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Smoke Free Support Study 2.0

Trial Status: Active

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.

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 AND STEP 1:
  • 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, web and 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. * The requirement to register within 4 months from cancer diagnosis is determined by the date of the step 0 registration and not the date of the step 1 registration
  • 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.

Alaska

Anchorage
Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

Georgia

Atlanta
Northside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-303-3355
Augusta
Augusta University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 706-721-2388
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-864-5204
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532

Iowa

Cedar Rapids
Physicians' Clinic of Iowa PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 319-297-2900
Des Moines
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921

Minnesota

Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Mississippi

Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366

Missouri

Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Einstein Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-305-6361

North Carolina

Gastonia
CaroMont Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 704-834-2810
Hendersonville
Margaret R Pardee Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 828-696-4716

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Marietta
Marietta Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Marion
OhioHealth Marion General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118

South Carolina

Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Easley
Prisma Health Cancer Institute - Easley
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Greenville
Prisma Health Cancer Institute - Butternut
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Greer
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251
Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-241-6251

Tennessee

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Baptist Memorial Hospital for Women
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366

Washington

Auburn
MultiCare Auburn Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-887-9333
Gig Harbor
MultiCare Gig Harbor Medical Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-2394
Puyallup
MultiCare Good Samaritan Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-351-7955
Tacoma
MultiCare Tacoma General Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-3229

Wisconsin

Appleton
ThedaCare Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-364-3605
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Green Bay
Aurora BayCare Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Saint Vincent Hospital Cancer Center Green Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Sheboygan
HSHS Saint Nicholas Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Weston
Marshfield Medical Center - Weston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581

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 our 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.

Trial Phase Phase II

Trial Type Health services research

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Elyse Park

  • Primary ID EAQ171CD
  • Secondary IDs NCI-2018-02826, ECOG-ACRIN-EAQ171CD
  • Clinicaltrials.gov ID NCT03808818