Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psychological Distress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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(PO-Bado, FBK-R10, PHQ) Active Comparator

Group Type EXPERIMENTAL

psychosocial treatment

Intervention Type BEHAVIORAL

psychosocial treatment, verbal therapy, relaxation exercises

Interventions

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psychosocial treatment

psychosocial treatment, verbal therapy, relaxation exercises

Intervention Type BEHAVIORAL

Other Intervention Names

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PO-Bado Patient Health Questionaire Questionaire for Psychosocial Burden of Cancer Patients

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No