Smoking Cessation for Cervical Cancer Survivors
Conditions
Cervical Cancer - Tobacco Use - Smoking Cessation
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervical Cancer, Cervical Cancer Survivors, Smoking Cessation, Motivation And Problem-Solving, MAPS, Saliva test, Self help materials, Pamphlets, Texas Quitline, Nicotine patch, Questionnaires, Surveys, Telephone counseling sessions
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Self-Help Materials Type: Behavioral
Name: Nicotine Patch Type: Drug
Name: Questionnaire Design System (QDS) Type: Behavioral
Name: Saliva Test Type: Procedure
Name: Telephone Counseling Sessions Type: Behavioral
Overall Status
Recruiting
Summary
The goal of this research study is to compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer to quit smoking.
Detailed Description
Study Groups:

If you agree to take part in this study, you will receive a phone call and will be randomly assigned (as in the flip of a coin) to 1 of 2 possible study groups:

- If you are in Group 1, you will receive free self-help materials, and a referral to the Quitline. The Quitline provides free quit smoking services to eligible callers.

- If you are in Group 2, you will receive free self-help materials, a referral to the Quitline, and 6 telephone counseling sessions over the next year.

You will have an equal chance of being in either group. No matter which group you are in, you will also receive a 6-week supply of the nicotine patch. The strength of the nicotine patches you receive will depend on how much you smoke each day. You should use the nicotine patch as directed by the package instructions.

Unused and used patches have enough nicotine to poison children and pets. Be sure to fold the sticky ends together when you are done using the patch. In case of accidental overdose, call your doctor or a poison control center right away.

Even if you do not wish to use the nicotine patch, you will still be allowed to take part in the study.

Study Questionnaires:

You will be asked to complete questionnaires over the phone 4 times:

- Month 3

- Month 6

- Month 12

- Month 18

During the calls, you will be asked about your feelings, moods, cervical cancer diagnosis, and smoking status. These calls should take about 20 to 35 minutes each time to complete.

Saliva Testing:

At Months 3, 6, 12 and 18, you may also be asked to provide a saliva sample to test for cotinine to confirm your smoking status. Cotinine is a chemical released in your body when it breaks down nicotine. You will receive a kit in the mail with supplies for testing. The research staff will call you to make sure that you received the kit and to discuss the instructions with you. If you have any questions about how to use the kit, you may contact the study staff during the study.

To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You will be asked to mail the saliva sample back to the research staff, using a prepaid return envelope. You may be contacted by mail, telephone, and/or email during the study to be given reminders to send back the kit.

Telephone Counseling:

If you are in Group 2, you will have 6 telephone counseling sessions that may last up to 30 minutes each. These calls will occur over a 12-month period at times that are convenient for you. During the calls, you will be asked about how motivated you are to quit smoking, what barriers to quitting you may have, and factors that may be related to your smoking such as stress and family issues.

These sessions will be digitally recorded. The recordings will be used to help the researchers make sure that the counselors are following the correct procedures and to help the investigators better understand or improve the counseling.

Length of the Study:

Your participation in the study will end when you complete the final questionnaire call at Month 18.

If you wish to leave the study early, you should tell the study staff that you want to stop taking part in this research study. Once you tell the study staff that you want to stop participating, you will not receive follow-up questionnaire phone calls.

This is an investigational study. The nicotine patch used in this study is FDA approved and commercially available.

Up to 350 participants overall will take part in this research study. All will be enrolled at MD Anderson.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

1. Harris Health System patient

2. 18 years of age or older

3. Self-reported current smoker

4. History of cervical cancer

5. Has a working telephone number

6. Has a valid home address

7. Speaks English, Spanish or both languages

Exclusion Criteria:

1. Active substance abuse or dependence

2. Regular use of tobacco products other than cigarettes

3. Current use of tobacco cessation medications

4. Self-report of being pregnant or lactating

5. Another household member enrolled in the study

6. Contraindication for nicotine patch use
Locations
Harris Health System
Houston, Texas, United States
Status: Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
January 2015
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page