Clinical trial NCT03808818: Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
Official title: Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma In Situ
Current Smoker
Malignant Neoplasm
Primary Neoplasm
Recurrent Neoplasm
Smoking Cessation
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-01-18
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)
timeFrame: At 6 months
Secondary outcomes:
measure: Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated)
timeFrame: At 3 months
measure: 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report
timeFrame: At 6 months
measure: 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report
timeFrame: At 3 months
measure: Self-reported Continuous Tobacco Abstinence
timeFrame: At 3months and 6 months
measure: Sustained Tobacco Abstinence at 6 Months (Not Evaluated)
timeFrame: At 6 months
measure: Significant Reduction in Smoking
timeFrame: baseline and 6 months
measure: Significant Reduction in Smoking @ 3 Months
timeFrame: baseline and 3 months
Other outcomes:
measure: Potential Effect of Sociodemographics on Treatment Effectiveness
timeFrame: Up to 6 months
measure: Potential Effect of Medical and Smoking History on Treatment Effectiveness
timeFrame: Up to 6 months
measure: Potential Effect of Cancer Variables on Treatment Effectiveness
timeFrame: Up to 6 months
measure: Implementation of the Intervention at Community Oncology Sites
timeFrame: Up to 36 months
measure: Intervention Acceptability (Satisfaction With Content/Delivery) at Community Oncology Sites
timeFrame: Up to 36 months
measure: Intervention Adoption (Program Uptake) at Community Oncology Sites
timeFrame: Up to 36 months
measure: Intervention Appropriateness (Relevance) at Community Oncology Sites
timeFrame: Up to 36 months
measure: Intervention Cost at Community Oncology Sites
timeFrame: Up to 36 months
measure: Treatment Fidelity/Adaptation at Community Oncology Sites
timeFrame: Up to 36 months
measure: Intervention Penetration (Reach) at Community Oncology Sites
timeFrame: Up to 36 months
measure: Intervention Sustainability at Community Oncology Sites
timeFrame: Up to 36 months
measure: Acceptability: Needs Were Met
timeFrame: 6-months
measure: Acceptability: Assistance Support
timeFrame: 6-months
measure: Acceptability: Helpfulness of Study
timeFrame: 6-months
measure: Acceptability: Quality of Assistance
timeFrame: 6-months
measure: Acceptability: Would Recommend Study to Friends
timeFrame: 6-months
Locations:
city: Anchorage
country: United States
facility: Alaska Women's Cancer Care
state: Alaska
city: Anchorage
country: United States
facility: Katmai Oncology Group
state: Alaska
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Danville
country: United States
facility: Carle on Vermilion
state: Illinois
city: Mount Vernon
country: United States
facility: Good Samaritan Regional Health Center
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: Physicians' Clinic of Iowa PC
state: Iowa
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates-Des Moines
state: Iowa
city: Fridley
country: United States
facility: Unity Hospital
state: Minnesota
city: Southhaven
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Desoto
state: Mississippi
city: Joplin
country: United States
facility: Freeman Health System
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center
state: Missouri
city: Springfield
country: United States
facility: CoxHealth South Hospital
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: Gastonia
country: United States
facility: CaroMont Regional Medical Center
state: North Carolina
city: Hendersonville
country: United States
facility: Margaret R Pardee Memorial Hospital
state: North Carolina
city: Belpre
country: United States
facility: Strecker Cancer Center-Belpre
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial Hospital
state: Ohio
city: Marion
country: United States
facility: OhioHealth Marion General Hospital
state: Ohio
city: Portsmouth
country: United States
facility: Southern Ohio Medical Center
state: Ohio
city: Easley
country: United States
facility: Prisma Health Cancer Institute - Easley
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Butternut
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Faris
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Eastside
state: South Carolina
city: Greer
country: United States
facility: Prisma Health Cancer Institute - Greer
state: South Carolina
city: Seneca
country: United States
facility: Prisma Health Cancer Institute - Seneca
state: South Carolina
city: Spartanburg
country: United States
facility: Prisma Health Cancer Institute - Spartanburg
state: South Carolina
city: Memphis
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Memphis
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital for Women
state: Tennessee
city: Auburn
country: United States
facility: MultiCare Auburn Medical Center
state: Washington
city: Gig Harbor
country: United States
facility: MultiCare Gig Harbor Medical Park
state: Washington
city: Puyallup
country: United States
facility: MultiCare Good Samaritan Hospital
state: Washington
city: Tacoma
country: United States
facility: MultiCare Tacoma General Hospital
state: Washington
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Saint Mary's
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Oconto Falls
country: United States
facility: Saint Vincent Hospital Cancer Center at Oconto Falls
state: Wisconsin
city: Sheboygan
country: United States
facility: HSHS Saint Nicholas Hospital
state: Wisconsin
city: Sturgeon Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Sturgeon Bay
state: Wisconsin
Study officials:
affiliation: ECOG-ACRIN Cancer Research Group
name: Elyse Park
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.