NCT03316170|CompletedPhase 2ResultsFDA Drug
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Sponsor study identifier
interventional
49
1 country
1
Study Start
November 6, 2017
Actual (reported)Primary Completion
March 31, 2020
Actual (reported)Study Completion
March 31, 2020
Actual (reported)The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and acceptability of a new approach to smoking cessation induction treatment in cancer survivors with low social resources, and 2) To assess the effectiveness of said treatment for key events in the process of smoking cessation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2017
Actual (reported)October 20, 2017
Actual (reported)November 6, 2017
Actual (reported)March 31, 2020
Actual (reported)March 31, 2020
Actual (reported)July 8, 2021
Actual (reported)Accrual Percentage
Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100
Day 0 baseline
Retention
Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100
Through study completion, number of assessments at Day 60 follow-up
Acceptability
Total score on the Treatment Acceptability and Preferences measure (Sidani et al., 2009). This is a 4-item measure with each item scored on a scale from 0 to 4. Total scores are computed as the mean of the 4 individual items, so total scores range from 0 to 4. Higher scores indicate a better outcome, as they reflect greater acceptability of the treatment provided in this clinical trial.
Day 60 follow-up
The treatment group will receive: 1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, 2. a written directory of a range of social support resources delivered via mail, 3. a brief phone consult (10-15 minutes via phone) germane to smoking cessation, 4. a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and 5. a free, 2-week supply of nicotine patches and lozenges delivered via mail.
The control group will receive: 1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, 2. a written directory of a range of social support resources delivered via mail,
A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536, United States
Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.
Jessica Burris, Ph.D.
University of Kentucky
49 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2017
First Posted
October 20, 2017
Study Start
November 6, 2017
Actual (reported)Combining Varenicline and Guanfacine for Smoking Cessation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2020
Actual (reported)Study Completion
March 31, 2020
Actual (reported)Last Updated
July 8, 2021
Results First Posted
July 8, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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