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

NCT ID: NCT03808818

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2023-12-31

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.

Conditions

Carcinoma In Situ; Current Smoker; Malignant Neoplasm; Primary Neoplasm; Recurrent Neoplasm; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Behavioral, Psychological or Informational Intervention

Intervention Type: OTHER

Receive information about tobacco cessation

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

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).

Group Type: EXPERIMENTAL

Nicotine Replacement

Intervention Type: DRUG

Given NRT patch or lozenge (or both)

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Survey Administration

Intervention Type: OTHER

Ancillary studies

Tobacco Cessation Counseling

Intervention Type: OTHER

Receive virtual tobacco cessation counseling

Interventions

Behavioral, Psychological or Informational Intervention

Receive information about tobacco cessation

Intervention Type: OTHER

Nicotine Replacement

Given NRT patch or lozenge (or both)

Intervention Type: DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Tobacco Cessation Counseling

Receive virtual tobacco cessation counseling

Intervention Type: OTHER

Other Intervention Names

Nicotine Replacement Therapy; NRT; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• 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.
• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elyse Park

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Northside Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Carle on Vermilion

Danville, Illinois, United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Unity Hospital

Fridley, Minnesota, United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Freeman Health System

Joplin, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

CaroMont Regional Medical Center

Gastonia, North Carolina, United States

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Marietta Memorial Hospital

Marietta, Ohio, United States

OhioHealth Marion General Hospital

Marion, Ohio, United States

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Prisma Health Cancer Institute - Spartanburg

Spartanburg, South Carolina, United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

Baptist Memorial Hospital for Women

Memphis, Tennessee, United States

MultiCare Auburn Medical Center

Auburn, Washington, United States

MultiCare Gig Harbor Medical Park

Gig Harbor, Washington, United States

MultiCare Good Samaritan Hospital

Puyallup, Washington, United States

MultiCare Tacoma General Hospital

Tacoma, Washington, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, United States

HSHS Saint Nicholas Hospital

Sheboygan, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35841024 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

EAQ171CD

Identifier Type: -

Identifier Source: org_study_id

NCI-2018-02826

Identifier Type: REGISTRY

Identifier Source: secondary_id

EAQ171CD

Identifier Type: OTHER

Identifier Source: secondary_id

ECOG-ACRIN-EAQ171CD

Identifier Type: OTHER

Identifier Source: secondary_id

EAQ171CD

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA214427

Identifier Type: NIH

Identifier Source: secondary_id

View Link