Abstract
BackgroundApproximately 20–30% of patients with cancer experience a clinically relevant level of emotional distress in response to disease and treatment. This in itself is alarming but it is even more problematic because it is often difficult for physicians and nurses to identify cancer patients who experience clinically relevant levels of anxiety and depression symptoms. This can result in persistent distress and can cause human suffering as well as costs for individuals and to the community.MethodsApplying a multi-disciplinary and design-oriented approach aimed at attaining new evidence-based knowledge in basic and applied psychosocial oncology, this protocol will evaluate an intervention to be implemented in clinical practice to reduce cancer patient anxiety and depression. A prospective randomized design will be used.The overarching goal of the intervention is to promote psychosocial health among patients suffering from cancer by means of self-help programmes delivered via an Internet platform. Another goal is to reduce costs for individuals and society, caused by emotional distress in response to cancer.Following screening to detect levels of patient distress, patients will be randomized to standard care or a stepped care intervention. For patients randomized to the intervention, step 1 will consist of self-help material, a chat forum where participants will be able to communicate with each other, and a Frequently Asked Questions (FAQ) section where they can ask questions and get answers from an expert. Patients in the intervention group who still report symptoms of anxiety or depression after access to step 1 will be offered step 2, which will consist of cognitive behavioral therapy (CBT) administered by a personal therapist. The primary end point of the study is patients’ levels of anxiety and depression, evaluated longitudinally during and after the intervention.DiscussionThere is a lack of controlled studies of the psychological and behavioral processes involved in this type of intervention for anxiety and depressive disorders. Since anxiety and depressive symptoms are relatively common in patients with cancer and the availability of adequate support efforts is limited, there is a need to develop evidence-based stepped care for patients with cancer, to be delivered via the Internet.Trial registrationClinicalTrials.gov Identifier: NCT01630681
Highlights
20–30% of patients with cancer experience a clinically relevant level of emotional distress in response to disease and treatment
Most cancer patients have the ability to handle the mental strain that cancer can cause, but a significant proportion of this group report anxiety and depressive symptoms that need to be attended to
A plausible explanation is that only patients with elevated levels of psychological distress are helped by the support
Summary
The present project is part of the Uppsala University psychosocial care programme (U-CARE), an interdisciplinary. Based on experience from previous intervention studies, we estimate that approximately 30% of study participants will not complete the data collection This means that we need to include at least 95 patients in each group. Patients with 7 on any of the HADS subscales) will be randomized to either Internet-based stepped care or standard care. Differences between the intervention and the control group regarding anxiety, depression, post-traumatic stress, healthrelated quality of life and the presence and development of these variables over time will be analysed using analysis of variance (ANOVA) with repeated measurements. All study participants will have an established contact with physicians in routine health care
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