Comparison · NCT03808818-sae
Virtual Counseling (Virtual Counseling Sessions, NRT) vs Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Virtual Counseling (Virtual Counseling Sessions, NRT) vs Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral): serious adverse events. Trial comparisons, record NCT03808818-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03808818-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0641 | 0.0352 | 0.114 | wilson | |
| Risk in group 2 | 0.0867 | 0.0513 | 0.143 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0226 | -0.0856 | 0.0385 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.74 | 0.335 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 0.722 | 0.306 | 1.7 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Virtual Counseling (Virtual Counseling Sessions, NRT) than on Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) | 44.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Virtual Counseling (Virtual Counseling Sessions, NRT) | 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).~Nicotine Replacement: Given NRT patch or lozenge (or both)~Quality-of-Life Assessment: Ancillary studies~Survey Administration: Ancillary studies~Tobacco Cessation Counseling: Receive virtual tobacco cessation counseling | 10 | 156 | EG001 |
| Group 2 | Enhanced Usual Care (Smoking Assessment, Quitting Advice, Quitline Referral) | 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.~Behavioral, Psychological or Informational Intervention: Receive information about tobacco cessation~Quality-of-Life Assessment: Ancillary studies | 13 | 150 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- from randomization up to 1 year
Source ClinicalTrials.gov
Trial
- Title
- Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
- NCT number
- NCT03808818
- Phases
- NA
- Conditions
- Carcinoma In Situ, Current Smoker, Malignant Neoplasm, Primary Neoplasm, Recurrent Neoplasm, Smoking Cessation
- Interventions
- Behavioral, Psychological or Informational Intervention, Nicotine Replacement, Quality-of-Life Assessment, Survey Administration, Tobacco Cessation Counseling
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Results first posted
- 2025-03-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03808818?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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