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CancerSPPCNCT07490106

Benefits of Early Collaboration Between Oncologists and Palliative Care Physicians in Cases of Unplanned Hospitalization for Patients With Metastatic Cancer

A study testing Early integrated palliative care and Usual oncological care in people with Cancer and Sarcoma Metastatic, run by Centre Oscar Lambret at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, national, interventional, cluster-randomized study, "stepped wedge" design. This study includes patients with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer, currently undergoing systemic palliative treatment and hospitalized on an unscheduled basis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Sarcoma Metastatic, Gynaecologic Cancer
What is being tested?
Early integrated palliative care and Usual oncological care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
493 participants
Where
1 siteFrance
Study dates
Oct 2026to Oct 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects aged 18 years and older;
  • Diagnosed with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer;
  • Currently undergoing systemic palliative treatment (no prospect of cure);
  • Hospitalized on an unscheduled basis (i.e., unplanned hospitalization for scheduled oncology treatments);
  • Patient covered by the French social security system;
  • Informed consent, written and signed.

Who cannot join

  • PS (WHO) = 4;
  • Patient receiving end-of-life care;
  • Patient opposed to the use of medical data for research purposes;
  • Person deprived of liberty or under guardianship;
  • Inability to undergo medical monitoring for the trial for geographical, social, or psychological reasons.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fanny BEN OUNE contact

+33320295896

promotion@o-lambret.fr

France1 site

  • Centre Oscar Lambret

    Lille, 59020

Other trials in France

About this study

This is a multicenter, national, interventional, cluster-randomized study, "stepped wedge" design. This study includes patients with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer, currently undergoing systemic palliative treatment and hospitalized on an unscheduled basis. The study will aim to evaluate the impact of early palliative care implementation for patients with metastatic or advanced cancer identified during an unplanned hospitalization.

Read the detailed description

This study will aim to evaluate the effectiveness of early palliative care for patients with metastatic or advanced cancer identified through unscheduled hospitalization in terms of reducing "aggressive" treatment.

Other objectives of the study include :

Compare approaches in terms of overall survival, treatment toxicities, advance directives, quality of life, anxiety, and depression.

  • Describing care according to the organization at the time of inclusion.
  • Evaluating the economic impact of early palliative care in patients with metastatic or advanced cancer through a medico-economic analysis combining cost-effectiveness and cost-utility analysis.
  • Evaluating interactions between the various stakeholders (palliative care physicians, supportive care physicians, oncologists).
Being tested
Early integrated palliative care, Usual oncological care
Keywords
Metastatic or Locally Advanced digestive, gynecological, ENT, or sarcoma cancer
Medical subject headings
Neoplasms, Gastrointestinal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early integrated palliative careOther

    Patients receive early integrated palliative care at the time of unplanned hospitalization for metastatic or advanced cancer. The intervention includes:

    • A palliative care consultation
    • A consultation with the treating oncologist
    • A multidisciplinary onco-palliative meeting to define a coordinated care plan

  • Usual oncological careOther

    Patients receive standard oncological care according to institutional practices. Palliative care is provided only when clinically indicated, without systematic early consultation at the time of unplanned hospitalization.

Study groups in NCT07490106
Study groupRoleWhat they receive
Early integrated palliative careExperimentalPatients receive early integrated palliative care following an unplanned hospitalization for metastatic or advanced cancer. The intervention includes a palliative care consultation, consultation with the treating oncologist, and a multidisciplinary onco-palliative discussion to define a shared care strategy. Implementation of an early collaboration between oncologists and palliative care physicians. At the time of unplanned hospitalization, patients receive a palliative care consultation, a consultation with their oncologist, and a multidisciplinary discussion (onco-palliative meeting) to define a coordinated care strategy.
Receives: Other: Early integrated palliative care
Usual oncological careActive comparatorPatients receive standard oncological management without systematic early involvement of palliative care. Palliative care may be introduced according to usual clinical practice. Standard oncological care provided according to institutional practices without systematic early palliative care consultation at the time of unplanned hospitalization.
Receives: Other: Usual oncological care

What is being measured

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

  1. Aggressiveness of end-of-life care (composite endpoint)

    Treatment will be considered aggressive if at least one of the following criteria is met (composite criterion):

    • Administration of systemic IV treatment (chemotherapy, targeted therapy, immunotherapy) within 14 days prior to death
    • At least one visit to the emergency room within 30 days prior to death
    • At least one admission to intensive care within 30 days prior to death
    • At least one admission to resuscitation within 30 days prior to death
    • Death in hospital outside of palliative care

    Measured: Assessed during the last 30 days of life and up to 14 days before death

