Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cigarette Smoking-Related Carcinoma

Intervention / Treatment
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* Behavioral: Smoking Cessation Intervention
* Other: Health Promotion and Education
* Other: Informational Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (SGR program, text messages)<br>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. | Behavioral: Smoking Cessation Intervention<br>* Participate in schedule gradual reduction program<br>Other: Health Promotion and Education<br>* Receive cessation support messages<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (booklet)<br>Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking. | Other: Informational Intervention<br>* Receive NCI's Clearing the Air booklet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically validated tobacco cessation | Response will be defined as (1) urine cotinine levels < 50 ng/ml or (2) urine cotinine levels >=50 ng/ml and an urine anabasine level < 2 ng/ml if a patient self-reports vaping use or the use of nicotine replacement therapy (NRT). Patients who do not return at 6 months post-quit date for the cotinine assessment (and anabasine, if applicable) will be deemed non-responders. The analysis population is defined as all randomized and eligible patients. The primary evaluation of the primary outcome will be the covariate-adjusted intervention effect (adjusted odds ratio) obtained from a multiple logistic regression model adjusted for the three stratification factors baseline daily cigarette consumption, age, and sex as well as the potential confounding variables cancer diagnosis, cancer type, receipt of chemotherapy, receipt of radiation therapy, and active treatment. | Up to 6 months post-quit date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serially measured overall quality of life (QoL) scores obtained at baseline and at 30-days and 6-months post-quite date | At a given measurement time point, the patient-reported overall QoL score will be obtained from a linear analogue self-assessment scale (LASA), which is an 11-point scoring scale (0, 1, …, 10) where 0 indicates as bad as can be and 10 indicates as good as can be. A linear mixed model will be used to compare the average difference between the randomized arms across the two post-randomization time points after adjusting for the baseline overall QoL score, the three stratification factors baseline daily cigarette consumption, age, and sex as well as the potential confounding variables cancer diagnosis, cancer type, receipt of chemotherapy, receipt of radiation therapy, and active treatment. | Up to 6-months post-quit date |