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Smoke-Free Homes Intervention for the Prevention of Smoking

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Prevention
NCT ID
NCT04547686
Protocol IDs
SFH-5A-RCT (primary)
NCI-2021-01784
STUDY00001085
Study Sponsor
Emory University Hospital/Winship Cancer Institute

Summary

This clinical trial studies the effect of a smoke-free homes intervention in preventing smoking. This study aims to see whether smoke-free home rules support smokers in changing their smoking behaviors.

Objectives

PRIMARY OBJECTIVES:
I. Partner with seven large Federally Qualified Health Center (FQHC)s in Georgia to conduct a randomized controlled trial to test the efficacy of integrating a robust smoke free home (SFH)s intervention into the 5A approach for tobacco cessation among FQHC patients.
II. Conduct a process evaluation of the expanded intervention to assess implementation outcomes, cost, and scalability potential.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive adapted smoke-free homes intervention including three interactive mailings at baseline, 4, and 6 weeks, and two coaching calls over 20-30 minutes each at 2 and 10 weeks. Participants are guided through 3 modules to make each space smoke-free. Participants who report quitting at the 6- and 12-month follow-up undergo collection of saliva and urine samples. Participants also receive mailed information on the quitline.

ARM II: Participants receive mailed information on the quitline. Participants who report quitting at the 6- and 12-month follow-up undergo collection of saliva and urine samples.

After completion of study, participants are followed up at 6 and 12 months.

Eligibility

  1. Patients, 18 years of age and older that are referred by their primary care physician or provider of a participating FQHC in South Georgia
  2. Having smoked at least one cigarette in the past 30 days
  3. Ability to speak and understand English
  4. Be the only patient per household to be enrolled in the study
  5. Not currently be enrolled in a cessation program
  6. INCLUSION CRITERIA FOR THE PROCESS EVALUATION INTERVIEWS: Participant will be FQHC leaders, directors, and medical providers
  7. INCLUSION CRITERIA FOR THE PROCESS EVALUATION INTERVIEWS: 18 years of age and older
**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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.