Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients

Phase 3

Completed

• Conditions: Psychological Distress
• Interventions: Behavioral: psychosocial treatment

• Registration Number: NCT01631175
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(PO-Bado, FBK-R10, PHQ) Active Comparator	psychosocial treatment	-

Primary Outcome Measures

Name	Time	Method
Psychooncological Basic Documentation (PO-BADO)	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.

Trial Locations

Locations (1)

Department of Orthopedics and Orthopedic Sports Medicine; 🇩🇪 Munich, Bavaria, Germany