Reaching Rural Cancer Survivors Who Smoke

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT05008848
Trial Phases:	Phase III	Protocol IDs:	A211901 (primary) A211901 A211901 NCI-2021-03543
Eligibility:	18 Years and older, Male and Female	Study Type:	Prevention
Study Sponsor:	Alliance for Clinical Trials in Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT05008848

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.

**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... Click here to learn more about clinical trials.