- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278537
Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Onco-surgery (PERATECS)
March 13, 2014 updated by: Claudia Spies, Charite University, Berlin, Germany
Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Gastrointestinal, Thoracical or Urogenital Cancer Surgery.
The aims of this study are to investigate whether patient empowerment, including information and decision-aids adapted to the risk and the need of the elderly patient, can improve outcome in an evidence-based modular pathway in terms of
- shortened hospital stay by a reduced postoperative complication rate and
- quality of life in elderly patients compared to control patients receiving standard of care.
Study Overview
Study Type
Interventional
Enrollment (Actual)
690
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
-
Berlin, Germany, 13347
- Evangelisches Geriatriezentrum Berlin gGmbH
-
München, Germany, 81377
- Department of Anaesthesiology, Hospital of the Ludwig - Maximilians - University of Munich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 65 years and older with abdominal, thoracical or urogenital cancer scheduled for surgery
- Offered patient information and written informed consent
- Confirmed cancer diagnosis via histology
- Mini Mental state > 23
- Life-expectance > 2 months
Exclusion Criteria:
- Participation in another trial according to the German Drug Law 7 days to and 7 days after the operation during the study
- No informed consent
- Emergency patients
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- Concurrent malignancies
- Insufficient knowledge of the German language
- In case of the inclusion of a PERATECS - study patient in an adjuvant therapy study during the study period, the patient will be excluded from the PERATECS-study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: Empowerment, shared-decision making,
Patients receive a booklet with informations.
Assessment of health-related risk factors.
Assessment of psychological and physical social support Delirium protection.
Early mobilization.
|
Booklet, motivational interviewing, brief advice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: within the first month
|
within the first month
|
Quality of life
Time Frame: within the first year
|
within the first year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission rate
Time Frame: within the first three months
|
within the first three months
|
|
Short-term complications
Time Frame: within the first months
|
within the first months
|
|
Overall mortality
Time Frame: within one year
|
within one year
|
|
Depression
Time Frame: within the first year
|
within the first year
|
|
Stress
Time Frame: within the first month
|
Stress induced by postoperative pain, lack of mobilization and PONV.
|
within the first month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Claudia Spies, MD Prof., Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mueller A, Spies CD, Eckardt R, Weiss B, Pohrt A, Wernecke KD, Schmidt M; PERATECS-Group. Anticholinergic burden of long-term medication is an independent risk factor for the development of postoperative delirium: A clinical trial. J Clin Anesth. 2020 May;61:109632. doi: 10.1016/j.jclinane.2019.109632. Epub 2019 Oct 24.
- Scholtz K, Spies CD, Morgeli R, Eckardt R, von Dossow V, Braun S, Sehouli J, Bahra M, Stief CG, Wernecke KD, Schmidt M; PERATECS Group. Risk factors for 30-day complications after cancer surgery in geriatric patients: a secondary analysis. Acta Anaesthesiol Scand. 2018 Apr;62(4):451-463. doi: 10.1111/aas.13067. Epub 2018 Jan 22.
- Schmidt M, Eckardt R, Scholtz K, Neuner B, von Dossow-Hanfstingl V, Sehouli J, Stief CG, Wernecke KD, Spies CD; PERATECS Group. Patient Empowerment Improved Perioperative Quality of Care in Cancer Patients Aged >/= 65 Years - A Randomized Controlled Trial. PLoS One. 2015 Sep 17;10(9):e0137824. doi: 10.1371/journal.pone.0137824. eCollection 2015.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (Estimate)
January 19, 2011
Study Record Updates
Last Update Posted (Estimate)
March 14, 2014
Last Update Submitted That Met QC Criteria
March 13, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- PERATECS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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