Clinical trial NCT01631175: Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients
Official title: Establishment of an Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients Suffering From Psychosocial Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psychological Distress
Keywords: sarcoma
distress
tumor
quality of life
cancer
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Methods:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychooncological Basic Documentation (PO-BADO)
timeFrame: 0,6,12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Orthopedics and Orthopedic Sports Medicine
state: Bavaria
Study officials:
affiliation: Department for Orthopedics and Orthopedic Sports Medicine, Klinikum rechts der Isar der TU München
name: Ulrich Lenze, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herschbach P, Book K, Brandl T, Keller M, Marten-Mittag B. The Basic Documentation for Psycho-Oncology (PO-Bado): an expert rating scale for the psychosocial experience of cancer patients. Onkologie. 2008 Nov;31(11):591-6. doi: 10.1159/000162287. Epub 2008 Oct 27.