Reaching Rural Cancer Survivors Who Smoke
18 Years and older, Male and Female
A211901 (primary)
A211901
A211901
NCI-2021-03543
Summary
This phase III trial compares the effect of text-based cessation intervention to manuals in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarettes use to zero and may be effective in quitting smoking.
Objectives
PRIMARY OBJECTIVE:
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 Global quality of life (QOL) at 30-days post-quit date and six-months post-quit date.
EXPLORATORY OBJECTIVES:
I. Compare changes in the 5 LASA scales between the SGR group and the control group.
II. Compare changes in the total score obtained from the Fagerstrom Test for Nicotine Dependence (FTND) between the SGR group and the control group.
III. Describe intervention adherence (response to SGR texts) and intervention interaction (number of times participants text the system for support) for patients randomized to the intervention group.
IV. Explore the predictive role of degree of urbanization (e.g. Rural Urban Continuum Code [RUCC] 4-9) on smoking cessation.
V. Explore the effects of the SGR intervention and control intervention on other health behaviors (sleep, alcohol use, physical activity and fruit and vegetable intake).
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.
Eligibility
- Have a cancer diagnosis within the past 10 years
* Note: Patients with ductal carcinoma in situ (DCIS) are eligible and patients currently receiving curative treatment are eligible
- Not currently on hospice
- Currently smokes >= 5 cigarettes daily
* Note: Participants who vape are eligible
- Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code [RUCC] code of 4-9) and/or a Rural-Urban Commuting area code of 4-10
- 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 for smoking purposes only), or currently participating in any cessation program at the time of enrollment
- Patient has a cell phone or smart phone device with texting ability
- Language: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish
- Age >= 18 years
- Participant must be willing to provide a urine sample
- Patients with impaired decision-making capacity are not eligible for this study
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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