CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 146 enrolled
Drug / intervention
Nicotine Replacement Patchdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01434342
NCT01434342Early Ph 1Completed

Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Lung Cancer Patients Receiving Outpatient Treatment: A Pilot Study

Wake Forest University Health Sciences·interventional·Posted Sep 14, 2011·Updated Sep 28, 2021

In Brief

A Early Phase 1 clinical trial evaluating Nicotine Replacement Patch for Lung Cancer and 4 related conditions. Completed, enrolled 146 participants across 1 site.

Detailed Summary

RATIONALE: Continued smoking after a cancer diagnosis has important health consequences beyond the risks associated with smoking in the general population. Smoking reduces the efficacy of cancer treatments including surgery, radiation and chemotherapy. Despite the negative consequences, it is estimated that between 15-75% of patients with cancer continue to smoke after their cancer diagnosis. Lung, breast, prostate, colorectal, bladder, head \& neck, and cervical cancer patients were chosen because there is evidence of potential clinical benefit associated with quitting smoking in all of these populations and they represent a mix of both smoking and non-smoking related cancers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2011
Enrollment StartOct 1, 2011
Primary CompletionJun 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.8 years ago

Interventions

Nicotine Replacement Patchdrug

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 weeks after the date of the in-person intervention (for Quitline Intervention group) or the provision of the physician letter (for the Usual Care Plus group).