Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Technische Universität München.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01631175
First received: June 20, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Psychological Distress
Behavioral: psychosocial treatment
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Psychooncological Basic Documentation (PO-BADO) [ Time Frame: 0,6,12 month ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (PO-Bado, FBK-R10, PHQ) Active Comparator Behavioral: psychosocial treatment
psychosocial treatment, verbal therapy, relaxation exercises
Other Names:
  • PO-Bado
  • Patient Health Questionaire
  • Questionaire for Psychosocial Burden of Cancer Patients

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631175

Locations
Germany
Department of Orthopedics and Orthopedic Sports Medicine Recruiting
Munich, Bavaria, Germany, 81675
Contact: Ulrich Lenze, MD    00491794571148    Uli_Lenze@web.de   
Sub-Investigator: Peter Herschbach, Prof. Dr.         
Sub-Investigator: Chlodwig Kirchhoff, PD Dr.         
Sub-Investigator: Ruediger von Eisenhart-Rothe, Prof. Dr.         
Sub-Investigator: Katrin Book, Dr.         
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Ulrich Lenze, MD Department for Orthopedics and Orthopedic Sports Medicine, Klinikum rechts der Isar der TU München
  More Information

Publications:
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01631175     History of Changes
Other Study ID Numbers: Lenze-2011
Study First Received: June 20, 2012
Last Updated: June 28, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
sarcoma
distress
tumor
quality of life
cancer

ClinicalTrials.gov processed this record on September 30, 2014