NCT02596711

Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers

Completed Phase 1, PHASE2 Results posted Last updated 10 March 2020

What this trial tests

Phase 1, PHASE2 trial testing Nicotine Patch in Tobacco Use Cessation in 26 participants. Completed in 22 August 2017.

Timeline

2 November 2015

Primary endpoint
22 August 2017

22 August 2017

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	2 November 2015
Primary completion	22 August 2017
Estimated completion	22 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Nicotine Patch (nicotine-patch) — full drug profile →
• Questionnaires
• Carbon Monoxide (CO) Test
• Health Education and Handouts
• Culturally Tailored Reading Materials
• Counseling Sessions

Conditions studied

• Tobacco Use Cessation — all drugs for Tobacco Use Cessation →
• Cancer Prevention — all drugs for Cancer Prevention →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Tobacco Use Cessation or Cancer Prevention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intervention Feasibility & Acceptability Primary · Averaged across 3 study visits (Week 0 to Week 12)

The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating g

Group	Value	95% CI
Health Education (HE)	4.87	± 0.35
Culturally-Tailored (CT)	4.71	± 0.48
Culturally-Tailored With Adherence Enhancement (CT+AE)	4.83	± 0.4

Patch Adherence: Percentage of Days With Patch Primary · This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.

Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.

Group	Value	95% CI
Health Education (HE)	64.6	± 17.7
Culturally-Tailored (CT)	68.6	± 13.66
Culturally-Tailored With Adherence Enhancement (CT+AE)	81.3	± 3.32

Number of Abstinent Participants Primary · Collected at the 3- and 6-month follow-up visits

Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.

3-month follow-up

Group	Value	95% CI
Health Education (HE)	4
Culturally-Tailored (CT)	2
Culturally-Tailored With Adherence Enhancement (CT+AE)	4

6-month follow-up

Group	Value	95% CI
Health Education (HE)	4
Culturally-Tailored (CT)	2
Culturally-Tailored With Adherence Enhancement (CT+AE)	3

Adverse events — posted to ClinicalTrials.gov

Time frame: End of treatment and 6 month follow-up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Health Education (HE)

Serious: 0/9 (0%)

Deaths: 0/9

Culturally-Tailored (CT)

Serious: 0/8 (0%)

Deaths: 0/8

Culturally-Tailored With Adherence Enhancement (CT+AE)

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (5 terms — click to expand)

Reaction	System	Health Education (HE)	Culturally-Tailored (CT)	Culturally-Tailored With A…
Nausea and changes in appetite, likely related to increase in patch dosage	Gastrointestinal disorders	—	—	—
Rapid heart rate and anxiety, likely related to patch use	General disorders	—	—	—
Sleep disturbances, anxiety, abnormal taste in mouth, trouble concentrating, sad mood.	Psychiatric disorders	—	—	—
Mild sleep disturbance and irratbility.	Psychiatric disorders	—	—	—
Sleep disturbance, constipation, skin irritation and lesion at patch site, lower back pain, phlegm i	General disorders	—	—	—

Data from ClinicalTrials.gov NCT02596711 adverse events section.

Sponsor's own description

The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A pilot randomized trial examining the feasibility and acceptability of a culturally tailored and adherence-enhancing intervention for Latino smokers in the U.S.
   de Dios MA, Cano MÁ, Vaughan EL, Childress SD, et al · · 2019 · cited 14× · PMID 30633744 · DOI 10.1371/journal.pone.0210323