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

Charité University Medicine Berlin

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Information

Study type: Interventional

Funder types: Other

Identifiers

NCT01278537

PERATECS

Details and patient eligibility

About

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.

Enrollment: 690 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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690 participants in 2 patient groups

Empowerment, shared-decision making,

Experimental group

Description:

Patients receive a booklet with informations. Assessment of health-related risk factors. Assessment of psychological and physical social support Delirium protection. Early mobilization.

Treatment:

Behavioral: Information

control group

No Intervention group