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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03808818
Other study ID # EAQ171CD
Secondary ID NCI-2018-02826EA
Status Completed
Phase Phase 2
First received
Last updated
Start date August 1, 2019
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 415
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Behavioral, Psychological or Informational Intervention
Receive information about tobacco cessation
Drug:
Nicotine Replacement
Given NRT patch or lozenge (or both)
Other:
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Tobacco Cessation Counseling
Receive virtual tobacco cessation counseling

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Potential effect of sociodemographics on treatment effectiveness Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments. Up to 6 months
Other Potential effect of medical and smoking history on treatment effectiveness Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments. Up to 6 months
Other Potential effect of cancer variables on treatment effectiveness Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments. Up to 6 months
Other Implementation of the intervention at community oncology sites Will follow Proctor and colleagues' recommended taxonomy for measurement of implementation outcomes. Will measure acceptability (satisfaction with content/delivery), adoption (program uptake), appropriateness (relevance), cost, and treatment fidelity/adaptation and penetration (reach) and sustainability. These implementation outcomes will be assessed with mixed methods using qualitative and quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcomes (acceptability, adoption, appropriateness, fidelity, cost, penetration and sustainability) and conduct treatment group comparisons (i.e., acceptability). Up to 36 months
Other Intervention acceptability (satisfaction with content/delivery) at community oncology sites Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. Up to 36 months
Other Intervention adoption (program uptake) at community oncology sites Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. Up to 36 months
Other Intervention appropriateness (relevance) at community oncology sites Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. Up to 36 months
Other Intervention cost at community oncology sites Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. Up to 36 months
Other Treatment fidelity/adaptation at community oncology sites Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. Up to 36 months
Other Intervention penetration (reach) at community oncology sites Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. Up to 36 months
Other Intervention sustainability at community oncology sites Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons. Up to 36 months
Primary 7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO) 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 nicotine replacement (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. Chi-square tests will be used to compare the outcomes between treatment groups. At 6 months
Secondary Biochemically-confirmed 7-day point prevalence abstinence by saliva cotinine or expired air CO 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. Chi-square tests will be used to compare the outcomes between treatment groups. At 3 months
Secondary Self-reported 7-day point prevalence abstinence Chi-square tests will be used to compare the outcomes between treatment groups. At 3 months
Secondary Self-reported 7-day point prevalence abstinence Chi-square tests will be used to compare the outcomes between treatment groups. At 6 months
Secondary Self-reported continuous tobacco abstinence Chi-square tests will be used to compare the outcomes between treatment groups. At 6 months
Secondary Sustained tobacco abstinence 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. At 6 months
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