- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631175
Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients
Establishment of an Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients Suffering From Psychosocial Stress
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, 81675
- Department of Orthopedics and Orthopedic Sports Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: (PO-Bado, FBK-R10, PHQ) Active Comparator
|
psychosocial treatment, verbal therapy, relaxation exercises
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0,6,12 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulrich Lenze, MD, Department for Orthopedics and Orthopedic Sports Medicine, Klinikum rechts der Isar der TU München
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Lenze-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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