Ignite Creation Date:
2024-05-06 @ 12:41 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01631175
Status:
COMPLETED
Last Update Posted:
2015-05-14
First Post:
2012-06-20
Brief Title:
Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Establishment of an Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients Suffering From Psychosocial Stress
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 consultationco-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
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 consultationco-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None