High-Risk Cancer Clinical Trial
Official title:
Adjunctive Smart Phone Based Smoking Cessation Treatment
Verified date | January 2019 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Participants will be recruited for the current study during their initial orientation visit to the Parkland Health and Hospital System, Stop Smoking Class and Clinic every Monday morning. Individuals who are interested and eligible for participation in this study will receive uC (Parkland smoking cessation program), plus a tailored, adaptive, smart phone delivered smoking cessation intervention. Participants will be followed weekly from 1 week pre-quit through 4 weeks post-quit. all participants will be asked to attend 6 weekly visits, 4 of these visits will include a thorough assessment that may be completed either before or after their scheduled Parkland treatment appointments. All participants will receive a smartphone at the 1 week pre-quit visit and they will be asked to carry it with them at all times. Participants will complete eMa assessments 5 times per day (4 random assessments + 1 daily dairy) for three consecutive weeks. Geographic location coordinates will be captured during each eMa assessment to link characteristics of the neighborhood environment (e.g., neighborhood socioeconomic status, proximity to tobacco outlets) with cessation-related outcomes. Participants will be compensated upon the return of the smartphone at visit 4 (2 weeks post-quit). Participants will be asked to attend a follow-up visit 12 weeks after their quit date. At this visit, participants will complete additional questionnaires and their smoking status will be assessed. Expired carbon monoxide and weight will also be measured.
Status | Completed |
Enrollment | 75 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Participants will be included in the study if they: 1. earn a score greater than or equal to 4 on the Short REALM indicating greater than 6th grade English literacy level, 2. are willing to quit smoking 7 days from their first visit, 3. are greater than or equal to 18 years of age, 4. have an expired CO level greater than or equal to 8 ppm suggestive of current smoking, 5. are currently smoking greater than or equal to 5 cigarettes per day, 6. are willing and able to attend 6 weekly sessions (i.e., week -1, quit day, week +1, week +2, week +3, week +4) and the 12 week follow-up session , and 7. have not previously participated in Project PREVAIL [STU 042011-096] at Parkland Hospital. Please note that the Parkland smoking cessation program (usual care) is currently offered in English only. Exclusion Criteria: Participants will be excluded from the study if they: 1. are unwilling to quit smoking 7 days from their first visit, 2. have already quit smoking, 3. earn a score less than 4 on the Short REALM indicating less than or equal to 6th grade literacy level, 4. produce an expired CO level less than 8 ppm, 5. are currently smoking less than 5 cigarettes per day, 6. are unwilling or unable to attend 7 assessment sessions, 7. are less than 18 years of age, and/or 8. have not previously participated in Project PREVAIL [STU 042011-096] at Parkland Hospital. Please note that the Parkland smoking cessation program (usual care) is currently offered in English only. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking abstinence | Evidence of abstinence from smoking confirmed by questionnaire. | 12 weeks |
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