Any Cancer

EAQ171CD



Smoke Free Support Study 2.0

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.
  • STAFF ELIGIBILITY CRITERIA: Must be English speaking

  • STAFF ELIGIBILITY CRITERIA: Must be employed at National Cancer Institute (NCI) Community Oncology Research Program (NCORP) site for at least three months

  • PATIENT ELIGIBILITY CRITERIA STEP 0 AND STEP 1: Age >= 18 years

  • 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 ELIGIBILITY CRITERIA STEP 0 AND STEP 1: Patient must be a current smoker. Current smoker is defined as any cigarette smoking (even a puff) in the past 30 days

  • PATIENT ELIGIBILITY CRITERIA STEP 0 AND STEP 1: Patient must be fluent in both, written and spoken, English or both, written and spoken, Spanish

  • PATIENT ELIGIBILITY CRITERIA STEP 0 AND STEP 1: Patient must have telephone, web and electronic (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

  • PATIENT ELIGIBILITY CRITERIA STEP 0 AND STEP 1: 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 ELIGIBILITY CRITERIA STEP 0 AND STEP 1: Patient has no intention to receive their cancer care or monitoring at an NCORP community cancer site

  • 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)

United States
AK
Anchorage
Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org

GA
Atlanta
Northside Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalTrials@northside.com

Augusta
Augusta University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ga_cares@augusta.edu

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Email: underberga@sjchs.org

IA
Cedar Rapids
Physicians' Clinic of Iowa PC
Status: ACTIVE
Contact: Site Public Contact

Des Moines
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact

IL
Chicago
John H Stroger Jr Hospital of Cook County
Status: ACTIVE
Contact: Site Public Contact

Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact

Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

MN
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact

MS
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Status: ACTIVE
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

NC
Gastonia
CaroMont Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: tammy.cozad@caromonthealth.org

Hendersonville
Margaret R Pardee Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: karen.morris@unchealth.unc.edu

NY
Bronx
Montefiore Medical Center - Moses Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Einstein Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: eskwak@montefiore.org

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: nr2616@cumc.columbia.edu

OH
Belpre
Strecker Cancer Center-Belpre
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marietta
Marietta Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marion
OhioHealth Marion General Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact

Easley
Prisma Health Cancer Institute - Easley
Status: ACTIVE
Contact: Site Public Contact
Email: Kim.Williams3@prismahealth.org

Greenville
Prisma Health Cancer Institute - Butternut
Status: ACTIVE
Contact: Site Public Contact

Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact

Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact

Greer
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact

Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact

TN
Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: ACTIVE
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Baptist Memorial Hospital for Women
Status: ACTIVE
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

WI
Appleton
ThedaCare Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Green Bay
Aurora BayCare Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ncorp@aurora.org

Saint Vincent Hospital Cancer Center Green Bay
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Sheboygan
HSHS Saint Nicholas Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Weston
Marshfield Medical Center - Weston
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

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 (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 (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.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its NCI Community Oncology Research Program (NCORP).


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