Any Cancer
EAQ171CD
Smoke Free Support Study 2.0
STATUS: Closed to Accrual and Intervention
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. āIn situā 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
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org
GA
Atlanta
Northside Hospital
Contact: Site Public Contact
Email: ClinicalTrials@northside.com
Augusta
Augusta University Medical Center
Contact: Site Public Contact
Email: ga_cares@augusta.edu
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Contact: Site Public Contact
Email: underberga@sjchs.org
IA
Cedar Rapids
Physicians' Clinic of Iowa PC
Contact: Site Public Contact
Des Moines
Iowa Methodist Medical Center
Contact: Site Public Contact
Mission Cancer and Blood - Des Moines
Contact: Site Public Contact
IL
Chicago
John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact
Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@carle.com
Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact
Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com
MN
Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
MO
Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com
Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com
Springfield
CoxHealth South Hospital
Contact: Site Public Contact
MS
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
NC
Gastonia
CaroMont Regional Medical Center
Contact: Site Public Contact
Email: tammy.cozad@caromonthealth.org
Hendersonville
Margaret R Pardee Memorial Hospital
Contact: Site Public Contact
NY
Bronx
Montefiore Medical Center - Moses Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org
Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Contact: Site Public Contact
Email: nr2616@cumc.columbia.edu
OH
Belpre
Strecker Cancer Center-Belpre
Contact: Site Public Contact
Email: sheree@columbusccop.org
Marietta
Marietta Memorial Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org
Marion
OhioHealth Marion General Hospital
Contact: Site Public Contact
Email: sheree@columbusccop.org
Portsmouth
Southern Ohio Medical Center
Contact: Site Public Contact
Email: sheree@columbusccop.org
SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Contact: Site Public Contact
Easley
Prisma Health Cancer Institute - Easley
Contact: Site Public Contact
Email: Kim.Williams3@prismahealth.org
Greenville
Prisma Health Cancer Institute - Butternut
Contact: Site Public Contact
Prisma Health Cancer Institute - Eastside
Contact: Site Public Contact
Prisma Health Cancer Institute - Faris
Contact: Site Public Contact
Greer
Prisma Health Cancer Institute - Greer
Contact: Site Public Contact
Seneca
Prisma Health Cancer Institute - Seneca
Contact: Site Public Contact
TN
Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
Baptist Memorial Hospital for Women
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
WA
Auburn
MultiCare Auburn Medical Center
Contact: Site Public Contact
Email: research@multicare.org
Gig Harbor
MultiCare Gig Harbor Medical Park
Contact: Site Public Contact
Email: research@multicare.org
Puyallup
MultiCare Good Samaritan Hospital
Contact: Site Public Contact
Email: research@multicare.org
Tacoma
MultiCare Tacoma General Hospital
Contact: Site Public Contact
Email: research@multicare.org
WI
Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Saint Vincent Hospital Cancer Center Green Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
Saint Vincent Hospital Cancer Center at Saint Mary's
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
Sheboygan
HSHS Saint Nicholas Hospital
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
Weston
Marshfield Medical Center - Weston
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).