Comparison · NCT01434342-sae
Arm I - Quitline vs Arm II - Usual Care: 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. Arm I - Quitline vs Arm II - Usual Care: serious adverse events. Trial comparisons, record NCT01434342-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01434342-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 | 0.187 | 0.115 | 0.289 | wilson | |
| Risk in group 2 | 0.135 | 0.0591 | 0.28 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0515 | -0.11 | 0.179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.38 | 0.538 | 3.54 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 0.485 | 4.44 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I - Quitline than on Arm II - Usual Care | 19.4 | 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 | Arm I - Quitline | Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 we | 14 | 75 | EG000 |
| Group 2 | Arm II - Usual Care | Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's Clearing the Air smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy. | 5 | 37 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 24 weeks
Source ClinicalTrials.gov
Trial
- Title
- Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients
- NCT number
- NCT01434342
- Phases
- EARLY_PHASE1
- Conditions
- Lung Cancer, Tobacco Use Disorder, Breast Cancer, Colorectal Cancer, Prostate Cancer
- Interventions
- Nicotine Replacement Patch
- Lead sponsor
- Wake Forest University Health Sciences
- Results first posted
- 2017-06-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01434342?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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