Faculty Collaboration Database

Randomized controlled trial of a collaborative care intervention to manage cancer-related symptoms: lessons learned. Clin Trials 2011 Jun;8(3):298-310

Date

07/07/2011

Pubmed ID

21730078

Pubmed Central ID

PMC3404514

DOI

10.1177/1740774511402368

Scopus ID

2-s2.0-79960236218 (requires institutional sign-in at Scopus site)   19 Citations

Abstract

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.

Author List

Steel J, Geller DA, Tsung A, Marsh JW, Dew MA, Spring M, Grady J, Likumahuwa S, Dunlavy A, Youssef M, Antoni M, Butterfield LH, Schulz R, Day R, Helgeson V, Kim KH, Gamblin TC

Author

Thomas Clark Gamblin MD Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Adult
Carcinoma, Hepatocellular
Cooperative Behavior
Depression
Fatigue
Feasibility Studies
Female
Humans
Liver Neoplasms
Male
Middle Aged
Pain
Patient Care Management
Quality of Life
Research Design
Severity of Illness Index
Young Adult