Cigarette Smoking-Related CarcinomaNCT05051345
Increasing Access to Smoking Cessation and Smoke Free Home Services for Low-Income Pregnant Women in Northeast Texas
A study testing Informational Intervention, Media Intervention and Questionnaire Administration in people with Cigarette Smoking-Related Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial seeks to increase access to smoking cessation services to low-income pregnant women. Smoking is associated with an increased risk of developing cancer. Smoking during pregnancy smoking is associated with an increased risk of low birth weight, a condition that is associated with neonatal, perinatal, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Informational Intervention, Media Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 8 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Currently pregnant
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Currently receiving services at one of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) or Federally Qualified Health Centers (FQHC) clinics listed in the protocol
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Self-report being a current smoker, having quit for the pregnancy or allowing smoking in the home
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Reside in Texas
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Consent to take surveys
- PRE-TEST SURVEY FOR PREGNANT WOMEN: English or Spanish speaking
Show all 19Show fewer
- SERVICES OFFERED TO PREGNANT WOMEN: Currently pregnant or within the first 4 months of postpartum period
- SERVICES OFFERED TO PREGNANT WOMEN: Self-report that they are currently receiving services at one of the WIC or FQHC clinics listed in the protocol
- SERVICES OFFERED TO PREGNANT WOMEN: Self-report being a current smoker, having quit for the pregnancy or allowing smoking in the home
- SERVICES OFFERED TO PREGNANT WOMEN: Reside in Texas
- SERVICES OFFERED TO PREGNANT WOMEN: Willing to provide address, telephone contact or download app onto their smartphones
- SERVICES OFFERED TO PREGNANT WOMEN: English or Spanish speaking
- HOUSEHOLD MEMBERS OF PREGNANT WOMEN: Self-report that he/she currently smokes and lives in the household with the pregnant woman who is receiving services
- HOUSEHOLD MEMBERS OF PREGNANT WOMEN: Reside in Texas
- HOUSEHOLD MEMBERS OF PREGNANT WOMEN: English or Spanish speaking
- SERVICES OFFERED TO NON-PREGNANT INDIVIDUALS: Currently receiving services at one of the WIC or FQHC clinics listed in the protocol
- SERVICES OFFERED TO NON-PREGNANT INDIVIDUALS: Self-report being a current smoker or allowing smoking in the home
- SERVICES OFFERED TO NON-PREGNANT INDIVIDUALS: Reside in Texas
- SERVICES OFFERED TO NON-PREGNANT INDIVIDUALS: English or Spanish speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This trial seeks to increase access to smoking cessation services to low-income pregnant women. Smoking is associated with an increased risk of developing cancer. Smoking during pregnancy smoking is associated with an increased risk of low birth weight, a condition that is associated with neonatal, perinatal, and infant morbidity and mortality. The overall goal of this trial is to help patients make healthy choices and provide support during pregnancy and in the first few months after the birth of the baby.
Read the detailed description
PRIMARY OBJECTIVES:
- Establish proactive referral to services. II. Provide access to evidence-based counseling and app-based smoking cessation, relapse prevention services, and counseling to household members of pregnant women who smoke III. Provide access to smoke free homes intervention. IV. Provide access to evidence-based counseling for non-pregnant smokers and access to smoke free homes intervention for non-pregnant individuals who have smoking in the home.
OUTLINE:
GOAL 1: Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation.
GOAL 2: 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.
GOAL 3: 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.
GOAL 4: Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Informational Intervention, Media Intervention, Questionnaire Administration, Smoking Cessation Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive information on the services provided for pregnant women and smoking cessation
Informational InterventionOther
Receive tobacco cessation self-help materials
Informational InterventionOther
Receive Smoke-Free Homes mailings
Media InterventionOther
Download and use the Wellness app
Questionnaire AdministrationOther
Ancillary studies
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Receive Smoke-Free Homes kit
Survey AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive telephone counseling sessions
Telephone-Based InterventionBehavioural
Receive a coaching call from a Baby Steps for Health counselor
Tobacco Cessation CounselingOther
Receive telephone counseling sessions
| Study group | Role | What they receive |
|---|---|---|
| Goal 1 (Wellness app) | Experimental | Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation. Receives: Other: Informational Intervention; Other: Media Intervention; Other: Questionnaire Administration; Other: Survey Administration |
| Goal 2 (counseling, Wellness app, self-help) | Experimental | 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. Receives: Other: Informational Intervention; Other: Media Intervention; Other: Questionnaire Administration; Other: Survey Administration; Behavioral: Telephone-Based Intervention; Other: Tobacco Cessation Counseling |
| Goal 3 (Smoke-free Homes) | Experimental | 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. Receives: Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
| Goal 4 (counseling) | Experimental | Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period. Receives: Other: Questionnaire Administration; Other: Survey Administration; Behavioral: Telephone-Based Intervention; Other: Tobacco Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide proactive referral to services to participants
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start18 Feb 2020
- Primary completion8 May 2026
- Study completion8 May 2026
Why it stopped: \< 75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jan Blalock, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051345
- Sponsor's protocol ID
- 2018-0901
- Other IDs
- NCI-2020-07338, 2018-0901
- Status last verified
- May 2026
- First submitted
- 5 Oct 2020
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Smoking Cessation and Smoke Free Home Services for Low-Income Pregnant Women in Northeast Texas
- ClinicalTrials.gov ID
- NCT05051345
- Acronym / sponsor ID
- 2018-0901
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \< 75% participation
- Enrolment
- 191 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial seeks to increase access to smoking cessation services to low-income pregnant women. Smoking is associated with an increased risk of developing cancer. Smoking during pregnancy smoking is associated with an increased risk of low birth weight, a condition that is associated with neonatal, perinatal, and infant morbidity and mortality. The overall goal of this trial is to help patients make healthy choices and provide support during pregnancy and in the first few months after the birth of the baby.
