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Open Access Study protocol

Stepped care targeting psychological distress in head and neck and lung cancer patients: a randomized clinical trial

Anne-Marie H Krebber1, C René Leemans1, Remco de Bree1, Annemieke van Straten2, Filip Smit67, Egbert F Smit3, Annemarie Becker3, Guus M Eeckhout4, Aartjan TF Beekman4, Pim Cuijpers2 and Irma M Verdonck-de Leeuw125*

Author Affiliations

1 Department of Otolaryngology/Head and Neck Surgery, VU University Medical Center, Amsterdam, the Netherlands

2 Department of Clinical Psychology, VU University, Amsterdam, the Netherlands

3 Department of Pulmonary Diseases, VU University Medical Center, Amsterdam, the Netherlands

4 Department of Psychiatry, VU University Medical Center, Amsterdam, the Netherlands

5 Department of Otolaryngology / Head and Neck Surgery, VU University Medical Center, PO BOX 7057, 1007 MB Amsterdam, The Netherlands

6 Trimbos Institute, Netherlands Institute of Mental Health and Addiction, , Utrecht, The Netherlands

7 Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands

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BMC Cancer 2012, 12:173  doi:10.1186/1471-2407-12-173

Published: 10 May 2012

Abstract

Background

Psychological distress is common in cancer survivors. Although there is some evidence on effectiveness of psychosocial care in distressed cancer patients, referral rate is low. Lack of adequate screening instruments in oncology settings and insufficient availability of traditional models of psychosocial care are the main barriers. A stepped care approach has the potential to improve the efficiency of psychosocial care. The aim of the study described herein is to evaluate efficacy of a stepped care strategy targeting psychological distress in cancer survivors.

Methods/design

The study is designed as a randomized clinical trial with 2 treatment arms: a stepped care intervention programme versus care as usual. Patients treated for head and neck cancer (HNC) or lung cancer (LC) are screened for distress using OncoQuest, a computerized touchscreen system. After stratification for tumour (HNC vs. LC) and stage (stage I/II vs. III/IV), 176 distressed patients are randomly assigned to the intervention or control group. Patients in the intervention group will follow a stepped care model with 4 evidence based steps: 1. Watchful waiting, 2. Guided self-help via Internet or a booklet, 3. Problem Solving Treatment administered by a specialized nurse, and 4. Specialized psychological intervention or antidepressant medication. In the control group, patients receive care as usual which most often is a single interview or referral to specialized intervention. Primary outcome is the Hospital Anxiety and Depression Scale (HADS). Secondary outcome measures are a clinical level of depression or anxiety (CIDI), quality of life (EQ-5D, EORTC QLQ-C30, QLQ-HN35, QLQ-LC13), patient satisfaction with care (EORTC QLQ-PATSAT), and costs (health care utilization and work loss (TIC-P and PRODISQ modules)). Outcomes are evaluated before and after intervention and at 3, 6, 9 and 12 months after intervention.

Discussion

Stepped care is a system of delivering and monitoring treatments, such that effective, yet least resource-intensive, treatment is delivered to patients first. The main aim of a stepped care approach is to simplify the patient pathway, provide access to more patients and to improve patient well-being and cost reduction by directing, where appropriate, patients to low cost (self-)management before high cost specialist services.

Trial registration

NTR1868

Keywords:
Cancer; Distress; Anxiety; Depression; Psychosocial care; Stepped care; Screening; Quality of life; Efficacy