Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smoking Cessation Intervention, Health Promotion and Education, Informational Intervention, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Cigarette Smoking-Related Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Cessation Interventions
Overview
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.
Interventions
- 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
Primary outcome measures
- Biochemically validated tobacco cessation [Time frame: Up to 6 months post-quit date]
Secondary outcome measures (1)
- Serially measured overall quality of life (QoL) scores obtained at baseline and at 30-days and 6-months post-quite date [Time frame: Up to 6-months post-quit date]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 223 centers
- Kingman Regional Medical Center — Kingman
- Mercy Hospital Fort Smith — Fort Smith
- Saint Helena Hospital — St. Helena
- Banner North Colorado Medical Center — Greeley
- Banner North Colorado Medical Center - Loveland Campus — Loveland
- Malcom Randall Veterans Administration Medical Center — Gainesville
- Northeast Georgia Medical Center Braselton — Braselton
- Northeast Georgia Medical Center-Gainesville — Gainesville
- … and 215 more centers
Identifiers
NCT: NCT05008848 · A211901 · NCI-2021-03543 · UG1CA189823