Detailed description
PRIMARY OBJECTIVES:
- Establish proactive referral to services. II. Provide access to evidence-based counseling and app-based smoking cessation, relapse prevention services, and counseling to household members of pregnant women who smoke III. Provide access to smoke free homes intervention. IV. Provide access to evidence-based counseling for non-pregnant smokers and access to smoke free homes intervention for non-pregnant individuals who have smoking in the home.
OUTLINE:
GOAL 1: Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation.
GOAL 2: 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.
GOAL 3: 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.
GOAL 4: Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Goal 1 (Wellness app) | Experimental | Other: Informational Intervention, Other: Media Intervention, Other: Questionnaire Administration, Other: Survey AdministrationParticipants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation. |
| Goal 2 (counseling, Wellness app, self-help) | Experimental | Other: Informational Intervention, Other: Media Intervention, Other: Questionnaire Administration, Other: Survey Administration, Behavioral: Telephone-Based Intervention, Other: Tobacco Cessation CounselingParticipants 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. |
| Goal 3 (Smoke-free Homes) | Experimental | Other: Informational Intervention, Other: Questionnaire Administration, Behavioral: Smoking Cessation Intervention, Other: Survey Administration, Behavioral: Telephone-Based InterventionParticipants 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. |
| Goal 4 (counseling) | Experimental | Other: Questionnaire Administration, Other: Survey Administration, Behavioral: Telephone-Based Intervention, Other: Tobacco Cessation CounselingNon-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Currently pregnant
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Currently receiving services at one of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) or Federally Qualified Health Centers (FQHC) clinics listed in the protocol
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Self-report being a current smoker, having quit for the pregnancy or allowing smoking in the home
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Reside in Texas
- PRE-TEST SURVEY FOR PREGNANT WOMEN: Consent to take surveys
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational InterventionReceive information on the services provided for pregnant women and smoking cessation | Other | Goal 1 (Wellness app) |
| Informational InterventionReceive tobacco cessation self-help materials | Other | Goal 2 (counseling, Wellness app, self-help) |
| Informational InterventionReceive Smoke-Free Homes mailings | Other | Goal 3 (Smoke-free Homes) |
| Media InterventionDownload and use the Wellness app | Other | Goal 1 (Wellness app), Goal 2 (counseling, Wellness app, self-help) |
| Questionnaire AdministrationAncillary studies | Other | Goal 1 (Wellness app), Goal 2 (counseling, Wellness app, self-help), Goal 3 (Smoke-free Homes), Goal 4 (counseling) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsReceive Smoke-Free Homes kit | Behavioural | Goal 3 (Smoke-free Homes) |
| Survey AdministrationAncillary studies | Other | Goal 1 (Wellness app), Goal 2 (counseling, Wellness app, self-help), Goal 3 (Smoke-free Homes), Goal 4 (counseling) |
| Telephone-Based InterventionReceive telephone counseling sessions | Behavioural | Goal 2 (counseling, Wellness app, self-help), Goal 4 (counseling) |
| Telephone-Based InterventionReceive a coaching call from a Baby Steps for Health counselor | Behavioural | Goal 3 (Smoke-free Homes) |
| Tobacco Cessation CounselingReceive telephone counseling sessions | Other | Goal 2 (counseling, Wellness app, self-help), Goal 4 (counseling) |
Primary outcome
To provide proactive referral to services to participants
Time frame: Through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: \< 75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Cigarette Smoking-Related Carcinoma
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
RecruitingPhase 3
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Cigarette Smoking-Related Carcinoma
Not yet recruitingPhase 3
iCanQuit Smoking Cessation Among Hispanic Adults
Cigarette Smoking-Related Carcinoma
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
RecruitingEarly Phase 1
Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
Cigarette Smoking-Related Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Blalock principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Intervention, Media Intervention and Questionnaire Administration in people with Cigarette Smoking-Related Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: \< 75% participation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide proactive referral to services to participants (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.