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

Not Applicable

Completed

Conditions: Carcinoma In Situ
Current Smoker
Malignant Neoplasm
Primary Neoplasm
Recurrent Neoplasm
Smoking Cessation

Interventions: Other: Behavioral, Psychological or Informational Intervention
Drug: Nicotine Replacement
Other: Quality-of-Life Assessment
Other: Survey Administration
Other: Tobacco Cessation Counseling

Registration Number: NCT03808818

Lead Sponsor: ECOG-ACRIN Cancer Research Group

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 306

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (smoking assessment, quitting advice, Quitline referral)	Behavioral, Psychological or Informational Intervention	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.
Arm A (smoking assessment, quitting advice, Quitline referral)	Quality-of-Life Assessment	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.
Arm B (virtual counseling sessions, NRT)	Nicotine Replacement	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).
Arm B (virtual counseling sessions, NRT)	Quality-of-Life Assessment	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).
Arm B (virtual counseling sessions, NRT)	Survey Administration	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).
Arm B (virtual counseling sessions, NRT)	Tobacco Cessation Counseling	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).

Primary Outcome Measures

Name	Time	Method
Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)	At 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated)	At 3 months	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 or analysis as part of this study. Therefore, no biochemical outcome results are available for reporting for this aim.
7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report	At 6 months	7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.
7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report	At 3 months	7-day point-prevalence was determined from participant response to the survey question: "How long has it been since you last smoked a cigarette (even one or two puffs)?" If participants withdrew, was lost to follow up, did not answer, or indicated 7 days or less since their last puff, they were marked as having recently smoked.
Self-reported Continuous Tobacco Abstinence	At 3months and 6 months	Continued cessation of cigarette use was analyzed by comparing 3- and 6-month 7-day point prevalence in smoking cessation. If participants withdrew or did not answer the survey, they were marked as having recently smoked. Thus, participants needed to complete the survey and indicate that they had stopped tobacco use at both 3- and 6-month timepoints to be identified as having continuous cessation.
Sustained Tobacco Abstinence at 6 Months (Not Evaluated)	At 6 months	To qualify as a sustained abstinence at 6 months, the participant must qualify as biochemically-verified 7-day point prevalence cigarette abstinence at 3 and 6 months. Chi-square tests will be used to compare the outcomes between treatment groups. COVID-19 restrictions prevented any saliva or CO sample collection. Therefore no biochemical outcome results are available for reporting for this aim.
Significant Reduction in Smoking	baseline and 6 months	Significant reduction in daily smoking from baseline to 6 months was defined as \> 50% reduction in reported number of cigarettes per day. Patients were ask to report the average number of cigarettes smoked per day on the 6mo and baseline surveys. if Xb is the average number smoked at baseline and X6 is the average number smoked at 6 months Then the reduction was calculated as (Xb-X6)/Xb
Significant Reduction in Smoking @ 3 Months	baseline and 3 months	Significant reduction in daily smoking from baseline to 6 months was defined as \> 50% reduction in reported number of cigarettes per day. Patients were ask to report the average number of cigarettes smoked per day on the 3mo and baseline surveys. if Xb is the average number smoked at baseline and X3 is the average number smoked at 3 months Then the reduction was calculated as (Xb-X3)/Xb

Trial Locations

Locations (42): Alaska Women's Cancer Care
🇺🇸
Anchorage, Alaska, United States
Unity Hospital
🇺🇸
Fridley, Minnesota, United States
Katmai Oncology Group
🇺🇸
Anchorage, Alaska, United States
HSHS Saint Nicholas Hospital
🇺🇸
Sheboygan, Wisconsin, United States
Aurora BayCare Medical Center
🇺🇸
Green Bay, Wisconsin, United States
Northside Hospital
🇺🇸
Atlanta, Georgia, United States
Good Samaritan Regional Health Center
🇺🇸
Mount Vernon, Illinois, United States
Freeman Health System
🇺🇸
Joplin, Missouri, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
🇺🇸
Oconto Falls, Wisconsin, United States
Augusta University Medical Center
🇺🇸
Augusta, Georgia, United States
Carle Cancer Center
🇺🇸
Urbana, Illinois, United States
Carle on Vermilion
🇺🇸
Danville, Illinois, United States
Physicians' Clinic of Iowa PC
🇺🇸
Cedar Rapids, Iowa, United States
Heartland Regional Medical Center
🇺🇸
Saint Joseph, Missouri, United States
Baptist Memorial Hospital and Cancer Center-Desoto
🇺🇸
Southhaven, Mississippi, United States
CoxHealth South Hospital
🇺🇸
Springfield, Missouri, United States
CaroMont Regional Medical Center
🇺🇸
Gastonia, North Carolina, United States
Margaret R Pardee Memorial Hospital
🇺🇸
Hendersonville, North Carolina, United States
OhioHealth Marion General Hospital
🇺🇸
Marion, Ohio, United States
Marietta Memorial Hospital
🇺🇸
Marietta, Ohio, United States
Strecker Cancer Center-Belpre
🇺🇸
Belpre, Ohio, United States
Southern Ohio Medical Center
🇺🇸
Portsmouth, Ohio, United States
Prisma Health Cancer Institute - Easley
🇺🇸
Easley, South Carolina, United States
Prisma Health Cancer Institute - Eastside
🇺🇸
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
🇺🇸
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Seneca
🇺🇸
Seneca, South Carolina, United States
Baptist Memorial Hospital and Cancer Center-Memphis
🇺🇸
Memphis, Tennessee, United States
Prisma Health Cancer Institute - Spartanburg
🇺🇸
Spartanburg, South Carolina, United States
MultiCare Good Samaritan Hospital
🇺🇸
Puyallup, Washington, United States
MultiCare Auburn Medical Center
🇺🇸
Auburn, Washington, United States
MultiCare Tacoma General Hospital
🇺🇸
Tacoma, Washington, United States
MultiCare Gig Harbor Medical Park
🇺🇸
Gig Harbor, Washington, United States
Baptist Memorial Hospital for Women
🇺🇸
Memphis, Tennessee, United States
ThedaCare Regional Cancer Center
🇺🇸
Appleton, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
🇺🇸
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
🇺🇸
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
🇺🇸
Sturgeon Bay, Wisconsin, United States
Prisma Health Cancer Institute - Butternut
🇺🇸
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
🇺🇸
Greer, South Carolina, United States
Iowa Methodist Medical Center
🇺🇸
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
🇺🇸
Des Moines, Iowa, United States
Montefiore Medical Center - Moses Campus
🇺🇸
Bronx, New York, United States