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Smoking Cessation Interventions for Pregnant Women

N/A
Recruiting
Led By Jan Blalock
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Study Summary

This trial seeks to help low-income pregnant women quit smoking. Smoking during pregnancy is associated with an increased risk of low birth weight, which can lead to health problems for the baby.

Who is the study for?
This trial is for low-income pregnant women in Northeast Texas who smoke or allow smoking at home. It's also open to household members who smoke. Participants must be receiving services from WIC or FQHC clinics, consent to surveys, and speak English or Spanish.Check my eligibility
What is being tested?
The study tests a program designed to help pregnant women quit smoking through counseling, telephone support, educational materials, and surveys. The goal is to reduce cancer risks associated with smoking and improve birth outcomes.See study design
What are the potential side effects?
There are no direct medical side effects from participating as the interventions involve counseling and information provision rather than medication. However, quitting smoking can lead to withdrawal symptoms like irritability and cravings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To provide proactive referral to services to participants

Side effects data

From 2019 Phase 2 trial • 107 Patients • NCT00983580
4%
Tinnitus
2%
Rectal pain
2%
Pain
2%
Hearing test abnormal
2%
Rectal hemorrhage
2%
Dizziness
2%
Gastrointestinal disorder
2%
Headache
2%
Musculoskeletal disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Acetylsalicylic Acid and Eflornithine)
Arm II (Placebo)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Goal 4 (counseling)Experimental Treatment4 Interventions
Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.
Group II: Goal 3 (Smoke-free Homes)Experimental Treatment5 Interventions
Participants receive the Smoke-Free Homes kit providing guidance for how to talk with household members and visitors about not smoking inside the home. Participants may also receive 3 separate Smoke-Free Homes mailings over 6 weeks, and a coaching call from a Baby Steps for Health counselor to help follow the steps described in the mailed materials in order to set up a smoke-free home.
Group III: Goal 2 (counseling, Wellness app, self-help)Experimental Treatment6 Interventions
Participants receive telephone counseling sessions over 30-45 minutes for a minimum of 6 sessions in the prenatal period and about 4-6 postpartum period. Participants who start counseling after birth, may receive 6-8 sessions up to 4 months postpartum. Participants may also use the Pregnancy and Wellness smartphone app that provides wellness messages, smoking cessation information, relapse prevention tips, and tips to create a smoke-free home. Participants also receive tobacco cessation self-help materials including National Partnership for Smoke Free Families and Forever Free Baby and Me.
Group IV: Goal 1 (Wellness app)Experimental Treatment4 Interventions
Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smoking Cessation Intervention
2005
N/A
~1800
Telephone-Based Intervention
2017
Completed Phase 2
~3360

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,945 Previous Clinical Trials
1,749,223 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,585 Previous Clinical Trials
41,187,287 Total Patients Enrolled
Jan BlalockPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
99 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies in this medical trial?

"Confirmed. The clinical trial is currently enrolling participants, with the initial post on February 18th 2020 and most recent update occurring September 28th 2022 per information obtainable via ClinicalTrials.gov"

Answered by AI

How many individuals have taken part in this experiment?

"Affirmative. According to the information accessible through clinicaltrials.gov, this research is currently searching for 54158 participants at a single site; its initial posting was on February 18th 2020 and it has most recently been updated on September 28th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
~22838 spots leftby Feb 2027