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

NCT ID: NCT01278537

Last Updated: 2014-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-02-28

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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Information

Intervention Type BEHAVIORAL

Booklet, motivational interviewing, brief advice

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Information

Booklet, motivational interviewing, brief advice

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia Spies

Univ. Prof. Dr. med. Claudia Spies

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Spies, MD Prof.

Role: STUDY_CHAIR

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin

Locations

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Department of Anaesthesiology, Hospital of the Ludwig - Maximilians - University of Munich

München, München, Germany

Site Status

Evangelisches Geriatriezentrum Berlin gGmbH

Berlin, State of Berlin, Germany

Site Status

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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Scholtz K, Borchers F, Morgeli R, Krampe H, Schmidt M, Eckardt-Felmberg R, von Dossow V, Sehouli J, Stief CG, Pohrt A, Spies CD; PERATECS Group. Self-reported exhaustion and a 4-item physical frailty index to predict the incidence of major complications after onco-geriatric surgery. Eur J Surg Oncol. 2024 Jul;50(7):108421. doi: 10.1016/j.ejso.2024.108421. Epub 2024 May 23.

Reference Type DERIVED
PMID: 38870573 (View on PubMed)

Mueller A, Spies CD, Eckardt R, Weiss B, Pohrt A, Wernecke KD, Schmidt M; PERATECS-Group. Anticholinergic burden of long-term medication is an independent risk factor for the development of postoperative delirium: A clinical trial. J Clin Anesth. 2020 May;61:109632. doi: 10.1016/j.jclinane.2019.109632. Epub 2019 Oct 24.

Reference Type DERIVED
PMID: 31668693 (View on PubMed)

Scholtz K, Spies CD, Morgeli R, Eckardt R, von Dossow V, Braun S, Sehouli J, Bahra M, Stief CG, Wernecke KD, Schmidt M; PERATECS Group. Risk factors for 30-day complications after cancer surgery in geriatric patients: a secondary analysis. Acta Anaesthesiol Scand. 2018 Apr;62(4):451-463. doi: 10.1111/aas.13067. Epub 2018 Jan 22.

Reference Type DERIVED
PMID: 29359461 (View on PubMed)

Schmidt M, Eckardt R, Scholtz K, Neuner B, von Dossow-Hanfstingl V, Sehouli J, Stief CG, Wernecke KD, Spies CD; PERATECS Group. Patient Empowerment Improved Perioperative Quality of Care in Cancer Patients Aged >/= 65 Years - A Randomized Controlled Trial. PLoS One. 2015 Sep 17;10(9):e0137824. doi: 10.1371/journal.pone.0137824. eCollection 2015.

Reference Type DERIVED
PMID: 26378939 (View on PubMed)

Other Identifiers

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PERATECS

Identifier Type: -

Identifier Source: org_study_id

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