Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Onco-surgery

Cancer Clinical Trial

— PERATECS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278537
• Other study ID #: PERATECS
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: March 13, 2014
• Start date: February 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Information
Booklet, motivational interviewing, brief advice

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin	Berlin
Germany	Evangelisches Geriatriezentrum Berlin gGmbH	Berlin
Germany	Department of Anaesthesiology, Hospital of the Ludwig - Maximilians - University of Munich	München

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay		within the first month	No
Primary	Quality of life		within the first year	No
Secondary	Readmission rate		within the first three months	No
Secondary	Short-term complications		within the first months	No
Secondary	Overall mortality		within one year	No
Secondary	Depression		within the first year	No
Secondary	Stress	Stress induced by postoperative pain, lack of mobilization and PONV.	within the first month	No