Telephone-Based Intervention for Cigarette Smoking-Related Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cigarette Smoking-Related Carcinoma
Telephone-Based Intervention - Behavioral
Eligibility
18+
Female
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Through study completion, an average of 1 year

Year 1
To provide proactive referral to services to participants

Trial Safety

Side Effects for

Arm I (Acetylsalicylic Acid and Eflornithine)
4%Tinnitus
2%Rectal hemorrhage
2%Rectal pain
2%Pain
2%Hearing test abnormal
2%Dizziness
2%Gastrointestinal disorder
2%Headache
2%Musculoskeletal disorder
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT00983580) in the Arm I (Acetylsalicylic Acid and Eflornithine) ARM group. Side effects include: Tinnitus with 4%, Rectal hemorrhage with 2%, Rectal pain with 2%, Pain with 2%, Hearing test abnormal with 2%.

Trial Design

4 Treatment Groups

Goal 1 (Wellness app)
1 of 4
Goal 2 (counseling, Wellness app, self-help)
1 of 4
Goal 4 (counseling)
1 of 4
Goal 3 (Smoke-free Homes)
1 of 4
Experimental Treatment

54158 Total Participants · 4 Treatment Groups

Primary Treatment: Telephone-Based Intervention · No Placebo Group · N/A

Goal 1 (Wellness app)Experimental Group · 4 Interventions: Questionnaire Administration, Informational Intervention, Survey Administration, Media Intervention · Intervention Types: Other, Other, Other, Other
Goal 2 (counseling, Wellness app, self-help)Experimental Group · 6 Interventions: Tobacco Cessation Counseling, Questionnaire Administration, Informational Intervention, Survey Administration, Telephone-Based Intervention, Media Intervention · Intervention Types: Other, Other, Other, Other, Behavioral, Other
Goal 4 (counseling)Experimental Group · 4 Interventions: Tobacco Cessation Counseling, Questionnaire Administration, Survey Administration, Telephone-Based Intervention · Intervention Types: Other, Other, Other, Behavioral
Goal 3 (Smoke-free Homes)Experimental Group · 5 Interventions: Smoking Cessation Intervention, Questionnaire Administration, Informational Intervention, Survey Administration, Telephone-Based Intervention · Intervention Types: Behavioral, Other, Other, Other, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smoking Cessation Intervention
2005
N/A
~1630
Telephone-Based Intervention
2018
Completed Phase 2
~3250

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,730,861 Total Patients Enrolled
4 Trials studying Cigarette Smoking-Related Carcinoma
2,634 Patients Enrolled for Cigarette Smoking-Related Carcinoma
National Cancer Institute (NCI)NIH
12,989 Previous Clinical Trials
41,244,900 Total Patients Enrolled
9 Trials studying Cigarette Smoking-Related Carcinoma
5,360 Patients Enrolled for Cigarette Smoking-Related Carcinoma
Jan BlalockPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
99 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
M D Anderson Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%