Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program

Alliance for Clinical Trials in Oncology

Status and phase: Enrolling; Phase 3

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Other: Questionnaire Administration; Other: Health Promotion and Education; Other: Informational Intervention; Behavioral: Smoking Cessation Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05008848

A211901

UG1CA189823 (U.S. NIH Grant/Contract)

NCI-2021-03543 (Registry Identifier)

Details and patient eligibility

About

This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

Full description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of an eight-week text-based scheduled gradual reduction (SGR) intervention (a personalized eight-week reduction schedule paired with National Cancer Institute's [NCI's] Smokefree.TXT) compared to a control intervention (NCI Clearing the Air Cessation Booklet) on biochemically-validated smoking cessation six-month post-quit date in rural cancer survivors.

SECONDARY OBJECTIVE:

I. Compare the efficacy of the eight-week text-based SGR intervention and a control intervention on Linear Analog Self-Assessment (LASA)-6 overall quality of life (QOL) at 30-days post-quit date and six-months post-quit date.

OUTLINE: Patients are randomized to 1 of 2 groups.

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

After completion of study, patients are followed up at 6 months.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a cancer diagnosis within the past 10 years, and can currently be receiving curative treatment
• Not currently on hospice
• Currently smokes >= 5 cigarettes daily
• Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code [RUCC] code of 4-9)
• Patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial
• Not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program
• Patient has a cell phone or smart phone device with texting ability
• In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
• Age >= 18 years
• Participant must be willing to provide a urine sample.

Exclusion criteria

• Psychiatric illness which would prevent the patient from giving informed consent
• Patients with impaired decision-making capacity are not eligible for this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Group I (SGR program, text messages)

Experimental group

Description:

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.

Treatment:

Behavioral: Smoking Cessation Intervention

Other: Health Promotion and Education

Other: Questionnaire Administration

Group II (booklet)

Active Comparator group

Description:

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

Treatment:

Other: Informational Intervention