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

Cancer Clinical Trial

— MAW Phase 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018640
• Other study ID #: 11-001144 Phase 2
• Secondary ID: U54CA153605
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: December 15, 2017
• Start date: December 2013
• Est. completion date: August 2015

Study information

• Verified date: December 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Developing effective tobacco cessation interventions during pregnancy for American Indian and Alaska Native people is a national priority and will contribute to the U.S. public health objective of reducing tobacco-related cancer health disparities. The proposed project builds on our successful partnership with the Alaska Native community and previous work with Alaska Native pregnant women. We propose to develop and test a novel biomarker feedback intervention relating cotinine levels in the urine of pregnant women with the woman and infant's likely exposure to the tobacco specific nitrosamine and carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK). This 5-year project will be conducted in three phases. In Phase 1 we utilized a non-randomized, clinical observational trial to examine biomarkers of nicotine and carcinogen exposure (urine cotinine and total NNAL [a metabolite of NNK], respectively) among maternal-infant pairs with assessments conducted during pregnancy and at delivery. In Phase 2, we will obtain qualitative feedback on the findings from Phase 1 through individual interviews conducted with women who use tobacco and a confidant (partner/friend/relative) they have identified to develop the biomarker feedback intervention messages. Phase 3 will consist of a formative evaluation of the biomarker feedback intervention with pregnant women using a two-group randomized design to assess the intervention's feasibility and acceptability, and the biochemically confirmed abstinence rate at the end of pregnancy. All phases of the project will be guided by a Community Advisory Committee. Each phase is an important step to advance our understanding of the potential for biomarker feedback as a strategy to help Alaska Native pregnant women quit tobacco use. The potential reach of the intervention is significant from a public health perspective as over 600 tobacco users deliver each year at the Alaska Native Medical Center in Anchorage where the proposed project will take place. Developing effective interventions for tobacco cessation during pregnancy is important to reduce adverse health consequences for the mother and neonate and future risk of tobacco-caused cancers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

To be eligible the woman must:

1. be Alaska Native

2. be aged 18 years of age or older

3. provide written informed consent

4. have participated in Phase 1 of the research or is currently pregnant (<= 24 weeks gestation)

5. 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:

1. be referred by the woman participant

2. be aged 18 years of age or older

3. provide written informed consent

Exclusion Criteria:

1. does not provide written informed consent

Related Conditions & MeSH terms

• Cancer
• Pregnancy
• Tobacco Use

Locations

Country	Name	City	State
United States	Alaska Native Tribal Health Consortium	Anchorage	Alaska

Sponsors (5)

Lead Sponsor	Collaborator
Mayo Clinic	Alaska Native Tribal Health Consortium, National Cancer Institute (NCI), University of California, San Francisco, University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	receptivity to cancer risk messages	interview of participant reactions to biomarker findings	baseline
Secondary	confidant perceptions of cancer risk information	interview of family members, friends, relatives	baseline