CancerPERATECSNCT01278537
Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Onco-surgery
A study testing Information in people with Cancer, run by Charite University, Berlin, Germany at 3 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Germany3 sites
Evangelisches Geriatriezentrum Berlin gGmbH
Berlin, State of Berlin, 13347
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, 13353
Department of Anaesthesiology, Hospital of the Ludwig - Maximilians - University of Munich
München, München, 81377
About this study
Official title: Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Gastrointestinal, Thoracical or Urogenital Cancer Surgery.
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
- Cancer
- Being tested
- Information
- Keywords
- elderly, cancer surgery, quality of life, empowerment, shared-decision
- Medical subject headings
- Neoplasms, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformationBehavioural
Booklet, motivational interviewing, brief advice
| Study group | Role | What they receive |
|---|---|---|
| Empowerment, shared-decision making, | Experimental | Patients receive a booklet with informations. Assessment of health-related risk factors. Assessment of psychological and physical social support Delirium protection. Early mobilization. Receives: Behavioral: Information |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: within the first month
Quality of life
Measured: within the first year
Secondary outcomes (5)
Readmission rate
Measured: within the first three months
Short-term complications
Measured: within the first months
Overall mortality
Measured: within one year
Depression
Measured: within the first year
Stress
Stress induced by postoperative pain, lack of mobilization and PONV.
Measured: within the first month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD Prof., Study chair, Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278537
- Sponsor's protocol ID
- PERATECS
- Acronym
- PERATECS
- Status last verified
- Mar 2014
- First submitted
- 18 Jan 2011
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38870573Mueller 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.
PubMed 31668693Scholtz 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.
PubMed 29359461Schmidt 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.
PubMed 26378939
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Gastrointestinal, Thoracical or Urogenital Cancer Surgery.
- ClinicalTrials.gov ID
- NCT01278537
- Acronym / sponsor ID
- PERATECS / PERATECS
- Conditions
- Cancer
- Keywords
- elderly, cancer surgery, quality of life, empowerment, shared-decision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Feb 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empowerment, shared-decision making, | Experimental | Behavioral: InformationPatients receive a booklet with informations. Assessment of health-related risk factors. Assessment of psychological and physical social support Delirium protection. Early mobilization. |
| control group | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InformationBooklet, motivational interviewing, brief advice | Behavioural | Empowerment, shared-decision making, |
Primary outcome
Length of hospital stay
Time frame: within the first month
Quality of life
Time frame: within the first year
5 secondary outcomes
Readmission rate
Time frame: within the first three months
Short-term complications
Time frame: within the first months
Overall mortality
Time frame: within one year
Depression
Time frame: within the first year
Stress
Time frame: within the first month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
- Derived from this study: PubMed 38870573Scholtz 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.
- Derived from this study: PubMed 31668693Mueller 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.
- Derived from this study: PubMed 29359461Scholtz 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.
- Derived from this study: PubMed 26378939Schmidt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD Prof. study chair
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information in people with Cancer, run by Charite University, Berlin, Germany at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: within the first month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01278537, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2014.