PALLiON - PALLiative Care In ONcology

A major concern in today's oncology is the complexity of treatment that increases costs. A main contributor is the increasing use of chemo- and radiotherapy during end of life (EoL: the last 12 months of life). Importantly, intensive chemotherapy in EoL has uncertain efficacy, may result in frequent hospitalizations and less time spent at home. Also, patients with incurable disease who receive intensive treatment at EoL have worse quality of life (QoL). A systematic palliative care (PC) approach that focuses on optimal symptom management and maintenance of QoL of patients and family is often introduced too late in the disease trajectory. Studies indicate that early introduction of PC in patients with unfavorable prognosis may improve QoL and other symptoms and prolong survival. These and related findings have made international stakeholders advocate a stronger integration of oncology and PC for patients with incurable cancer. The present project is a national multicenter cluster-randomized trial (RCT) in 12 oncology departments in all 4 Norwegian health regions. The project tests the efficacy of a complex tripod intervention that integrates oncology and PC for cancer patients with a life-expectancy \<12 months who receive chemotherapy and includes: A) systematic electronic assessment of symptoms, B) implementation of standardized care pathways and C) an education program for oncologists/PC physicians. The PC pathway focuses on the patient's journey through the PC trajectory including EoL care in order to improve quality of care and reduce the variability in clinical practice and costs. The intervention aims at empowering physicians, patients and relatives and promoting shared-decision-making.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* A verified metastatic or locally advanced cancer of the upper GI tract, lower GI tract, pancreas, liver, breast, bladder, prostate, kidney, cholangiocarcinoma, or malignant melanoma
* Defined as a palliative care patient, with expected life expectancy of \<12 months
* Scheduled to start what is perceived as last line of chemotherapy (definition: tumor directed medical therapy)

  o Observe: different time points for inclusion and line of treatment apply for the specific diagnoses
* Age \> 18 years
* Fluency in written and oral Norwegian
* Physically and cognitively able to provide written informed consent, based on clinical judgment
* Scheduled to receive all oncological and specialized palliative treatment at the participating hospital
* World Health Organization (WHO) performance status 0-2

Exclusion Criteria:

* Any serious psychiatric diagnosis (e.g. psychotic, bipolar disorder), substance abuse or cognitive impairment as judged by standard clinical criteria (disturbed consciousness, disorientation to time/place and attention deficits) at the discretion of the attending physician that precludes completion of PROs
* A cancer diagnosis other than the ones above
* Multiple malignancies
* Serious substance abuse
* Already included in a palliative care program

• DERIVEDGuldhav KV, McAleavey AA, Aass N, Andersen S, Christensen BM, Dajani O, Eldal K, de Glas NA, Garresori H, Hamre H, Haukland EC, Hegland PA, Lundeby T, Lohre ET, Paulsen O, Wester T, Kaasa S, Hjermstad MJ, Andersen JR. Caregiver satisfaction with early integrated palliative care in oncology: secondary outcomes from the PALLiON cluster-RCT. Front Oncol. 2026 Jun 18;16:1787814. doi: 10.3389/fonc.2026.1787814. eCollection 2026. PMID 42394710
• DERIVEDHjermstad MJ, Pirnat A, Aass N, Andersen S, Astrup GL, Dajani O, Garresori H, Guldhav KV, Hamre H, Haukland EC, Jordal F, Lundeby T, Lohre ET, Mjaland S, Paulsen O, Semb KA, Staff ES, Wester T, Kaasa S. PALLiative care in ONcology (PALLiON): A cluster-randomised trial investigating the effect of palliative care on the use of anticancer treatment at the end of life. Palliat Med. 2024 Feb;38(2):229-239. doi: 10.1177/02692163231222391. Epub 2024 Jan 9. PMID 38193250
• DERIVEDLundeby T, Finset A, Kaasa S, Wester TE, Hjermstad MJ, Dajani O, Wist E, Aass N. A complex communication skills training program for physicians providing advanced cancer care - content development and barriers and solutions for implementation. J Commun Healthc. 2023 Mar;16(1):46-57. doi: 10.1080/17538068.2022.2039468. Epub 2022 Feb 20. PMID 36919800
• DERIVEDHjermstad MJ, Aass N, Andersen S, Brunelli C, Dajani O, Garresori H, Hamre H, Haukland EC, Holmberg M, Jordal F, Krogstad H, Lundeby T, Lohre ET, Mjaland S, Nordbo A, Paulsen O, Schistad Staff E, Wester T, Kaasa S, Loge JH. PALLiON - PALLiative care Integrated in ONcology: study protocol for a Norwegian national cluster-randomized control trial with a complex intervention of early integration of palliative care. Trials. 2020 Apr 2;21(1):303. doi: 10.1186/s13063-020-4224-4. PMID 32241299