Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Onco-surgery
PERATECS
1 other identifier
interventional
690
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Feb 2011
Typical duration for not_applicable cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2011
CompletedFirst Posted
Study publicly available on registry
January 19, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 14, 2014
March 1, 2014
2.9 years
January 18, 2011
March 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Length of hospital stay
within the first month
Quality of life
within the first year
Secondary Outcomes (5)
Readmission rate
within the first three months
Short-term complications
within the first months
Overall mortality
within one year
Depression
within the first year
Stress
within the first month
Study Arms (2)
Empowerment, shared-decision making,
EXPERIMENTALPatients receive a booklet with informations. Assessment of health-related risk factors. Assessment of psychological and physical social support Delirium protection. Early mobilization.
control group
NO INTERVENTIONInterventions
Booklet, motivational interviewing, brief advice
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Anaesthesiology, Hospital of the Ludwig - Maximilians - University of Munich
München, München, 81377, Germany
Evangelisches Geriatriezentrum Berlin gGmbH
Berlin, State of Berlin, 13347, Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, 13353, Germany
Related Publications (4)
Scholtz K, Borchers F, Morgeli R, Krampe H, Schmidt M, Eckardt-Felmberg R, von Dossow V, Sehouli J, Stief CG, Pohrt A, Spies CD; PERATECS Group. Self-reported exhaustion and a 4-item physical frailty index to predict the incidence of major complications after onco-geriatric surgery. Eur J Surg Oncol. 2024 Jul;50(7):108421. doi: 10.1016/j.ejso.2024.108421. Epub 2024 May 23.
PMID: 38870573DERIVEDMueller 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.
PMID: 31668693DERIVEDScholtz 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.
PMID: 29359461DERIVEDSchmidt 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.
PMID: 26378939DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Claudia Spies, MD Prof.
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ. Prof. Dr. med. Claudia Spies
Study Record Dates
First Submitted
January 18, 2011
First Posted
January 19, 2011
Study Start
February 1, 2011
Primary Completion
January 1, 2014
Study Completion
February 1, 2014
Last Updated
March 14, 2014
Record last verified: 2014-03