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

NCT03808818 | Completed Results DMC

• 4 other identifiers: EAQ171CDNCI-2018-02826ECOG-ACRIN-EAQ171CDR01CA214427
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 42

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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  At 6 months

Secondary Outcomes (7)

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

  At 3 months

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

  At 6 months

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

  At 3 months

• Self-reported Continuous Tobacco Abstinence

  At 3months and 6 months

• Sustained Tobacco Abstinence at 6 Months (Not Evaluated)

  At 6 months

Other Outcomes (16)

• Potential Effect of Sociodemographics on Treatment Effectiveness

  Up to 6 months

• Potential Effect of Medical and Smoking History on Treatment Effectiveness

  Up to 6 months

• Potential Effect of Cancer Variables on Treatment Effectiveness

  Up to 6 months

Study Arms (2)

Arm A (smoking assessment, quitting advice, Quitline referral)

ACTIVE COMPARATOR

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.

Other: Behavioral, Psychological or Informational Intervention; Other: Quality-of-Life Assessment

Arm B (virtual counseling sessions, NRT)

EXPERIMENTAL

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).

Drug: Nicotine Replacement; Other: Quality-of-Life Assessment; Other: Survey Administration; Other: Tobacco Cessation Counseling

Interventions

Behavioral, Psychological or Informational Intervention OTHER

Receive information about tobacco cessation

Arm A (smoking assessment, quitting advice, Quitline referral)

Nicotine Replacement DRUG

Given NRT patch or lozenge (or both)

Also known as: Nicotine Replacement Therapy, NRT

Arm B (virtual counseling sessions, NRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (smoking assessment, quitting advice, Quitline referral); Arm B (virtual counseling sessions, NRT)

Survey Administration OTHER

Ancillary studies

Arm B (virtual counseling sessions, NRT)

Tobacco Cessation Counseling OTHER

Receive virtual tobacco cessation counseling

Arm B (virtual counseling sessions, NRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (42)

Alaska Women's Cancer Care

Anchorage, Alaska, 99508, United States

Location

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Carle on Vermilion

Danville, Illinois, 61832, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, 52402, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

CaroMont Regional Medical Center

Gastonia, North Carolina, 28054, United States

Location

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Strecker Cancer Center-Belpre

Belpre, Ohio, 45714, United States

Location

Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

OhioHealth Marion General Hospital

Marion, Ohio, 43302, United States

Location

Southern Ohio Medical Center

Portsmouth, Ohio, 45662, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Prisma Health Cancer Institute - Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

Location

Baptist Memorial Hospital for Women

Memphis, Tennessee, 38120, United States

Location

MultiCare Auburn Medical Center

Auburn, Washington, 98001, United States

Location

MultiCare Gig Harbor Medical Park

Gig Harbor, Washington, 98335, United States

Location

MultiCare Good Samaritan Hospital

Puyallup, Washington, 98372, United States

Location

MultiCare Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

HSHS Saint Nicholas Hospital

Sheboygan, Wisconsin, 53081, United States

Location

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495, United States

Location

Related Publications (1)

• 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.

  PMID: 35841024 DERIVED

MeSH Terms

Conditions

Carcinoma in Situ; Neoplasms; Recurrence; Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG-ACRIN Statistical Office

eatrials@jimmy.harvard.edu

617-632-3012

Study Officials

• Elyse Park

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 18, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-03

Locations

US (42)