NCT05008848

Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program

Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Smoking Cessation Intervention	Participate in schedule gradual reduction program
OTHER	Health Promotion and Education	Receive cessation support messages
OTHER	Informational Intervention	Receive NCI's Clearing the Air booklet
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-04-01
• Primary completion: 2027-03-01
• Completion: 2027-08-01
• First posted: 2021-08-17
• Last updated: 2026-04-07

Locations

215 sites across 1 country: United States