Improving treatment of depression among low-income patients with cancer: the design of the ADAPt-C study

ObjectiveThis article describes the randomized clinical trial methodology for a population-based study of oncology patients receiving cancer care in a public sector medical center. The primary goal is to test the effectiveness of socioculturally tailored collaborative care intervention in improving depression and quality of life outcomes among low-income ethnic minority patients with major depression and cancer.MethodsThe Patient Health Questionnaire (PHQ-9) depression scale was used to identify patients meeting criteria for major depression (one cardinal depression symptom plus a PHQ-9 score of ≥10). Study-eligible patients were ≥90 days from cancer diagnosis who were receiving acute cancer treatment or follow-up care in oncology clinics. Patients with advanced disease limiting life expectancy to <6 months, acutely suicidal or on antipsychotic medication were excluded. Allowing for attrition due to death or loss to follow-up, the study was powered at the 80% level to detect a 20% difference between study arms in the proportion of patients with ≥50% reduction in PHQ-9 symptoms at 12 months.ResultsOf 2330 patients screened, 23.2% met criteria. An 82.4% enrollment rate resulted in 446 primarily women being recruited and randomized to intervention or usual care.ConclusionThe study applies methods used in primary care depression trials with adaptations for oncology care clinics and for low-income minority patients.