Psychological DistressPhase 3NCT01631175
Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients
A Phase 3 study testing psychosocial treatment in people with Psychological Distress, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress
- What is being tested?
- psychosocial treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age older than 18
- initial diagnosis of a histologically assured sarcoma or metastatic bone disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Orthopedics and Orthopedic Sports Medicine
Munich, Bavaria, 81675
About this study
Official title: Establishment of an Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients Suffering From Psychosocial Stress
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.
Read the 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.
- Conditions
- Psychological Distress
- Being tested
- psychosocial treatment
- Keywords
- sarcoma, distress, tumor, quality of life, cancer
- Medical subject headings
- Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial treatmentBehavioural
Also called PO-Bado, Patient Health Questionaire, Questionaire for Psychosocial Burden of Cancer Patients
psychosocial treatment, verbal therapy, relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| (PO-Bado, FBK-R10, PHQ) Active Comparator | Experimental | Not described Receives: Behavioral: psychosocial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0,6,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Lenze, MD, Principal investigator, Department for Orthopedics and Orthopedic Sports Medicine, Klinikum rechts der Isar der TU München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631175
- Sponsor's protocol ID
- Lenze-2011
- Status last verified
- May 2015
- First submitted
- 20 Jun 2012
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19145091
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of an Indication-based Identification and Psychosocial Treatment of Orthopedic Cancer Patients Suffering From Psychosocial Stress
- ClinicalTrials.gov ID
- NCT01631175
- Acronym / sponsor ID
- Lenze-2011
- Conditions
- Psychological Distress
- Keywords
- sarcoma, distress, tumor, quality of life, cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (PO-Bado, FBK-R10, PHQ) Active Comparator | Experimental | Behavioral: psychosocial treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age older than 18
- initial diagnosis of a histologically assured sarcoma or metastatic bone disease
Key exclusion criteria (7 listed)
- age younger than 18
- benign tumors
- patients with known sarcoma or metastatic bone disease
- patients with known other tumors
- fundamental neurological and psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychosocial treatmentAlso: PO-Bado, Patient Health Questionaire, Questionaire for Psychosocial Burden of Cancer Patientspsychosocial treatment, verbal therapy, relaxation exercises | Behavioural | (PO-Bado, FBK-R10, PHQ) Active Comparator |
Primary outcome
Psychooncological Basic Documentation (PO-BADO)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Background: PubMed 19145091Herschbach 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Lenze, MD principal investigator
Department for Orthopedics and Orthopedic Sports Medicine, Klinikum rechts der Isar der TU München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing psychosocial treatment in people with Psychological Distress, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychooncological Basic Documentation (PO-BADO) (time frame: 0,6,12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.