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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07338 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0901 | Other Identifier | M D Anderson Cancer Center |
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< 75% participation
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Intervention | Other | Receive information on the services provided for pregnant women and smoking cessation |
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| Measure | Description | Time Frame |
|---|---|---|
| To provide proactive referral to services to participants | Through study completion, an average of 1 year |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Blalock | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2022 | May 12, 2026 |
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| Goal 4 (counseling) | Experimental | Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period. |
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| Informational Intervention | Other | Receive tobacco cessation self-help materials |
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| Informational Intervention | Other | Receive Smoke-Free Homes mailings |
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| Media Intervention | Other | Download and use the Wellness app |
|
| Questionnaire Administration | Other | Ancillary studies |
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| Smoking Cessation Intervention | Behavioral | Receive Smoke-Free Homes kit |
|
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| Survey Administration | Other | Ancillary studies |
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| Telephone-Based Intervention | Behavioral | Receive telephone counseling sessions |
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| Telephone-Based Intervention | Behavioral | Receive a coaching call from a Baby Steps for Health counselor |
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| Tobacco Cessation Counseling | Other | Receive telephone counseling sessions |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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