Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

All Conditions

Acquired Immunodeficiency Syndrome

HIV Infections

HIV Seropositivity

All Drugs and Chemicals

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.

Participants receive weekly assessments to complete for the 8-week treatment period via smartphone.

Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.

Participants complete saliva cotinine test 3 months after intervention.

Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.

Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months.

Participants complete saliva cotinine test 3 months after intervention.

Participants receive an 8 week supply of Nicotine patches.

Nicotine Patch

Questionnaire completion at baseline on laptop, then weekly for 8 weeks on smartphone, then 3 months after smartphone intervention.

Questionnaires

Pamphlet given to participant describing health and financial reasons to quit smoking.

Pamphlet

Standard Treatment (ST) Group: Participants receive 8 phone counseling sessions (one session per week) for support in quitting smoking. The calls should last about 15 minutes.

Automated Treatment (AT) Group: Participants receive brief video clips with advice on how to quit smoking over smartphone, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.

Participants also have access to additional counseling content on the smart phone, which can be used at any time.

Phone Counseling Sessions

Participants complete saliva cotinine test 3 months after intervention.

Saliva Test

Standard Treatment (ST) Group: Participants receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.

Automated Treatment (AT) Group: Participants receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.

Smart phone

Diana S. Hoover, PHD

The goal of this research study is to learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.

Baseline Questionnaire:

If you agree to take part in this study, you will complete a questionnaire on a laptop about your feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, smoking history, and some demographic information such as age, education level, and income level. This should take about 15-20 minutes to complete.

Study Groups:

After completing the questionnaire, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being placed in either group.

Both groups will receive smart phones and an 8-week supply of nicotine patches with instructions on how to use them. Each group will receive different methods of advice for quitting smoking.

If you are assigned to Group 1, the following study procedures will be performed:

* You will receive brief advice on how to quit smoking once at the time of enrollment. The advice will be given from a pamphlet that has information such as health problems related to smoking, how many Americans are affected each year, financial problems related to smoking, nicotine replacement therapy options, preparation for quitting smoking, and encouragement to quit.
* On the smart phone, you will have 5 phone counseling sessions for support in quitting smoking throughout the 8-week intervention treatment. The calls should last about 15 minutes.

If you are assigned to Group 2, the following study procedures will be performed:

* On the smart phone, you will receive brief video clips with advice on how to quit smoking, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.
* You will also have access to additional counseling content on the smart phone, which you can use at any time.

Weekly Smart Phone Questionnaires:

Both groups will complete questionnaires on the smart phone every week for 8 weeks. Each questionnaire will have questions about your current smoking status, your motivation level to stop smoking, and things that may have a negative effect on your quitting. The questionnaire should take about 15 minutes to complete.

Follow-up Saliva Test and Questionnaire:

About 3 months after your first smart phone intervention, both groups will complete a saliva test and take a photograph of the test results. The saliva test results will be used to check your smoking activity. Supplies and instructions will be given to you when you are enrolled on the study and the instructions will be available on the smart phone. You will also complete a questionnaire similar to the baseline questionnaire.

Length of Study:

You will be on study for about 3 months.

This is an investigational study. Up to 50 participants will take part in this study. All will be enrolled at the Harris Health System (Thomas Street Health Center).

Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study

Mobile Smoking Cessation Treatment for Underserved Smokers: A Pilot and Feasibility Study

Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.

M.D. Anderson Cancer Center

Participants receive 15-minute proactive weekly phone counseling sessions via smartphone along with supply of nicotine patches for 8-week period to support quitting smoking.

Standard Treatment (ST)

Participants receive brief weekly advice (tailored 5 minute video clips) and 8-week automated intervention (interactive text messages and graphical messages via smartphone) along with supply of nicotine patches for 8-week period to support quitting smoking.

Automated Treatment (AT)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Early termination leading to small number of subjects registered, study halted without analysis.

Dr. Lorna McNeill, MPH,PHD/ Chair, Health Disparities Research

Data were not collected due to early termination of the protocol

Smoking Abstinence: 3-month Assessment Via Smart Phone

Overall Study

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Integrated intervention of smoking cessation and breastfeeding

Instructions on general pregnancy and infant care

The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.

Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

Attention placebo control

Xiaozhong Wen, MD, PhD

This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.

The investigators are proposing the first randomized controlled trial to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their 1st or 2nd trimester of pregnancy (≤28 weeks) from local obstetric clinics, communities, and social media. They will be randomized into either the intervention (N=20) or control group (N=20). The two groups will complete the same number of sessions (6 during pregnancy and 3 postpartum), but focus on different topics. Specifically, the control group will receive instructions on general pregnancy and infant care. The intervention group will receive instructions on general pregnancy and infant care, plus an integrated multicomponent intervention that promotes both smoking cessation and breastfeeding (i.e., education and counseling, monitoring and feedback, and contingent financial incentives). Two female Certified Lactation Counselors (interventionists) will be trained to run study sessions during home visits. Interventionists will provide additional support via phone and text messaging until 6 months postpartum. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum within the duration of this award.

The 40 eligible participants will be randomized into either the intervention (N=20) or control group (N=20). A sequence of random numbers in blocks of 2 will be used to ensure equal numbers of participants for each group over time.

Research staff who collect and analyze outcome data will be blinded to participants' group assignments.

Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding

Based on their recorded daily numbers of cigarettes and cigars smoked after enrollment, the investigators will classify smoking abstinence status in the past 7 days (7-day point-prevalence).60,61 The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (\<50 ng/mL).

During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II.

During postpartum, mothers will report breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum.

During postpartum, mothers will report breastfeeding frequency (times per day) every month until 6 months postpartum.

During postpartum, mothers will update breastfeeding duration (weeks) every month until 6 months postpartum.

During postpartum, mothers will update formula duration (weeks) every month until 6 months postpartum.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study	NCT02302859	Tobacco Use Ces...	Nicotine Patch Questionnaires Pamphlet Phone Counselin... Saliva Test Smart phone	18 Years -	M.D. Anderson Cancer Center
Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding	NCT05123118	Smoking, Cigare... Breastfeeding	Integrated inte... Attention place...	18 Years -	State University of New York at Buffalo
Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study	NCT02302859	Tobacco Use Ces...	Nicotine Patch Questionnaires Pamphlet Phone Counselin... Saliva Test Smart phone	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for smoking abstinence