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Establishment of an Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients Suffering From Psychosocial Stress

Phase 3
18 Years
Open (Enrolling)
Psychological Distress

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Trial Information

Establishment of an Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients Suffering From Psychosocial Stress

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.

Inclusion Criteria:

- age older than 18

- initial diagnosis of a histologically assured sarcoma or metastatic bone disease

Exclusion Criteria:

- age younger than 18

- benign tumors

- patients with known sarcoma or metastatic bone disease

- patients with known other tumors

- fundamental neurological and psychiatric disorders

- prisoners

- patients with guardianship

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Psychooncological Basic Documentation (PO-BADO)

Outcome Description:

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.

Outcome Time Frame:

0,6,12 month

Safety Issue:


Principal Investigator

Ulrich Lenze, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department for Orthopedics and Orthopedic Sports Medicine, Klinikum rechts der Isar der TU M√ľnchen


Germany: Ethics Commission

Study ID:




Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Psychological Distress
  • sarcoma
  • distress
  • tumor
  • quality of life
  • cancer