Validation of PROMIS emotional distress short form scales for cervical cancer

Objectives. Cervical cancer patients are at high risk for emotional distress. In this study we evaluate the PROMIS emotional distress-Depression and -Anxiety Short Forms for assessing depression and anxiety in a cervical cancer population. Methods. A 15-item questionnaire was used in a cervical cancer biobehavioral randomized clinical trial, testing psychosocial telephone counseling (PTC) against usual care (UC). It was administered to 204 patients prior to randomization, four months post-enrollment, and nine months post-enrollment, together with legacy measures of depression. The short forms were evaluated in patients participating in this study over three time points for internal consistency, convergent validity, and responsiveness to change over time. Results. Overall, 45% and 47% of patients scored in the moderate to severe range for anxiety and depression, respectively. Internal consistency coefficients were >= 0.95 at baseline, 4 months, and 9 months for depression and anxiety. The average inter-item correlation was 0.65 and 0.73 at baseline assessment for depression and anxiety, respectively. The depression short form T-score was correlated with legacy distress scales ranging from 0.44-0.76, and the anxiety short form ranging from 0.45-0.78. The depression short form demonstrated sensitivity to change as patients randomized to the counseling intervention reported greater improvement over time in depression (p = 0.014), and a nonsignificant improvement in anxiety, compared to the patients receiving usual care. Conclusions. The PROMIS depression and anxiety short forms reliably and validly assess cervical cancer-specific emotional distress, capture salient features of distress in this population, and perform as well or better than legacy measures. (C) 2018 Elsevier Inc. All rights reserved.