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Stepped care to improve symptoms of anxiety and depression in cancer patients


In the Netherlands over 10.000 patients are diagnosed with lung cancer (LC) or head and neck cancer (HNC) every year of whom 25-50% has comorbid anxiety or depression after treatment. Although there is evidence on efficacy of psychosocial cancer care in general, patients with poor survival rates (LC) or less prevalent tumours (HNC) are often not involved, while these patients are among the most distressed patients. Barriers to admission to psychosocial care are a lack of adequate screening instruments in oncology settings, and that traditional models of the delivery of psychosocial care do not meet current demand. A stepped care approach including a web-based self-help intervention has the potential to improve the efficiency of psychosocial care.

The main goal is to assess cost-effectiveness of a stepped care strategy applied in an oncological setting compared to care as usual in patients treated for LC or HNC to improve symptoms of anxiety or depression. Stepped care is a psychosocial program consisting of 4 evidence based steps: 1. Watchful waiting, 2. Internet-based self-help, 3. Problem Solving Therapy applied by a nurse, and 4. Specialised psychological interventions and/or antidepressant medication.
This study will also provide insight in possible determinants of anxiety and depression and efficacy of intervention in cancer patients such as age, gender, co-morbidity, cancer treatment modality, prognosis, and treatment-related side effects as pain, fatigue, and respiratory, speech or swallowing impairment. Furthermore, this study on a selected group of LC and HNC cancer patients can serve as a baseline for studies on other cancer sites.

Study design: A prospective randomised controlled trial in two parallel groups of the stepped care intervention versus care as usual. In order to assess efficacy, assessment before and after intervention will take place and at 3, 6, 9, and 12 months follow up. These intervals relate closely to the interventions and to routine oncological follow up visits.
Study population:  Patients 1-36 months after treatment for LC or HNC cancer at the VU University Medical Center with DSM-IV diagnoses of depression (minor or major) or generalized anxiety disorder as measured with the Composite International Diagnostic Interview (CIDI). Exclusion criteria are other (neurological) diseases causing cognitive dysfunction, no motivation to undergo psychosocial therapy, current treatment for a depressive or anxiety disorder, end of treatment for a psychiatric disorder less than two months ago, high suicide risk, psychotic and/or manic signs, too little knowledge of the Dutch language to fill out the questionnaires.
Intervention: Stepped care psychosocial program. Control group patients receive care as usual which most often is no intervention or referral to specialised intervention.
Sample size calculation: To demonstrate an effect size of 0.50, 88 patients are needed in each group (power 80%, significance level 5%).
Instruments: Primary outcome is the Hospital Anxiety and Depression Scale (HADS). Secondary outcome measures are quality of life questionnaires (EORTC QLQ-C30, EORTC QLQ-HN35, EORTC QLQ-LC13), patient satisfaction with care (EORTC QLQ-PATSAT), positive outcomes of trauma (PTGI), locus of control (Mastery Scale) and costs (health care utilization and work loss (TIC-P and PRODISQ modules)).
Statistical analysis: Repeated ANOVA will be used to determine efficacy of intervention. Longitudinal changes over time will also be evaluated using GEE-analyses. A cost-utility analysis will be performed for (changes) in quality of life (EQ-5D).

Permission METC
This project is approved by the Medical Ethical Committee VU University Medical Center (VUmc)

ZonMw and Fonds NutsOhra

A.M.H. Krebber, PhD MD, VUmc.
Prof I.M. Verdonck-de Leeuw, PhD, Psychologist, Speech and Language Therapist, Linguist, Vdpt. of Otolaryngology-Head & Neck Surgery, VUmc and dpt. of Clinical Psychology, VU Faculty of Psychology and Education.
Prof C.R. Leemans, PhD MD, Head & Neck Surgeon, ENT-specialist, dpt. of Otolaryngology-Head & Neck Surgery, VUmc.

For questions, please contact:
prof dr IM Verdonck-de Leeuw
Email: s.biemans@vumc.nl

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Team work

Our research projects are embedded in the two largest research institutes of VU University in Amsterdam: VUmc CCA-VICI (Cancer Center Amsterdam) www.vumc.nl/afdelingen/CCA-V-ICI/ and EMGO+ (Institute for Health and Care Research emgo.nl

We work closely with patients and their caregivers and with researchers and physicians at VU University and VU University Medical Center in Amsterdam and other research institutes and hospitals in the Netherlands and worldwide. Team work is crucial  improving research and translating results into clinical practice.

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