Abstract
BackgroundPsychological 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/designThe 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.DiscussionStepped 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 registrationNTR1868
Highlights
Psychological distress is common in cancer survivors
Because of the overwhelming evidence of psychological distress in lung cancer (LC) and head and neck cancer (HNC) patients, intervention is recommended in national guidelines
Design In this prospective randomized controlled trial in two parallel groups, patients are recruited by screening all LC and HNC patients, who visit the Department of Pulmonary Diseases or the Department of Otolaryngology and Head and Neck Surgery of the VU University Medical Center in Amsterdam, the Netherlands, for followup consultation at least one month after treatment, for distress using a computerized touch screen data collection system (OncoQuest) or by telephone using the Hospital Anxiety and Depression Scale (HADS)
Summary
There is a rising need towards screening for physical and psychosocial problems and the need for supportive care in routine clinical practice through patient-reported outcomes (PRO’s) [50,51,52,53,54]. From an economic perspective and in an age of increasing numbers of cancer survivors and increasing shortages of health care personnel, it is relevant to integrate costeffective health care options including e-health applications into a stepped care approach, as in the presented RCT This fits right in with the importance that patient organizations, policy makers and researchers currently attach to e-health self-management tools. In case of positive results of this RCT on effectiveness, a second step aims at adaptation and maintenance of the stepped care approach to bring the evidence-based practice regarding improving distress in cancer patients into consistent and appropriate use in all oncological centers in the Netherlands.
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