Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Purpose
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.
Condition
- Cigarette Smoking-Related Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group I (SGR program, text messages) |
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. |
|
|
Active Comparator Group II (booklet) |
Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking. |
|
Recruiting Locations
Olathe, Kansas 66061
Topeka, Kansas 66606
Site Public Contact
785-295-8000
More Details
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
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.