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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03668769
Other study ID # 2016-0516
Secondary ID NCI-2018-0182020
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 27, 2017
Est. completion date March 4, 2020

Study information

Verified date February 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 4, 2020
Est. primary completion date March 4, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Other:
Internet Mobile Technology
Use Quitting Schedule mobile smartphone app
Interview
Ancillary studies
Questionnaire Administration
Ancillary studies
Behavioral:
Smoking Cessation Intervention
Participate in individual smoking cessation program

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 5 weeks
Primary Pre-testing of the app 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. Up to 5 weeks
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