Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01631175|
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : May 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Psychological Distress||Behavioral: psychosocial treatment||Phase 3|
Aim of this study is to develop and establish an indication-based algorithm for identifying particular stress patterns of patients with initial diagnosis of a sarcoma or a metastatic bone disease. A further aim was the establishment of an adequate psychosocial treatment within the clinical workday routine to support coping with illness and treatment.
Patients with histologically assured sarcoma or metastatic bone disease are psycho-oncologically screened by a common cancer specific expert rating scale (PO-Bado: Basic Documentation for Psycho-Oncology, 6 items) at the time of admission before tumor resection. In the same line patients were asked to answer two standardized self-rating questionaires, namely the FBK-R10 (Questionaire for Psychosocial Burden of Cancer Patients, 10 items) and a modified form of the PHQ (Patient Health Questionaire, 2 items) to assess patients' burden of disease as well as the presence of depressive mood. Cancer patients exceeding a defined critical PO-Bado cut-off value (a minimum of 2 items scoring 3 or 1 item scoring 4) are expected to require psychosocial support and a psychosocial consultation/co-treatment iss initiated.
To evaluate short-term effects of the psycho-social treatment the cancer-specific screening is repeated (PO-Bado, FBK-R10, PHQ) before discharge from the hospital. All diagnostic findings as well as a specific recommendation for the continuing treatment are integrated into the orthopedic discharge letter. Furthermore, all findings are shown and factored for decision making within the interdisciplinary musculoskeletal tumor board. For appraisal of treatment-based long-term effects the psycho-oncological screening is repeated within the orthopedic aftercare examinations 3 and 6 months postoperatively.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Establishment of an Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients Suffering From Psychosocial Stress|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|Experimental: (PO-Bado, FBK-R10, PHQ) Active Comparator||
Behavioral: psychosocial treatment
psychosocial treatment, verbal therapy, relaxation exercises
- Psychooncological Basic Documentation (PO-BADO) [ Time Frame: 0,6,12 month ]The PO-BADO is a cancer-specific screening instrument. It enables clinical staff to screen cancer patients for the need of psycho-oncological support as well as to document and assess psychosocial stress. The PO-Bado has been psychometrically evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631175
|Department of Orthopedics and Orthopedic Sports Medicine|
|Munich, Bavaria, Germany, 81675|
|Principal Investigator:||Ulrich Lenze, MD||Department for Orthopedics and Orthopedic Sports Medicine, Klinikum rechts der Isar der TU München|