Clinical trial · Interventional
Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Onco-surgery
Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Gastrointestinal, Thoracical or Urogenital Cancer Surgery.
NCT01278537CI-TRIAL-00014029PERATECScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Information | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Empowerment, shared-decision making,
- description
- Patients receive a booklet with informations. Assessment of health-related risk factors. Assessment of psychological and physical social support Delirium protection. Early mobilization.
- interventionNames
- Behavioral: Information
- type
- NO_INTERVENTION
- label
- control group
Primary outcomes (2)
- measure
- Length of hospital stay
- timeFrame
- within the first month
- measure
- Quality of life
- timeFrame
- within the first year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDScholtz 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. PMID 38870573
- DERIVEDMueller 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. PMID 31668693
- DERIVEDScholtz 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. PMID 29359461
- DERIVEDSchmidt 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. PMID 26378939