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

Malignant Neoplasm Clinical Trial

Official title:

Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808818
• Other study ID #: EAQ171CD
• Secondary ID: NCI-2018-02826EA
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma In Situ
• Current Smoker
• Malignant Neoplasm
• Neoplasms
• Primary Neoplasm
• Recurrence
• Recurrent Neoplasm

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