Abstract

6132 Background: Women with cervical cancer experience numerous quality of life (QOL) disruptions. A completed pilot study indicated that QOL and key biomarkers could be improved with psychosocial telephone counseling (PTC). A confirmatory trial has recently completed accrual.The purpose of this study is to identify predictors of retention in this large biobehavioral trial, and examine retention differences between the pilot and confirmatory trial. Methods: Women with stage I – III cervical cancer diagnosed 9 – 30 months earlier were randomized to either PTC or usual care. PROs and biological specimens were collected prior to randomization (N=204), and 3 (T2) and 9 months post baseline. Sociodemographic, clinical and QOL variables were evaluated from baseline to T2 to identify predictors of study retention. Multiple measures, including the PROMIS Depression and Anxiety scales were entered into a multivariate stepwise logistic regression model to predict study retention. Results: In the multivariate model, being randomized to counseling (OR=4.4, 95% CI: 1.5-12.6), having clinically significant depression, defined as >1 SD above the 50th percentile (OR=4.2, 95% CI:1.7-10.5) and being single (OR=3.4, 95% CI: 1.3-9.2) were the most significant predictors of drop-out in the study overall. Among those in the counseling arm, depression is the strongest predictor of dropout, with a five times higher dropout rate (OR=5.2, 95% CI:1.9-15.6) than those with low to moderate levels of depression, or no depression. However, retention rates improved substantially overall from the pilot study (72%) to the confirmatory study (84%), in both study arms, and retention increased among Latinas from 60% in the pilot study to 83% in the current study, and from 52% to 81% among those with less than a high school education. Conclusions: Results from this analysis of predictors of retention indicate that enhanced attention to sociocultural disparities can improve study retention. Attending to baseline clinical depression may be a further consideration.

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