Screening and treatment of psychological distress in patients with metastatic colorectal cancer: study protocol of the TES trial.

Claudia Sew Schuurhuizen,Aartjan Tf Beekman,Joost Dekker,Mecheline Hm Van Der Linden,Hanna Bomhof-Roordink,Pim Cuijpers,Inge Rhm Konings,Henk Mw Verheul,Annemarie Mj Braamse,Adriaan W Hoogendoorn,Judith E Bosmans,Elisabeth Cw Neefjes

doi:10.1186/s12885-015-1313-y

Claudia Sew Schuurhuizen, Aartjan Tf Beekman + Show 10 more

Open Access

https://doi.org/10.1186/s12885-015-1313-y

Copy DOI

Abstract

Background/IntroductionPsychological distress occurs frequently in patients with cancer. Psychological distress includes mild and severe forms of both anxious and depressive mood states. Literature indicates that effective management of psychological distress seems to require targeted selection of patients (T), followed by enhanced care (E), and the application of evidence based interventions. Besides, it is hypothesized that delivering care according to the stepped care (S) approach results in an affordable program. The aim of the current study is to evaluate the (cost)-effectiveness of the TES program compared to usual care in reducing psychological distress in patients with metastatic colorectal cancer (mCRC).MethodsThis study is designed as a cluster randomized trial with 2 treatment arms: TES program for screening and treatment of psychological distress versus usual care. Sixteen hospitals participate in this study, recruiting patients with mCRC. Outcomes are evaluated at the beginning of chemotherapy and after 3, 10, 24, and 48 weeks. Primary outcome is the difference in treatment effect over time in psychological distress, assessed with the Hospital Anxiety and Depression Scale. Secondary outcomes include quality of life, patient evaluation of care, recognition and management of psychological distress, and societal costs.DiscussionWe created optimal conditions for an effective screening and treatment program for psychological distress in patients with mCRC. This involves targeted selection of patients, followed by enhanced and stepped care. Our approach will be thoroughly evaluated in this study. We expect that our results will contribute to the continuing debate on the (cost-) effectiveness of screening for and treatment of psychological distress in patients with cancer.Trial RegistrationThis trial is registered in the Netherlands Trial Register NTR4034

Highlights

Colorectal cancer (CRC) is one of the most prevalent cancers and causes of cancer-related mortality in developed countries [1], with over 1.3 million new cancer cases and 694,000 deaths estimated to have occurred in 2012 worldwide in 2012 [2]
We expect that our results will contribute to the continuing debate on the effectiveness of screening for and treatment of psychological distress in patients with cancer
With the current study, we aim to evaluate the effectiveness of the Targeted Selection (TES) program, using screening, enhanced care and a multi-disciplinary and stepped care oriented approach in which well-described effective psychotherapeutic and pharmacotherapeutic interventions are implemented, compared to usual care in reducing psychological distress in patients with metastatic colorectal cancer (mCRC)

Summary

Introduction

Colorectal cancer (CRC) is one of the most prevalent cancers and causes of cancer-related mortality in developed countries [1], with over 1.3 million new cancer cases and 694,000 deaths estimated to have occurred in 2012 worldwide in 2012 [2]. Precise estimates vary with different types and sites of cancer, approximately 30-40% of patients receiving cancer care experience psychological symptoms of distress, such as depression and anxiety [5,6]. These findings apply to patients with CRC: a large proportion of patients seems to suffer from psychological morbidity [5,7]; the presence of metastases is associated with even more psychological symptoms [8,9]

Objectives

Methods

Findings

Conclusion