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Clinical Trials/NCT01278537
NCT01278537
Completed
Not Applicable

Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Gastrointestinal, Thoracical or Urogenital Cancer Surgery.

Charite University, Berlin, Germany3 sites in 1 country690 target enrollmentFebruary 2011
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Charite University, Berlin, Germany
Enrollment
690
Locations
3
Primary Endpoint
Length of hospital stay
Status
Completed
Last Updated
12 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
February 2011
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudia Spies

Univ. Prof. Dr. med. Claudia Spies

Charite University, Berlin, Germany

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

Outcomes

Primary Outcomes

Length of hospital stay

Time Frame: within the first month

Quality of life

Time Frame: within the first year

Secondary Outcomes

  • 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 Sites (3)

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