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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empowerment, shared-decision making,<br>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<br>* Booklet, motivational interviewing, brief advice<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | within the first month | 
| Quality of life |  | within the first year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate |  | within the first three months | 
| Short-term complications |  | within the first months | 
| Overall mortality |  | within one year | 
| Depression |  | within the first year | 
| Stress | Stress induced by postoperative pain, lack of mobilization and PONV. | within the first month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, cancer surgery, quality of life, empowerment, shared-decision