Randomized Control Trial to Test a Computerized Psychosocial Cancer Assessment and Referral Program: Methods and Research Design

The National Cancer Coalition Network, National Cancer Institute, and American College of Surgeons all emphasize the need for oncology providers to identify, address, and monitor psychosocial needs of their patients. The Mental Health Assessment and Dynamic Referral for Oncology (MHADRO) is a patient-driven, computerized, psychosocial assessment that identifies, addresses, and monitors physical, psychological, and social issues faced by oncology patients. This paper presents the methodology of a randomized controlled trial (RCT) that tested the impact of the MHADRO on patient outcomes at 2, 6, and 12 months. Patient outcomes including overall psychological distress, depression, anxiety, functional disability, and use of psychosocial resources will be presented in future publications after all follow–up data is gathered. Eight hundred and thirty six cancer patients with heterogeneous diagnoses, across three comprehensive cancer centers in different parts of the United States, were randomized to the MHADRO (intervention) or an assessment-only control group. Patients in the intervention group were provided detailed, personalized reports and, when needed, referrals to mental health services; their oncology provider received detailed reports designed to foster clinical decision making. Those patients who demonstrated high levels of psychosocial problems were given the option to authorize that a copy of their report be sent electronically to a “best match” mental health professional. Demographic and patient cancer-related data as well as comparisons between patients who were enrolled and those who declined enrollment are presented. Challenges encountered during the RCT and strategies used to address them are discussed. *Corresponding author at: Department of Psychology, Stonehill College, 320 Washington Street, Easton, MA 02357 United States. Tel.: +1 508 340 0517. acutillo@students.stonehill.edu. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Public Access Author Manuscript Contemp Clin Trials. Author manuscript; available in PMC 2014 May 01. Published in final edited form as: Contemp Clin Trials. 2013 May ; 35(1): 15–24. doi:10.1016/j.cct.2013.02.001. N IH PA Athor M anscript N IH PA Athor M anscript N IH PA Athor M anscript