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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 20, 2012
CompletedFirst Posted
Study publicly available on registry
June 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 14, 2015
May 1, 2015
2.9 years
June 20, 2012
May 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychooncological Basic Documentation (PO-BADO)
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
Study Arms (1)
(PO-Bado, FBK-R10, PHQ) Active Comparator
EXPERIMENTALInterventions
psychosocial treatment, verbal therapy, relaxation exercises
Eligibility Criteria
You may qualify if:
- age older than 18
- initial diagnosis of a histologically assured sarcoma or metastatic bone disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopedics and Orthopedic Sports Medicine
Munich, Bavaria, 81675, Germany
Related Publications (1)
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.
PMID: 19145091BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrich Lenze, MD
Department for Orthopedics and Orthopedic Sports Medicine, Klinikum rechts der Isar der TU München
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2012
First Posted
June 29, 2012
Study Start
January 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 14, 2015
Record last verified: 2015-05