Secondary outcomes (6)

  1. Components and additional indicators of aggressiveness of end-of-life care

    Each component of the primary composite endpoint will be analyzed separately, including: intravenous systemic anticancer therapy within 14 days before death, ≥1 emergency department visit within 30 days before death, ≥1 intensive care unit admission within 30 days before death, ≥1 resuscitation unit admission within 30 days before death, and hospital death outside a palliative care unit. Additional indicators of aggressiveness will also be evaluated: initiation of a new line of systemic therapy within 30 days before death, number of hospitalizations in the last 30 days of life, cumulative duration of hospitalization in the last 30 days of life, number of emergency department visits, ICU admissions, resuscitation admissions, and palliative care admission within the last 3 days of life.

    Measured: Assessed during the last 30 days of life and up to 14 days before death

  2. Overall survival

    Overall survival will be defined as the time from the date of the unplanned hospitalization leading to study inclusion until the date of death from any cause.

    Measured: From study inclusion until death from any cause (follow-up up to 12 months)

  3. Quality of life EORTC QLQ-C30 questionnaire

    Quality of life will be assessed using the EORTC QLQ-C30 questionnaire at baseline and every 3 months.

    Measured: Baseline and every 3 months until death or up to 12 months

  4. Quality of life MQOL-R questionnaire

    The quality of life will be evaluated via the McGill Quality of Life-Revised (MQOL-R) questionnaire at baseline and every 3 months.

    Measured: Baseline and every 3 months until death or up to 12 months

  5. Psychological distress and care pathway indicators

    Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and every 3 months. Additional indicators related to the care pathway will also be collected, including the presence of advance directives and the number of oncology consultations, palliative care consultations, and multidisciplinary onco-palliative meetings during follow-up.

    Measured: Baseline and every 3 months until death or up to 12 months

  6. Time Until Definitive Deterioration

    The Time Until Definitive Deterioration (TUDD) will be calculated from MQOL-R scores. Definitive deterioration is defined as a decrease of at least 1 point from baseline without any subsequent improvement greater than 1 point above the baseline score. TUDD will be defined as the time from inclusion to the first observation of definitive deterioration or death.

    Measured: Baseline and every 3 months until death or up to 12 months

Timeline

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

  1. First posted24 Mar 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2031 (estimated)
  4. Study completionOct 2031 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Sequential
Model description
This study is a multicenter, national, phase III cluster-randomized stepped-wedge trial evaluating the impact of early palliative care implementation for patients with metastatic or advanced cancer identified during an unplanned hospitalization. Participating centers represent the clusters. All centers start in the control phase (usual care) and subsequently cross over to the intervention phase according to a randomized implementation schedule. Clusters are randomized to the timing of implementation of the early palliative care intervention (12 or 24 months after study initiation). Randomization is stratified according to the expected recruitment rate per center (≤2 versus \>2 patients per month). This design allows sequential implementation of the intervention across centers while enabling comparison between control and intervention periods.
Masking
None (open label)
Enrolment
493 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07490106
Sponsor's protocol ID
SPPC-2503
Other IDs
PREPS-24-0053, 2025-A02238-41
Acronym
SPPC
Status last verified
Sep 2026
First submitted
16 Mar 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kovac T. [Protein glycolysation]. Med Pregl. 1987;40(1-2):55-9. No abstract available. Croatian.

    PubMed 3657724

  • Makker V, Colombo N, Casado Herraez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D; Study 309-KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Feb 3;386(5):437-448. doi: 10.1056/NEJMoa2108330. Epub 2022 Jan 19.

    PubMed 35045221

  • Mirallas O, Martin-Cullell B, Navarro V, Vega KS, Recuero-Borau J, Gomez-Puerto D, Lopez-Valbuena D, Salva de Torres C, Andurell L, Pedrola A, Berche R, Palmas F, Ucha JM, Villacampa G, Rezqallah A, Sanz-Beltran J, Bach R, Bueno S, Viaplana C, Molina G, Hernando-Calvo A, Aguilar-Company J, Roca M, Munoz-Couselo E, Martinez-Marti A, Alonso A, Eremiev S, Macarulla T, Oaknin A, Saura C, Elez E, Felip E, Penuelas A, Burgos R, Pardo PG, Garralda E, Tabernero J, Serradell S, Servitja S, Paez D, Dienstmann R, Carles J. Development of a prognostic model to predict 90-day mortality in hospitalised cancer patients (PROMISE tool): a prospective observational study. Lancet Reg Health Eur. 2024 Oct 9;46:101063. doi: 10.1016/j.lanepe.2024.101063. eCollection 2024 Nov.

    PubMed 39529819

  • Patel TL, Bouchal SR, Laing CM, Hubbard S. Diminuer le recours au service des urgences pour les patients externes presentant des symptomes aigus de cancer : revue integrative sur l'emergence des centres de soins d'urgence en cancerologie. Can Oncol Nurs J. 2021 Feb 1;31(1):36-50. doi: 10.5737/236880763113650. eCollection 2021 Winter. French.

    PubMed 38919462

  • Paillé, P. et Mucchielli, A. (2021). Chapitre 12. L'analyse thématique. L'analyse qualitative en sciences humaines et sociales - 5e éd. (p. 269 -357). Armand Colin. https://shs.cairn.info/l-analyse-qualitative-en-sciences-humaines--9782200624019-page-69?lang=fr.

  • Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa

  • Hemming K, Taljaard M. Reflection on modern methods: when is a stepped-wedge cluster randomized trial a good study design choice? Int J Epidemiol. 2020 Jun 1;49(3):1043-1052. doi: 10.1093/ije/dyaa077.

    PubMed 32386407

  • Whynes DK; TOMBOLA Group. Responsiveness of the EQ-5D to HADS-identified anxiety and depression. J Eval Clin Pract. 2009 Oct;15(5):820-5. doi: 10.1111/j.1365-2753.2008.01102.x.

    PubMed 19811595

  • Franken MD, de Hond A, Degeling K, Punt CJA, Koopman M, Uyl-de Groot CA, Versteegh MM, van Oijen MGH. Evaluation of the performance of algorithms mapping EORTC QLQ-C30 onto the EQ-5D index in a metastatic colorectal cancer cost-effectiveness model. Health Qual Life Outcomes. 2020 Jul 20;18(1):240. doi: 10.1186/s12955-020-01481-2.

    PubMed 32690011

  • Gray LA, Hernandez Alava M, Wailoo AJ. Mapping the EORTC QLQ-C30 to EQ-5D-3L in patients with breast cancer. BMC Cancer. 2021 Nov 18;21(1):1237. doi: 10.1186/s12885-021-08964-5.

    PubMed 34794404

  • Ahmed S, Simon J, Biondo P, Slobogian V, Shirt L, King S, Paolucci A, Pabani A, Hao D, Bossio E, Cross R, Monds T, Nieuwenhuis J, Sinnarajah A. Acceptability of automatic referrals to supportive and palliative care by patients living with advanced lung cancer: qualitative interviews and a co-design process. Res Involv Engagem. 2024 Apr 2;10(1):36. doi: 10.1186/s40900-024-00568-0.

    PubMed 38566198

  • Hannon B, Swami N, Pope A, Leighl N, Rodin G, Krzyzanowska M, Zimmermann C. Early Palliative Care and Its Role in Oncology: A Qualitative Study. Oncologist. 2016 Nov;21(11):1387-1395. doi: 10.1634/theoncologist.2016-0176. Epub 2016 Jul 22.

    PubMed 27449522

  • Vinant P, Joffin I, Serresse L, Grabar S, Jaulmes H, Daoud M, Abitbol G, Fouassier P, Triol I, Rostaing S, Brette MD, Colombet I; INSIGHT investigators. Integration and activity of hospital-based palliative care consultation teams: the INSIGHT multicentric cohort study. BMC Palliat Care. 2017 May 30;16(1):36. doi: 10.1186/s12904-017-0209-9.

    PubMed 28558731

  • Mignonat-Lecoanet C., Nahapetian H., Lecoanet A., Filbet M., " Modalités d'appel des soins palliatifs : enquête auprès des oncologues ", Médecine Palliative : Soins de Support - Accompagnement - Éthique, Volume 16, Issue 2, 2017, Pages 70-80, ISSN 1636-6522, https://doi.org/10.1016/j.medpal.2017.01.001

  • Hui D, Bruera E. Models of integration of oncology and palliative care. Ann Palliat Med. 2015 Jul;4(3):89-98. doi: 10.3978/j.issn.2224-5820.2015.04.01.

    PubMed 26231806

Questions about this trial

What is this clinical trial studying?

A study testing Early integrated palliative care and Usual oncological care in people with Cancer and Sarcoma Metastatic, run by Centre Oscar Lambret at 1 site in France.

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 5 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: opening soon, as of the sponsor's last update on 17 Sep 2026. 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 France. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Fanny BEN OUNE (+33320295896, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aggressiveness of end-of-life care (composite endpoint) (time frame: Assessed during the last 30 days of life and up to 14 days before death). 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 NCT07490106, which also lists 44 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 17 Sep 2026.

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