Clinical trial NCT01278537: Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Onco-surgery
Official title: Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Gastrointestinal, Thoracical or Urogenital Cancer Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: elderly
cancer surgery
quality of life
empowerment
shared-decision
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2011-01-19
Enrollment: 690
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: within the first month
measure: Quality of life
timeFrame: within the first year
Secondary outcomes:
measure: Readmission rate
timeFrame: within the first three months
measure: Short-term complications
timeFrame: within the first months
measure: Overall mortality
timeFrame: within one year
measure: Depression
timeFrame: within the first year
measure: Stress
timeFrame: within the first month
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Evangelisches Geriatriezentrum Berlin gGmbH
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
city: München
country: Germany
facility: Department of Anaesthesiology, Hospital of the Ludwig - Maximilians - University of Munich
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
name: Claudia Spies, MD Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.