NCT01278537
Completed
Not Applicable
Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Gastrointestinal, Thoracical or Urogenital Cancer Surgery.
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.
Investigators
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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