Bladder CancerNCT00310115
Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy
An observational study of Bladder Cancer and Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after pregnancy. PURPOSE: This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bladder Cancer, Cervical Cancer, Esophageal Cancer
- What is being tested?
- Counseling Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 469 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Aug 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Women, 18 years of age or older, who quit smoking while pregnant.
Who may be able to join
- age 18 or older
- former smoker who quit during pregnancy as assessed via self-report
- smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
- gestational age < 33 weeks and ability to attend an in-person visit at University of Texas MD Anderson Cancer Center (UTMDACC) between 30-33 weeks of gestational age
- can speak, read and write in English.
- must have a functioning home or personal cell phone
Who cannot join
- 1) high-risk pregnancy or known negative birth outcome
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: Smoking Relapse Prevention Among Postpartum Women
RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after pregnancy.
PURPOSE: This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy.
Read the detailed description
OBJECTIVES:
- Develop and evaluate 2 "Motivational Relapse Prevention" (MRP) treatments of varying intensity for reducing postpartum smoking relapse among pregnant women who quit smoking during pregnancy.
- Assess MRP and Enhanced MRP (MRP+) effects on treatment mechanisms and the role of those mechanisms in mediating MRP and MRP+ effects on abstinence.
- Assess the cost-effectiveness of both the MRP and MRP+ treatments relative to each other and to usual care for reducing postpartum smoking relapse.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 intervention arms.
- Arm I (usual care [UC]): Participants receive self-help materials and brief relapse prevention advice based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.
- Arm II (motivational relapse prevention [MRP]): Participants receive the same intervention as in arm I. Participants also undergo telephone counseling over 30 minutes at 34 and 36 weeks gestation and then at 2, 4, 7, and 16 weeks postpartum.
- Arm III (enhanced MRP [MRP+]): Participants receive the same intervention as in arm I and telephone counseling as in arm II. Participants also undergo in-person counseling over 1 hour at 30-33 weeks gestation and then at 8 weeks postpartum.
Participants in all arms complete questionnaires at baseline, at 30-33 weeks gestation, and then at 8 and 26 weeks postpartum.
Participants are followed at 8 and 26 weeks postpartum.
PROJECTED ACCRUAL: A total of 450 participants will be accrued for this study.
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
- Being tested
- Smoking Prevention Usual Care, Counseling Intervention
- Keywords
- non-small cell lung cancer, small cell lung cancer, bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, pancreatic cancer, hypopharyngeal cancer, lip and oral cavity cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, adult acute myeloid leukemia, tobacco use disorder
- Medical subject headings
- Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Leukemia, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Prevention Usual CareBehavioural
Usual care of self-help materials and advice for staying cigarette free
Counseling InterventionBehavioural
6 x 30 minute counseling sessions over the telephone
Counseling InterventionBehavioural
2 in-person counseling sessions
| Study group | Role | What they receive |
|---|---|---|
| Smoking Prevention Usual Care | Arm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline. Receives: Behavioral: Smoking Prevention Usual Care | |
| MRP | Arm II (motivational relapse prevention [MRP]): Same intervention as usual care, plus 30 minutes telephone counseling at 34 \& 36 weeks gestation then at 2, 4, 7, \& 16 weeks postpartum. Receives: Behavioral: Smoking Prevention Usual Care; Behavioral: Counseling Intervention | |
| Enhanced MRP + | Arm III (enhanced MRP [MRP+]): Same intervention as usual care and telephone counseling as MRP, plus 1 hour in-person counseling at 30-33 weeks gestation \& 8 weeks postpartum. Receives: Behavioral: Smoking Prevention Usual Care; Behavioral: Counseling Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Smoking Abstinence
Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment
Measured: 26 weeks
Secondary outcomes (1)
Number of Cigarettes Smoked Daily
Cigarettes smoked per day at 26 weeks following study treatment
Measured: 26 weeks following study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startApr 2002
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 469 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
- David Wetter, PhD, BS, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310115
- Sponsor's protocol ID
- BS01-178
- Other IDs
- R01CA089350, P30CA016672, MDA-BS01-178, CDR0000466327, NCI-2010-01136
- Status last verified
- Sep 2016
- First submitted
- 29 Mar 2006
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Relapse Prevention Among Postpartum Women
- ClinicalTrials.gov ID
- NCT00310115
- Acronym / sponsor ID
- BS01-178
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer
- Keywords
- non-small cell lung cancer, small cell lung cancer, bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2002
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Apr 2006 (estimated)
- 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.
RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after pregnancy.
PURPOSE: This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy.
Detailed description
OBJECTIVES:
- Develop and evaluate 2 "Motivational Relapse Prevention" (MRP) treatments of varying intensity for reducing postpartum smoking relapse among pregnant women who quit smoking during pregnancy.
- Assess MRP and Enhanced MRP (MRP+) effects on treatment mechanisms and the role of those mechanisms in mediating MRP and MRP+ effects on abstinence.
- Assess the cost-effectiveness of both the MRP and MRP+ treatments relative to each other and to usual care for reducing postpartum smoking relapse.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 intervention arms.
- Arm I (usual care [UC]): Participants receive self-help materials and brief relapse prevention advice based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.
- Arm II (motivational relapse prevention [MRP]): Participants receive the same intervention as in arm I. Participants also undergo telephone counseling over 30 minutes at 34 and 36 weeks gestation and then at 2, 4, 7, and 16 weeks postpartum.
- Arm III (enhanced MRP [MRP+]): Participants receive the same intervention as in arm I and telephone counseling as in arm II. Participants also undergo in-person counseling over 1 hour at 30-33 weeks gestation and then at 8 weeks postpartum.
Participants in all arms complete questionnaires at baseline, at 30-33 weeks gestation, and then at 8 and 26 weeks postpartum.
Participants are followed at 8 and 26 weeks postpartum.
PROJECTED ACCRUAL: A total of 450 participants will be accrued for this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smoking Prevention Usual Care | – | Behavioral: Smoking Prevention Usual CareArm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline. |
| MRP | – | Behavioral: Smoking Prevention Usual Care, Behavioral: Counseling InterventionArm II (motivational relapse prevention [MRP]): Same intervention as usual care, plus 30 minutes telephone counseling at 34 \& 36 weeks gestation then at 2, 4, 7, \& 16 weeks postpartum. |
| Enhanced MRP + | – | Behavioral: Smoking Prevention Usual Care, Behavioral: Counseling InterventionArm III (enhanced MRP [MRP+]): Same intervention as usual care and telephone counseling as MRP, plus 1 hour in-person counseling at 30-33 weeks gestation \& 8 weeks postpartum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women, 18 years of age or older, who quit smoking while pregnant.
Key inclusion criteria (6 listed)
- age 18 or older
- former smoker who quit during pregnancy as assessed via self-report
- smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
- gestational age < 33 weeks and ability to attend an in-person visit at University of Texas MD Anderson Cancer Center (UTMDACC) between 30-33 weeks of gestational age
- can speak, read and write in English.
Key exclusion criteria (1 listed)
- 1) high-risk pregnancy or known negative birth outcome
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 |
|---|---|---|
| Smoking Prevention Usual CareUsual care of self-help materials and advice for staying cigarette free | Behavioural | Enhanced MRP +, MRP, Smoking Prevention Usual Care |
| Counseling Intervention6 x 30 minute counseling sessions over the telephone | Behavioural | Enhanced MRP +, MRP |
| Counseling Intervention2 in-person counseling sessions | Behavioural | Enhanced MRP + |
Primary outcome
Number of Patients with Smoking Abstinence
Time frame: 26 weeks
Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment
1 secondary outcome
Number of Cigarettes Smoked Daily
Time frame: 26 weeks following study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast 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.
David Wetter, PhD, BS, BA 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?
An observational study of Bladder Cancer and Cervical Cancer, 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 23 Sep 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Patients with Smoking Abstinence (time frame: 26 weeks). 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 23 Sep 2016.