Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients

What Was Tested

In this early phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Arm I - Quitline (experimental) and Arm II - Usual Care (no intervention).

The registry classes the interventions as drug.

More on the Plan

Following the intervention, the researchers will assess participant, CRA (Clinical Research Associate) Counselor and Quitline staff ratings of acceptability, resources required to deliver the intervention, protocol fidelity, and participant recruitment, retention and adherence.

Secondary * To obtain a preliminary estimate of the quit rate (as defined by 7-day point-prevalence abstinence) in intervention and control groups.

To accomplish this aim, following the intervention the researchers will collect confirmed smoking status data for intervention and control subjects.

OUTLINE: This is a multicenter study.

Who Took Part

146 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Reports smoking any amount in the last 7 days. 18 years of age or older. KPS of 70-100. Ability to understand and the willingness to sign a written informed consent document. Willing to consider quitting smoking.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: unstable cardiac disease - defined as congestive heart failure, unstable angina, serious arrhythmias, or myocardial infarction in the past month; use of illegal drugs or use of prescription medications for non-medical reasons in the past month; current use of chewing, dipping and pipe tobacco, or cigars.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2011-10-01 with completion listed for 2014-06-01.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Adherence (time frame: 24 weeks).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 146 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.