Randomized controlled trial of a collaborative care intervention to manage cancer-related symptoms: lessons learned
Authors: Steel Jennifer , Geller David A , Tsung Allan , Marsh J Wallis , Dew Mary Amanda , Spring Michael , Grady Jonathan , Likumahuwa Sonja , Dunlavy Andrea , Youssef Michael , Antoni Michael , Butterfield Lisa H , Schulz Richard , Day Richard , Helgeson Vicki , Kim Kevin H , Gamblin T Clark 
Published: July 2011

Background Collaborative care interventions to treat depression have begun to be tested in settings outside of primary care. However, few studies have expanded the collaborative care model to other settings and targeted comorbid physical symptoms of depression.

Purpose The aims of this report were to: (1) describe the design and methods of a trial testing the efficacy of a stepped collaborative care intervention designed to manage cancer-related symptoms and improve overall quality of life in patients diagnosed with hepatobiliary carcinoma; and (2) share the lessons learned during the design, implementation, and evaluation of the trial.

Methods The trial was a phase III randomized controlled trial testing the efficacy of a stepped collaborative care intervention to reduce depression, pain, and fatigue in patients diagnosed with advanced cancer. The intervention was compared to an enhanced usual care arm. The primary outcomes included the Center for Epidemiological Studies-Depression scale, Brief Pain Inventory, and Functional Assessment of Cancer Therapy (FACT)-Fatigue, and the FACT-Hepatobiliary. Sociodemographic and disease-specific characteristics were recorded from the medical record; Natural Killer cells and cytokines that are associated with these symptoms and with disease progression were assayed from serum.

Results  and  Discussion The issues addressed include: (1) development of collaborative care in the context of oncology (e.g., timing of the intervention, tailoring of the intervention, ethical issues regarding randomization of patients, and changes in medical treatment over the course of the study); (2) use of a website by chronically ill populations (e.g., design and access to the website, development of the website and intervention, ethical issues associated with website development, website usage, and unanticipated costs associated with website development); (3) evaluation of the efficacy of intervention (e.g., patient preferences, proxy raters, changes in medical treatment, and inclusion of biomarkers as endpoints); and (4) analyses and interpretation of the intervention (e.g., confounding factors, dose and active ingredients, and risks and benefits of collaborative care interventions in chronically ill patients).

Limitations The limitations to the study, although not fully realized at this time as the trial is ongoing, include: (1) heterogeneity of the diagnoses and treatments of participants; and (2) inclusion of caregivers as proxy raters but not as participants in the intervention.

Conclusions Collaborative care interventions to manage multiple symptoms in a tertiary cancer center are feasible. However, researchers designing and implementing interventions that are web-based, target multiple symptoms, and for oncology patients may benefit from previous experiences.