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

This study has been completed.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01278537
First received: January 18, 2011
Last updated: March 13, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: within the first month ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: within the first year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Readmission rate [ Time Frame: within the first three months ] [ Designated as safety issue: No ]
  • Short-term complications [ Time Frame: within the first months ] [ Designated as safety issue: No ]
  • Overall mortality [ Time Frame: within one year ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: within the first year ] [ Designated as safety issue: No ]
  • Stress [ Time Frame: within the first month ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278537

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, Germany, 13353
Evangelisches Geriatriezentrum Berlin gGmbH
Berlin, Germany, 13347
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

No publications provided

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
Study First Received: January 18, 2011
Last Updated: March 13, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 23, 2014