N/A
Completed N=306
Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
Carcinoma In Situ · Current Smoker · Malignant Neoplasm · Primary Neoplasm
Source: ClinicalTrials.gov NCT03808818 ↗
Enrolled (actual)
306
Serious AEs
7.5%
Results posted
Mar 2025
Primary outcomePrimary: Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemically-confirmed 7-day Point Prevalence Abstinence at 6 Months (Not Evaluated) |
— | — |
| SECONDARY Biochemically-confirmed 7-day Point Prevalence Abstinence at 3 Months (Not Evaluated) |
— | — |
| SECONDARY 7-day Point-prevalence Tobacco Abstinence at 6 Months - Self Report |
21; 42 | 0.0046 sig |
| SECONDARY 7-day Point-prevalence Tobacco Abstinence at 3 Months - Self Report |
22; 38 | 0.035 sig |
| SECONDARY Self-reported Continuous Tobacco Abstinence |
13; 28 | 0.016 sig |
| SECONDARY Sustained Tobacco Abstinence at 6 Months (Not Evaluated) |
— | — |
| SECONDARY Significant Reduction in Smoking |
47; 64 | 0.069 |
| SECONDARY Significant Reduction in Smoking @ 3 Months |
53; 57 | 0.86 |
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.
Data sourced from ClinicalTrials.gov (NCT03808818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.