Tobacco Use Treatment in Cancer Patients

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

At UF Health Cancer Center (UFHCC), patient access and utilization of tobacco use treatment are sub optimal.

It had three arms (groups): Cognitive Behavior Therapy with NRT (other), Referral to Area Health Education Center (other) and Referral to Qutiline (other).

Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.

The registry classes the interventions as drug and other.

More on the Plan

Study Setting: The pilot study will be conducted at the UF Health Medical Oncology and Ear, Nose \& Throat (ENT) clinics.

Smoking is the leading cause of head and neck cancers, and almost one-third of patients continue to smoke after their head and neck cancer diagnosis, making this a priority population for intervention.

Population: UF Health cancer patients ≥18 yrs old who are current smokers and smartphone users; for mCBT, the investigators will also ensure CO breath sample \>5 parts per million (ppm).

Patients with unstable medical or psychiatric illness or use disorder for illicit drugs will be excluded.

Who Took Part

Enrollment: 90 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: UF Health cancer patients, 18 years and older, who are current smokers.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: patients with unstable medical or psychiatric illness or; patients with a use disorder for illicit drugs.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-05-14 with completion listed for 2019-12-31.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Smoking 7-Day Point Prevalence at 12 Weeks (time frame: 12 weeks). Reach (time frame: 12 weeks). Treatment Utilization (time frame: 12 weeks).

It also tracked 1 secondary outcome, for example Change in Cigarettes Smoked Per Day.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Therapeutic nicotine (patch, non-peptide) in 90 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.