Quitting Schedule Mobile Smartphone Application in Helping Participants to Quit Smoking

• ClinicalTrials.gov Identifier: NCT03668769
• Recruitment Status: Active, not recruiting
• First Posted: September 13, 2018
• Last Update Posted: January 2, 2020
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: September 11, 2018
• First Posted Date: September 13, 2018
• Last Update Posted Date: January 2, 2020
• Actual Study Start Date: March 27, 2017
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 29, 2018)

• 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 ]
• 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.

Original Primary Outcome Measures (submitted: September 11, 2018)

• 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 ]
• Pre-testing of the app [ Time Frame: Up to 5 weeks ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Quitting Schedule Mobile Smartphone Application in Helping Participants to Quit Smoking
• Official Title: Project Quitting Schedule
• 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Cigarette Smoker
• Current Every Day Smoker
• Current Smoker
• Malignant Neoplasm

Intervention

• 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

Study Arms

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.

Interventions:

• Other: Internet Mobile Technology
• Other: Interview
• Other: Questionnaire Administration
• Behavioral: Smoking Cessation Intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: December 29, 2019): 19
• Original Estimated Enrollment (submitted: September 11, 2018): 20
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: M.D. Anderson Cancer Center
• Study Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Paul Cinciripini; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: December 2019