Malignant Neoplasm Clinical Trial
Official title:
Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"
Verified date | January 2024 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
ECOG-ACRIN Cancer Research Group | National Cancer Institute (NCI) |
United States,
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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