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

ABSTRACT

OBJECTIVE: This 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. METHODS: The 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 > or =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. RESULTS: Of 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. CONCLUSION: The study applies methods used in primary care depression trials with adaptations for oncology care clinics and for low-income minority patients.