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Quitting Schedule Mobile Smartphone Application in Helping Participants to Quit Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668769
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well a mobile smartphone application called Quitting Schedule works in helping participants to quit smoking. Quitting Schedule is based on WebCASSI, a computer-based initiative that offered state of-the-art smoking cessation treatment and counseling to MD Anderson Cancer Center (MDACC) patients and served as a portal for non-patients to find information regarding smoking cessation advice and treatments. Quitting Schedule may help participants to quit smoking.

Condition or disease Intervention/treatment Phase
Cigarette Smoker Current Every Day Smoker Current Smoker Malignant Neoplasm Other: Internet Mobile Technology Other: Interview Other: Questionnaire Administration Behavioral: Smoking Cessation Intervention Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To adapt the internal algorithms of the scheduled reduced smoking approach in Computer Assisted Stop Smoking Intervention for the World Wide Web (WebCASSI) into a smartphone application (app): Quitting Schedule.

II. Once the smartphone app is developed, a pretesting phase with smoker seeking care at MDACC Tobacco Treatment Program or another community service such as Equality Texas, Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ) Advisory Board of the City of Houston, Montrose Center, Avenue 360 and Lesbian Health Initiative will follow.

III. To culturally and linguistically adapt Quitting Schedule app into Spanish language.

IV. To implement a feasibility trial in IDC (Colombia), INCan (Mexico), and INEN (Peru).

OUTLINE:

AIM I: Participants follow an individually tailored gradual reduction of smoking schedule for 5 weeks while MDACC eHealth adapts WebCASSI into a smartphone app: Quitting Schedule.

AIM II: Participants pre-test the Quitting Schedule mobile smartphone app for 5 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project Quitting Schedule
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Prevention (smoking reduction, Quitting Schedule mobile app)

AIM I: Participants follow an individually tailored gradual reduction of smoking schedule for 5 weeks while MDACC eHealth adapts WebCASSI into a smartphone app: Quitting Schedule.

AIM II: Participants pre-test the Quitting Schedule mobile smartphone app for 5 weeks.

Other: Internet Mobile Technology
Use Quitting Schedule mobile smartphone app
Other Name: www-mobile

Other: Interview
Ancillary studies

Other: Questionnaire Administration
Ancillary studies

Behavioral: Smoking Cessation Intervention
Participate in individual smoking cessation program
Other Name: Smoking and Tobacco Use Cessation Interventions




Primary Outcome Measures :
  1. Adaptation of the programmatic infrastructure of WebCASSI (Computer Assisted Stop Smoking Intervention for the World Wide Web) into a more-portable table and smartphone application (app) that will be available both in English and Spanish [ Time Frame: Up to 5 weeks ]
  2. Pre-testing of the app [ Time Frame: Up to 5 weeks ]
    A focus group will be used in order to provide feedback on the features of the app in relation to usability for smoking cessation and future app development.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current smokers (those who smoke at least 5 cigarettes a day; confirmed with carbon monoxide (CO) levels equal or above 7 parts per million ) newly enrolled in the Tobacco Treatment Program at MDACC (Aim 2 )
  • Male or female (Aim 2)
  • Adult cancer patients - 18 years or older (Aim 2)
  • Current smokers seeking care at the Tobacco Treatment Program at MD Anderson and at Houston area community services who have smoked at least 100 cigarettes in lifetime
  • Willing to download and use the app Quitting Schedule (Aim 2)
  • Willing to set a quit smoking date within 5 weeks of the enrollment (Aim 2)
  • Ownership of an iPhone or Android smartphone (Aim 2)

Exclusion Criteria:

  • Unwillingness to participate in the study (Aim 2)
  • Enrolled in another cessation program (Aim 2)
  • Current use of NRT or other smoking cessation medications,e.g. Varenicline or Bupropion outside of the MD Anderson Institution (Aim 2)
  • Expired CO levels below 7ppm (Aim 2)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668769


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Paul Cinciripini M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03668769    
Other Study ID Numbers: 2016-0516
NCI-2018-01820 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0516 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms