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CanceriCareNCT05575791

Evaluation of Preoperative Acceptance of Proactive Palliative Care Intervention

An observational study of Cancer and Heart Failure, run by Charite University, Berlin, Germany at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Advances in medicine have led to an increased life expectancy even with complex disease courses of malignant diseases. This leads to frequent critical situations for patients and high risk surgical interventions. Read more about this study

Who is it for?
Ages 19 years and older
How many people
100 participants
Where
1 siteGermany
Study dates
1 Dec 2022to 30 Nov 2023
How long will I take part?
1 Week
Phase
Observational
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The participants will be selected out of the population consulted at the anesthesiology outpatient clinic of the University hospital Berlin - Charite.

Who may be able to join

  • over 18 years
  • one elective operation with medium or high cardiac risk
  • And in addition at least one of the following criteria:
  • serious comorbidity pulmonary: Emphysema and / or COPD >= 2 after GOLD cardiac: NYHA > = 2
  • and / or a metastatic malignancy
  • ASA physical status classification >= 3 and pre-frail or frail

Who cannot join

  • legal care
  • Emergency operation
  • any reasons which contradict inclusion in studies , e.g. cognitive deficit and lack of language skills
  • Pregnant / breastfeeding women

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting

  • Department of Anesthesia and operative intensive Care, Campus Benjamin Franklin, Charité - University Hospital Berlin

    Steglitz, State of Berlin, 12203

    Sascha Treskatsch, MD, 004930-450 551522, sascha.tresktasch@charite.de

    Recruiting

Other trials in Germany

About this study

Advances in medicine have led to an increased life expectancy even with complex disease courses of malignant diseases.

This leads to frequent critical situations for patients and high risk surgical interventions. The majority of patients and their practitioners are not prepared for the consequences of a complex and possibly fatal course.

Read more

Palliative medicine makes it possible to anticipate the further course of the disease. As a result, palliative medicine has become increasingly important. The beginning of palliative medical interventions has extended from accompaniment limited to the dying phase to earlier phases of the disease.

An early integration of palliative medicine showed a positive effect on the quality of life, the degree of depression and survival in patients suffering from cancer, for example. Furthermore, patients were more able to accept a change in therapy goal at the end of life. Similar results were shown for patients with a non-malignant severe disease such as COPD or heart failure.

What needs further investigating is how to adequately screen and identify the patient populations who could benefit from early palliative care, so that they are prepared for potentially critical and life-threatening situations.

The investigator's objective is therefore whether the Anesthesiology Outpatient Clinic is a suitable screening location for initiating early integrated palliative care for patients with a serious, life-shortening illness and a high perioperative risk.

Medical subject headings
Neoplasms, Heart Failure, Pulmonary Disease, Chronic Obstructive, Postoperative Complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptance of the preoperative palliative counseling offer

    Percentage of patients who accept the palliative counseling offer in relation to the total number of patients identified in the screening of the anesthesia outpatient clinic

    Measured: through study completion, an average of 1 year

Secondary outcomes (6)

  1. Advance planning documents

    Percentage of patients who, as a result of the palliative medical consultation offer, create or want to create a living will or power of attorney

    Measured: through study completion, an average of 1 year

  2. Postoperative palliative counseling

    Percentage of patients who would like further palliative medical advice postoperatively

    Measured: through study completion, an average of 1 year

  3. Acceptance of the preoperative palliative counseling offer depending on the underlying disease

    Percentage of patients with and without a malignant disease who accept the counseling offer

    Measured: through study completion, an average of 1 year

  4. Therapy target decision-making situations

    Percentage of patients in whom a decision to limit therapy occurs in the postoperative course

    Measured: through study completion, an average of 1 year

  5. Gender difference

    Percentage of female patients who accept the counseling offer in relation to male patients

    Measured: through study completion, an average of 1 year

  6. Therapy goal decisions postoperatively

    Percentage of patients who do not accept the offer of counseling and who have difficult therapy goal decisions postoperatively

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2022
  2. Study start1 Dec 2022
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT05575791
Sponsor's protocol ID
EA1/292/20
Acronym
iCare
Status last verified
Feb 2023
First submitted
21 Feb 2022
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

    PubMed 20818875

  • Vanbutsele G, Pardon K, Van Belle S, Surmont V, De Laat M, Colman R, Eecloo K, Cocquyt V, Geboes K, Deliens L. Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial. Lancet Oncol. 2018 Mar;19(3):394-404. doi: 10.1016/S1470-2045(18)30060-3. Epub 2018 Feb 3.

    PubMed 29402701

  • Vanbutsele G, Van Belle S, Surmont V, De Laat M, Colman R, Eecloo K, Naert E, De Man M, Geboes K, Deliens L, Pardon K. The effect of early and systematic integration of palliative care in oncology on quality of life and health care use near the end of life: A randomised controlled trial. Eur J Cancer. 2020 Jan;124:186-193. doi: 10.1016/j.ejca.2019.11.009. Epub 2019 Dec 5.

    PubMed 31812934

  • Maltoni M, Scarpi E, Dall'Agata M, Zagonel V, Berte R, Ferrari D, Broglia CM, Bortolussi R, Trentin L, Valgiusti M, Pini S, Farolfi A, Casadei Gardini A, Nanni O, Amadori D; Early Palliative Care Italian Study Group (EPCISG). Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial. Eur J Cancer. 2016 Sep;65:61-8. doi: 10.1016/j.ejca.2016.06.007. Epub 2016 Jul 26.

    PubMed 27472648

  • Haun MW, Estel S, Rucker G, Friederich HC, Villalobos M, Thomas M, Hartmann M. Early palliative care for adults with advanced cancer. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD011129. doi: 10.1002/14651858.CD011129.pub2.

    PubMed 28603881

  • Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.

    PubMed 25465642

  • Hauptman PJ, Havranek EP. Integrating palliative care into heart failure care. Arch Intern Med. 2005 Feb 28;165(4):374-8. doi: 10.1001/archinte.165.4.374.

    PubMed 15738365

  • Zhou K, Mao Y. Palliative care in heart failure : A meta-analysis of randomized controlled trials. Herz. 2019 Aug;44(5):440-444. doi: 10.1007/s00059-017-4677-8. Epub 2018 Feb 21.

    PubMed 29468259

  • Siouta N, Heylen A, Aertgeerts B, Clement P, Van Cleemput J, Janssens W, Menten J. Early integrated palliative care in chronic heart failure and chronic obstructive pulmonary disease: protocol of a feasibility before-after intervention study. Pilot Feasibility Stud. 2019 Feb 21;5:31. doi: 10.1186/s40814-019-0420-y. eCollection 2019.

    PubMed 30834140

  • Brumley R, Enguidanos S, Jamison P, Seitz R, Morgenstern N, Saito S, McIlwane J, Hillary K, Gonzalez J. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc. 2007 Jul;55(7):993-1000. doi: 10.1111/j.1532-5415.2007.01234.x.

    PubMed 17608870

  • Ma J, Chi S, Buettner B, Pollard K, Muir M, Kolekar C, Al-Hammadi N, Chen L, Kollef M, Dans M. Early Palliative Care Consultation in the Medical ICU: A Cluster Randomized Crossover Trial. Crit Care Med. 2019 Dec;47(12):1707-1715. doi: 10.1097/CCM.0000000000004016.

    PubMed 31609772

  • Yefimova M, Aslakson RA, Yang L, Garcia A, Boothroyd D, Gale RC, Giannitrapani K, Morris AM, Johanning JM, Shreve S, Wachterman MW, Lorenz KA. Palliative Care and End-of-Life Outcomes Following High-risk Surgery. JAMA Surg. 2020 Feb 1;155(2):138-146. doi: 10.1001/jamasurg.2019.5083.

    PubMed 31895424

  • Cancer Control: Knowledge into Action: WHO Guide for Effective Programmes: Module 5: Palliative Care. Geneva: World Health Organization; 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK195248/

    PubMed 24716263

  • Chan R, Ueno R, Afroz A, Billah B, Tiruvoipati R, Subramaniam A. Association between frailty and clinical outcomes in surgical patients admitted to intensive care units: a systematic review and meta-analysis. Br J Anaesth. 2022 Feb;128(2):258-271. doi: 10.1016/j.bja.2021.11.018. Epub 2021 Dec 17.

    PubMed 34924178

  • Morgeli R, Wollersheim T, Spies C, Balzer F, Koch S, Treskatsch S. [How to Reduce the Rate of Postoperative Complications in Frail Patients?]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2017 Nov;52(11-12):785-797. doi: 10.1055/s-0043-104685. Epub 2017 Nov 20. German.

    PubMed 29156482

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Heart Failure, run by Charite University, Berlin, Germany at 1 site 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptance of the preoperative palliative counseling offer (time frame: through study completion, an average of 1 year). 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 NCT05575791, which also lists 24 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 Feb 2023.

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