NCT03657511

Brief Summary

This study is planned as an evaluation of a low cost, simple smoking cessation intervention. There is very little information about the effectiveness of a simple tobacco cessation strategy. Therefore, our objective is to obtain estimates of effectiveness that can be used to refine existing programs or to develop new ones.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

2.7 years

First QC Date

August 31, 2018

Last Update Submit

May 5, 2022

Conditions

Keywords

Smoking

Outcome Measures

Primary Outcomes (1)

  • The number of women who quit smoking in the last 12 weeks

    Completion of second questionnaire to determine if participant is currently smoking or had quit smoking in the last 12 weeks.

    12 weeks after initial self-administered questionnaire

Secondary Outcomes (1)

  • The number of women who attempted to quit smoking in the last 12 weeks.

    12 weeks after initial self-administered questionnaire

Study Arms (1)

Educational Interventions to Promote Tobacco Cessation

OTHER
Behavioral: Educational Interventions to Promote Tobacco Cessation

Interventions

Women receiving a screening mammogram at KCI downtown and McLaren Macomb, will be given a self-administered questionnaire at check-in. Women who indicate they are current smokers are eligible for the study. After the screening mammogram is complete, eligible women will be consented. Educational materials will be provided to the participant at that time. The materials provided outline evidence-based approaches to smoking cessation and include contact information for local resources including cessation support groups, Michigan Tobacco Quitline, American Cancer Society's Guide to Quitting Smoking, Quitnet, Smokfree.gov and Become An Ex. The participant will be contacted by telephone approximately 12 weeks later to determine if she is currently smoking or had quit in the last 12 weeks.

Educational Interventions to Promote Tobacco Cessation

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand and read English

You may not qualify if:

  • Currently undergoing tobacco cessation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 5, 2018

Study Start

October 22, 2018

Primary Completion

June 21, 2021

Study Completion

June 21, 2021

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations