Clinical trial NCT03088202: PALLiON - PALLiative Care In ONcology
Official title: PALLiON - PALLiative Care In ONcology - a Cluster-randomized Trial to Improve the Care for Cancer Patients With a Short Life Expectancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasia Prostate
Keywords: cancer
palliative care
PROMs
survival
QoL
referral
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2017-03-23
Enrollment: 659
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Patients with incurable disease who receive intensive treatment at EoL have worse quality of life (QoL) compared with those receiving symptomatic treatment. Also, a PC approach at an early stage in patients with unfavorable prognosis may improve patients' QoL and symptom control, may lead to prolonged survival and give patients and caregivers a more realistic perspective on the disease and prognosis. Further, there is documentation that caregivers of patients with advanced cancer are generally more satisfied and report less depressive symptoms with an early introduction of PC.

These and related findings in the wake of a study (NEJM 2010) initiated the current debate and have made international stakeholders advocate a stronger integration of oncology and PC for patients with incurable cancer. Despite a rapid development of PC services during the last 15-20 years, there is still a distinct separation between oncology and PC in Norway as in other Western countries. This infers that the potential for optimal care during the last phase of life for those patients has not been fully explored, despite the documented advantages for both patients and caregivers. However, results from studies on integration of oncology and PC from other countries e.g. the USA, may not be directly transferable to Norway, given the different health care organizations, reimbursement issues and the different indications for and the high degree of hospice use.

Information given to cancer patients and caregivers about the disease and its treatment is important at all stages of disease, and is crucial in relation to PC in order to facilitate shared decision making, and improve satisfaction with care, patients' sense of control, QoL and communication with patient and caregivers. As PC also aims to improve the QoL of caregivers waiting to include caregivers until patients are in their last weeks or days of life may not adequately address patient or caregiver distress. Further, the benefits of early integration of PC on caregiver's distress and QoL remain inconclusive.

Thus, the overall aim of PALLiON is to improve the quality and efficacy of cancer care by implementing an early integration of oncology and PC in patients with advanced cancer who receive chemotherapy. The long-term objective is a change of today's oncology practice. Today, the method of referral to PC is most often based on care needs in contrast to referrals based on diagnosis and prognosis used in the RCTs that have documented favorable results. As we know that the timing of referral is important to optimize the benefits of PC, we aim to change this practice.

The implementation method in PALLiON is a complex intervention consisting of a) a structured educational program for oncologists, palliative care physicians and nurses, b) standardized care pathways with a systematic integration of oncology and palliative care for each of the included cancer diagnoses, and c) systematic use of Eir - an electronic assessment tool for patient-reported outcomes (PROMs), in the standardized care pathways, combined with evidence-based treatment recommendations in the clinical consultations.

The design makes it possible to evaluate the effect of an early integration of oncology and PC at the institutional and patient levels between the intervention and control arms. Further, a potential effect of the intervention at each of the centers in the intervention arm can be evaluated by comparing the post-intervention data with historical data e.g. on use of chemotherapy, number of re-admissions / emergency admissions in the very last stages of life as appropriate.

Eligibility criteria: 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

Primary outcomes:
measure: Use of chemotherapy
timeFrame: 3 months before death
Secondary outcomes:
measure: Initiation and discontinuation of chemotherapy
timeFrame: 3 months before death
measure: Use of artificial nutrition
timeFrame: 1 month before death
measure: Use of concomitant medication
timeFrame: 1 month before death
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
city: Bodø
country: Norway
facility: Nordland Hospital Trust
city: Fredrikstad
country: Norway
facility: Østfold Hospital Trust
city: Førde
country: Norway
facility: Førde Hospital Trust
city: Kristiansand
country: Norway
facility: Sørlandet Hospital Trust
city: Oslo
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Skien
country: Norway
facility: Telemark Hospital Trust
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
city: Tønsberg
country: Norway
facility: Vestfold Hospital trust
city: Ålesund
country: Norway
facility: Ålesund Hospital Trust
Study officials:
affiliation: Professor
name: Jon H Loge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hjermstad 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.