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Behavioral Intervention

Text-Based Smoking Cessation Program for Rural Cancer Survivors

Phase 3

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

In order to complete the mandatory patient-completed measures, participants must be able to speak and read English

Must not have

Patients with impaired decision-making capacity are not eligible for this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6-months post-quit date

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a text-based quitting program can help rural cancer patients who smoke, quit smoking. The program gradually reduces the amount of cigarettes smoked, with the goal of quitting altogether.

Who is the study for?

This trial is for rural cancer survivors who currently smoke at least 5 cigarettes daily, have had a cancer diagnosis within the last decade, and may still be undergoing treatment. Participants must be adults with texting-capable phones, not using smoking cessation drugs or programs, able to read English, and willing to provide a urine sample.

What is being tested?

The study compares a text-based program designed to help smokers quit by gradually reducing cigarette use against traditional methods like manuals. The goal is to see if scheduled texts can more effectively lead participants to stop smoking entirely.

What are the potential side effects?

Since this trial involves educational and informational interventions rather than medications, there are no direct medical side effects. However, participants might experience typical nicotine withdrawal symptoms such as irritability, cravings, or difficulty concentrating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can speak and read English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am capable of making my own health decisions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post-quit date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post-quit date

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post-quit date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biochemically validated tobacco cessation

Secondary study objectives

Serially measured overall quality of life (QoL) scores obtained at baseline and at 30-days and 6-months post-quite date

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (SGR program, text messages)Experimental Treatment3 Interventions

Patients participate in schedule gradual reduction program over 8 weeks to reduce the frequency of cigarette use. Patients also receive cessation support messages via text messages for 12 weeks.

Group II: Group II (booklet)Active Control1 Intervention

Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Smoking Cessation Intervention

2005

N/A

~1800

0 / 3Eligibility criteria met