Carroll 2019.
Study characteristics | ||
Methods |
Study design: secondary analysis of RCT Country: USA Data collection period: May 2013 – June 2017 Registry ID: ClinicalTrials.gov: NCT01756885 (primary RCT) |
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Participants |
Number of participants: N = 119; Number included in meta‐analysis: not clear for PANAS‐N (somewhere between 82 and 132), N = 117 for PANAS‐P Sample characteristics (at baseline): Age (mean): non‐adherent 58.6 years (SD 9.0), adherent 59.4 years (SD 8.4); Sex (% male): non‐adherent 48% (11/23), adherent 51% (49/96) Population category: chronic physical condition; Specific population: diagnosed with cancer within 5 years Nicotine dependence: FTCD non‐adherent 4.7 (SD 2.5), adherent 4.4 (SD 2.1); baseline cigarettes per day: not presented; Motivation to quit: selected by motivation to quit |
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Interventions |
Behavioural support for smoking cessation: smoking cessation counselling (based on PHS guidelines) Pharmacological support for smoking cessation: varenicline following standard dosing (0.5 mg once per day days 1 – 3, 0.5 mg twice per day days 4 – 7, increasing to 1.0 mg twice per day for remainder of treatment) Psychotherapeutic or psychoactive support for mental health or mood: did not receive mood management |
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Outcomes |
Definition of cessation used: 24‐hour point‐prevalence abstinence (i.e. not a cigarette, even a puff in past 24 hours) Cessation definition used for outcome(s) in this analysis: point‐prevalence abstinence Measure of biovalidation: not bioverified Definition of people who continue to smoke used: smoking a cigarette in previous 24 hours Time point(s) at which follow‐up was conducted: week 1 (target quit day), week 4, week 8 and week 12 after pre‐quit baseline (week 0) Outcome category: Mixed Depression and Anxiety, Positive Affect Outcome measure(s): Positive and Negative Affect Schedule (PANAS; negative and positive affect subscales) |
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Funding source | This research was supported by grants from the National Cancer Institute (R01 CA165001; R01 CA184211) and the National Institute on Drug Abuse (K24 DA045244). NCI and NIDA had no role in the study design, collection, analysis or interpretation of the data, writing the manuscript, or the decision to submit the paper for publication | |
Author conflicts of interest | Dr. Schnoll receives medication and placebo free from Pfizer; Dr. Schnoll has provided consultation to Pfizer and GlaxoSmithKline, and consults with Curaleaf; all other authors declare that they have no conflicts of interest | |
Notes | Outcome data source: Published and unpublished data |