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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278537
First Posted: January 19, 2011
Last Update Posted: March 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
  Purpose

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.

Condition Intervention
Cancer Behavioral: Information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Gastrointestinal, Thoracical or Urogenital Cancer Surgery.

Further study details as provided by Claudia Spies, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: within the first month ]
  • Quality of life [ Time Frame: within the first year ]

Secondary Outcome Measures:
  • Readmission rate [ Time Frame: within the first three months ]
  • Short-term complications [ Time Frame: within the first months ]
  • Overall mortality [ Time Frame: within one year ]
  • Depression [ Time Frame: within the first year ]
  • Stress [ Time Frame: within the first month ]
    Stress induced by postoperative pain, lack of mobilization and PONV.


Enrollment: 690
Study Start Date: February 2011
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Empowerment, shared-decision making,
Patients receive a booklet with informations. Assessment of health-related risk factors. Assessment of psychological and physical social support Delirium protection. Early mobilization.
Behavioral: Information
Booklet, motivational interviewing, brief advice
No Intervention: control group

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278537


Locations
Germany
Evangelisches Geriatriezentrum Berlin gGmbH
Berlin, Germany, 13347
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, Germany, 13353
Department of Anaesthesiology, Hospital of the Ludwig - Maximilians - University of Munich
München, Germany, 81377
Sponsors and Collaborators
Charite University, Berlin, Germany
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Study Chair: Claudia Spies, MD Prof. Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Claudia Spies, Univ. Prof. Dr. med. Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01278537     History of Changes
Other Study ID Numbers: PERATECS
First Submitted: January 18, 2011
First Posted: January 19, 2011
Last Update Posted: March 14, 2014
Last Verified: March 2014

Keywords provided by Claudia Spies, Charite University, Berlin, Germany:
elderly
cancer surgery
quality of life
empowerment
shared-decision