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.

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
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, see Learn About Clinical Studies.

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 October 19, 2014