Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Onco-surgery (PERATECS)
This study is ongoing, but not recruiting participants.
Sponsor:
Charite University, Berlin, Germany
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: April 19, 2013
Last verified: April 2013
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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.
| Estimated Enrollment: | 690 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated 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: | April 19, 2013 |
| 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 June 17, 2013