|- candidate number||5976|
|- NTR Number||NTR1868|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jun-2009|
|- Secondary IDs||60-82500-98-8043 ZonMw|
|- Public Title||Stepped care to improve depression and anxiety in cancer patients.|
|- Scientific Title||Cost-effectiveness of a stepped care strategy to improve symptoms of depression or anxiety in patients treated for head and neck cancer or lung cancer.|
|- hypothesis||In the Netherlands over 10.000 patients are diagnosed with head and neck cancer or lung cancer every year of whom 25-50% have comorbid anxiety or depression.
Is a stepped care strategy applied in an oncological setting more (cost-)effective to improve symptoms of anxiety and depression compared with care as usual?
|- Healt Condition(s) or Problem(s) studied||Depression, Anxiety, Head cancer, Lung cancer|
|- Inclusion criteria||1. Treatment for UICC stage I-IV lung or head and neck carcinoma: ICD-10 C00-C14 (lip, oral cavity and pharynx), C32 (larynx), C33 (trachea), C34 (lung); |
2. Depression (minor or major) or (generalized) anxiety disorder as assessed by the Composite International Diagnostic Interview (CIDI).
|- Exclusion criteria||1. Other (neurological) diseases causing cognitive dysfunction;|
2. No motivation to undergo psychosocial therapy;
3. Current treatment for a depressive or anxiety disorder;
4. End of treatment for a psychiatric disorder less than two months ago;
5. High suicide risk;
6. Psychotic and/or manic signs;
7. Too little knowledge of the Dutch language to fill out the questionnaires.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-sep-2013|
|- Target number of participants||176|
|- Interventions||Stepped care model with 4 evidence based steps:|
1. Watchful waiting;
2. Internet-based self-help;
3. Problem Solving Therapy applied by a nurse;
4. Specialised psychological interventions and/or antidepressant medication.
Control group patients receive care as usual.
|- Primary outcome||Primary outcome is the Hospital Anxiety and Depression Scale (HADS). |
|- Secondary outcome||Secondary outcome measures are quality of life questionnaires (EORTC QLQ-C30, EORTC QLQ-HN35, EORTC QLQ-LC13), patient satisfaction with care (EORTC QLQ-PATSAT), and costs (health care utilization and work loss (TIC-P and PRODISQ modules)).
|- Timepoints||0, 3, 6, 9 en 12 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. I.M. Verdonck-de Leeuw|
|- CONTACT for SCIENTIFIC QUERIES||Dr. I.M. Verdonck-de Leeuw|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||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% have 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 demands. A stepped care approach including a web-based self-help intervention has the potential to improve the efficiency of psychosocial care.
Objective of this study is to evaluate cost-effectiveness of a stepped care strategy to improve symptoms of depression or anxiety in patients treated for head and neck cancer or lung cancer.|
|- Main changes (audit trail)|
|- RECORD||18-jun-2009 - 6-okt-2009|