Karen Suchanek Hudmon

Validation of the modified Fagerstrom Tolerance Questionnaire with salivary cotinine among adolescents

This study was conducted to gain evidence of validity for a nicotine dependence measure for adolescent smokers. We hypothesized that the individual item responses and the total Fagerström Tolerance Questionnaire (FTQ) score would be positively correlated with cotinine values. We examined the relationship between a seven-item modified FTQ and saliva continine among 131 adolescent volunteers in a smoking cessation program. As anticipated, the total FTQ score was related to saliva cotinine (r = .40, p < .01), as were six of the seven individual FTQ items (p < .05). Our findings provide preliminary evidence that the modified FTQ scale is valid and applicable to adolescent smokers.

Eating orientation, postcessation weight gain, and continued abstinence among female smokers receiving an unsolicited smoking cessation intervention.

Predictors of weight gain following smoking cessation were assessed among 1,219 female smokers enrolled in a health maintenance organization. Women randomized to the treatment group received a cessation intervention without regard to their interest in quitting smoking. It was hypothesized that cessation would result in subsequent weight gain and postcessation weight gain would be associated with scores on a modified Restraint Scale, the Disinhibition Scale, and a scale assessing tendency to eat during periods of negative affect. Persons who abstained from smoking over the 18-month study gained more weight than did intermittent smokers and continuous smokers, and among 762 women who reported at least 1 on-study attempt to quit smoking, 36% gained weight. Weight gain was associated with disinhibited eating and negative affect eating but not with restrained eating. Weight gain also was associated with continued abstinence from smoking.

Participants' perceptions of a phase I colon cancer chemoprevention trial

To assess participants perceptions of a phase I colon cancer chemoprevention trial using a calcium intervention, questionnaires were mailed to trial participants at the conclusion of the study. Responses to questionnaire items reported here include (1) perceived benefits and barriers of participation, (2) interest in participating in future trials, (3) willingness to pay trial expenses out of pocket, and (4) posttrial continuation of the calcium regimen. The study found that the most highly rated trial benefit was the perception of potential colon cancer prevention; the trial barrier reported to be the most troublesome was inappropriate or mistaken billing for study visits. Three fourths of the subjects expressed an interest in future trials of the same duration. For trials of longer duration, this percentage decreased to 66%. Approximately half did not object to participation in future trials involving placebos, and just over one third indicated that they would either definitely (8%) or probably (27%) have joined the calcium trial even if they had to pay some study expenses out of pocket. Over 90% indicated they would continue taking the calcium pills if calcium is shown to be effective. The level of perceived benefits was positively associated with reported interest in participating in future trials of the same and longer durations, and the level of reported difficulty with trial pills and procedures was inversely related to interest in future placebo-controlled trials. The results of this study, in conjunction with results of prospective studies of trial participation, may be applied in future chemoprevention trials to facilitate recruitment, reduce attrition, and promote positive trial experiences for participants by emphasizing frequently reported benefits and minimizing frequently reported barriers.

Outcomes of a placebo run-in period in a head and neck cancer chemoprevention trial

This study describes the outcomes of an eight-week placebo run-in period in a head and neck cancer chemoprevention trial. Of 391 former cancer patients who entered the run-in over the first two years of the trial, 91% were randomized. Pill counts showed that adherence rates ranged from 0% to 120% (mean 96%, SD = 15%). The trial did not randomize subjects who were no longer interested in trial participation (n = 20), who did not return within 10 weeks of enrollment date (n = 3), or who did not achieve a drug adherence level of at least 75% (n = 9). Three subjects were not randomized for other reasons. Univariate predictors of run-in outcome (randomized or not randomized) included ethnicity, education level, cancer site, cancer stage, and Karnofsky performance score. Multivariate analyses resulted in a logistic model with Karnofsky performance and education level as significant predictors of randomization. Persons with a Karnofsky score of 100 had 2.3 higher odds of randomization (95% CI = 1.1, 4.9) than persons with compromised Karnofsky scores, and persons with more than a high school education had 2.1 higher odds of randomization (95% CI = 1.0, 4.9) than persons with less education. These results suggest that the use of a run-in period may compromise the external validity of randomized prevention trials. More research is needed to understand further the behavioral factors underlying the observed differences so that prevention researchers can develop effective interventions for facilitating trial participation, especially in under-represented, trial-eligible groups. Investigators should expand the objectives of a run-in period to (1) evaluate why eligible persons refuse trial enrollment or fail to be randomized at the end of the run-in and (2) use the run-in period for a systematic evaluation of levels and costs of intervention strategies designed to promote trial enrollment and adherence.