Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2

NCT02018640 | Completed DMC

• 2 other identifiers: 11-001144 Phase 2U54CA153605
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Use of tobacco is very high among Alaska Native pregnant women. The investigators are conducting a three phase study. The first study is nearly completed and involved measuring biomarkers of tobacco exposure in mothers and infants. The second phase of the research is a qualitative study to translate the biomarker findings to an intervention.

Conditions

Cancer; Tobacco Use; Pregnancy

Keywords

cancer; tobacco use; pregnancy

Outcome Measures

Primary Outcomes (1)

• receptivity to cancer risk messages

  interview of participant reactions to biomarker findings

  baseline

Secondary Outcomes (1)

• confidant perceptions of cancer risk information

  baseline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Alaska Native women and their confidants

You may qualify if:

• To be eligible the woman must:
• be Alaska Native
• be aged 18 years of age or older
• provide written informed consent
• have participated in Phase 1 of the research or is currently pregnant (\<= 24 weeks gestation)
• have used any tobacco product at least once in the past 7 days (cigarettes or both cigarettes/ST)
• To be eligible the confidant (he/she) must:
• be referred by the woman participant
• be aged 18 years of age or older
• provide written informed consent

You may not qualify if:

• \. does not provide written informed consent

Sponsors & Collaborators

• Mayo Clinic: lead
• Alaska Native Tribal Health Consortium: collaborator
• University of California, San Francisco: collaborator
• University of Minnesota: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99577, United States

Location

MeSH Terms

Conditions

Neoplasms; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

US (1)