be considered eligible.
  • Patient must be a current smoker. Current smoker is defined as any cigarette smoking (even a puff) in the past 30 days.
Show all 11Show fewer
  • Patient must be fluent in both, written and spoken, English or both, written and spoken, Spanish.
  • Patient must have telephone, e-mail access, and have access to the internet with a camera-enabled device (e.g., smartphone, tablet, computer, laptop with a webcam/camera)
  • NOTE: The restriction to those with web and e-mail access is based on the primary intention of the study; to assess the implementation of the virtual intervention in the NCORP network.
  • ELIGIBILITY CRITERIA STEP 1: Patient must still meet all criteria outlined in step 0.
  • ELIGIBILITY STEP 2 (RANDOMIZATION): Patient must have completed baseline survey in Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group Systems for Easy Entry of Patient Reported Outcomes (EASEEPRO) within 1 month (30 days) of the date of informed consent (Step 1).

Who cannot join

  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above, or is deemed medically unable to participate by study investigators or oncology clinician (i.e., referral to hospice).
  • Patient has no intention to receive their cancer care or monitoring at an NCORP community cancer site.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Northside Hospital

    Atlanta, Georgia, 30342

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Unity Hospital

    Fridley, Minnesota, 55432

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Freeman Health System

    Joplin, Missouri, 64804

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Baptist Memorial Hospital for Women

    Memphis, Tennessee, 38120

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • HSHS Saint Nicholas Hospital

    Sheboygan, Wisconsin, 53081

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

  • Prisma Health Cancer Institute - Spartanburg

    Spartanburg, South Carolina, 29307

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Carle Cancer Center

    Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Behavioral, Psychological or Informational Intervention, Nicotine Replacement, Quality-of-Life Assessment, Survey Administration, Tobacco Cessation Counseling
Medical subject headings
Carcinoma in Situ, Neoplasms, Recurrence, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral, Psychological or Informational InterventionOther

    Receive information about tobacco cessation

  • Nicotine ReplacementDrug

    Also called Nicotine Replacement Therapy, NRT

    Given NRT patch or lozenge (or both)

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

  • Tobacco Cessation CounselingOther

    Receive virtual tobacco cessation counseling

Study groups in NCT03808818
Study groupRoleWhat they receive
Arm A (smoking assessment, quitting advice, Quitline referral)Active comparatorPatients 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.
Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Quality-of-Life Assessment
Arm B (virtual counseling sessions, NRT)ExperimentalPatients 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).
Receives: Drug: Nicotine Replacement; Other: Quality-of-Life Assessment; Other: Survey Administration; Other: Tobacco Cessation Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)

    We 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 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.

    COVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.

    Measured: At 6 months

Secondary outcomes (7)

  1. Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated)

    We 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 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.

    COVID-19 restrictions prevented any saliva or CO sample collection or analysis as part of this study. Therefore, no biochemical outcome results are available for reporting for this aim.

    Measured: At 3 months

  2. 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report

    7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.

    Measured: At 6 months

  3. 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report

    7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.

    Measured: At 3 months

  4. Self-reported Continuous Tobacco Abstinence

    Continued cessation of cigarette use was analyzed by comparing 3- and 6-month 7-day point prevalence in smoking cessation.

    If participants withdrew or did not answer the survey, they were marked as having recently smoked. Thus, participants needed to complete the survey and indicate that they had stopped tobacco use at both 3- and 6-month timepoints to be identified as having continuous cessation.

    Measured: At 3months and 6 months

  5. Sustained Tobacco Abstinence at 6 Months (Not Evaluated)

    To qualify as a sustained abstinence at 6 months, the participant must qualify as biochemically-verified 7-day point prevalence cigarette abstinence at 3 and 6 months. Chi-square tests will be used to compare the outcomes between treatment groups.

    COVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.

    Measured: At 6 months

  6. Significant Reduction in Smoking

    Significant reduction in daily smoking from baseline to 6 months was defined as > 50% reduction in reported number of cigarettes per day.

    Patients were ask to report the average number of cigarettes smoked per day on the 6mo and baseline surveys.

    if Xb is the average number smoked at baseline and X6 is the average number smoked at 6 months Then the reduction was calculated as (Xb-X6)/Xb

    Measured: baseline and 6 months

  7. Significant Reduction in Smoking @ 3 Months

    Significant reduction in daily smoking from baseline to 6 months was defined as > 50% reduction in reported number of cigarettes per day.

    Patients were ask to report the average number of cigarettes smoked per day on the 3mo and baseline surveys.

    if Xb is the average number smoked at baseline and X3 is the average number smoked at 3 months Then the reduction was calculated as (Xb-X3)/Xb

    Measured: baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start1 Aug 2019
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03808818
Sponsor's protocol ID
EAQ171CD
Other IDs
NCI-2018-02826, EAQ171CD, ECOG-ACRIN-EAQ171CD, EAQ171CD, R01CA214427
Status last verified
Mar 2025
First submitted
8 Jan 2019
Last updated
18 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Park ER, Sicks JD, Goshe BM, Gareen IF, Herman BA, Taurone A, Bittig S, Walter AW, Regan S, Rosen R, Durieux N, Rasmussen AW, Levy DE, Nicolosi G, Muzikansky A, Thompson MA, Lui M, Malloy L, Gonzalez I, Finkelstein-Fox L, Munson ND, Greenwade MM, King DM, Jenigiri B, Burnette BL, Throckmorton AD, Tingen MS, Carlos RC, Wagner LI, Ostroff JS. Virtual Sustained Tobacco Treatment for Patients With Cancer: A Randomized Controlled Trial (ECOG-ACRIN: EAQ171CD) Within the National Cancer Institute Community Oncology Research Program. J Clin Oncol. 2026 Aug 20;44(24):2303-2315. doi: 10.1200/JCO-25-02267. Epub 2026 Jul 13.

    PubMed 42441935

  • Goshe BM, Rasmussen AW, Wagner LI, Sicks JD, Gareen IF, Carlos RC, Herman BA, Walter AW, Regan S, Levy DE, Mahon I, Muzikansky A, Neil JM, Lui M, Dilip D, Malloy L, Gonzalez I, Finkelstein-Fox L, McCann C, Perez E, Ostroff JS, Park ER. 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. 2022 Jul 15;22(1):1359. doi: 10.1186/s12889-022-13631-w.

    PubMed 35841024

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral, Psychological or Informational Intervention, Nicotine Replacement and Quality-of-Life Assessment in people with Carcinoma In Situ and Current Smoker, run by ECOG-ACRIN Cancer Research Group at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated) (time frame: At 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03808818, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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