Neoplasia ProstatePALLiONNCT03088202
PALLiON - PALLiative Care In ONcology
A study testing Educational program, Standardized care pathways and Early palliative care in people with Neoplasia Prostate, run by Oslo University Hospital at 12 sites in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasia Prostate
- What is being tested?
- Educational program, Standardized care pathways and Early palliative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 12 sitesNorway
- Study dates
- 22 Mar 2017to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Norway12 sites
Ålesund Hospital Trust
Ålesund
Nordland Hospital Trust
Bodø
Førde Hospital Trust
Førde
Østfold Hospital Trust
Fredrikstad, 1714
Sørlandet Hospital Trust
Kristiansand
Akershus University Hospital
Oslo
Oslo University Hospital
Oslo
Telemark Hospital Trust
Skien
Stavanger University Hospital
Stavanger
Vestfold Hospital trust
Tønsberg
University Hospital of North Norway
Tromsø, Troms, 9019
Norwegian University of Science and Technology
Trondheim, 0730
About this study
Official title: PALLiON - PALLiative Care In ONcology - a Cluster-randomized Trial to Improve the Care for Cancer Patients With a Short Life Expectancy
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.
Read the 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.
- Conditions
- Neoplasia Prostate
- Being tested
- Educational program, Standardized care pathways, Early palliative care
- Keywords
- cancer, palliative care, PROMs, survival, QoL, referral
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programOther
E-learning lectures, group exercises, skills training
Standardized care pathwaysOther
Pathways for systematic follow-up
Early palliative careOther
Compulsory referral to palliative care at inclusion
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Educational program Standardized care pathways Early palliative care Receives: Other: Educational program; Other: Standardized care pathways; Other: Early palliative care |
| Control arm | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of chemotherapy
Number of patients who receive chemotherapy during their last 3 months of life
Measured: 3 months before death
Secondary outcomes (3)
Initiation and discontinuation of chemotherapy
Number of patients who start and discontinue chemo, and number of cycles
Measured: 3 months before death
Use of artificial nutrition
Number of patients who receive artificial nutrition during their last month of life
Measured: 1 month before death
Use of concomitant medication
Number of patients who receive concomitant medication during their last month of life
Measured: 1 month before death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start22 Mar 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 Neoplasia ProstateStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Principal investigator, Marianne Jensen Hjermstad, Oslo University Hospital
- Investigators
- Jon H Loge, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088202
- Sponsor's protocol ID
- 2016/1220REK
- Acronym
- PALLiON
- Status last verified
- Mar 2023
- First submitted
- 30 Jan 2017
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If desired, other collaborators may use data collected at their own institution. However, this is subject to approval from the study scientific committee, and only applies after publication of the main study publication
Publications
Guldhav 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.
PubMed 42394710Hjermstad 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.
PubMed 38193250Lundeby 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.
PubMed 36919800Hjermstad 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.
PubMed 32241299
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PALLiON - PALLiative Care In ONcology - a Cluster-randomized Trial to Improve the Care for Cancer Patients With a Short Life Expectancy
- ClinicalTrials.gov ID
- NCT03088202
- Acronym / sponsor ID
- PALLiON / 2016/1220REK
- Conditions
- Neoplasia Prostate
- Keywords
- cancer, palliative care, PROMs, survival, QoL, referral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Mar 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Educational program, Other: Standardized care pathways, Other: Early palliative careEducational program Standardized care pathways Early palliative care |
| Control arm | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Educational programE-learning lectures, group exercises, skills training | Other | Intervention arm |
| Standardized care pathwaysPathways for systematic follow-up | Other | Intervention arm |
| Early palliative careCompulsory referral to palliative care at inclusion | Other | Intervention arm |
Primary outcome
Use of chemotherapy
Time frame: 3 months before death
Number of patients who receive chemotherapy during their last 3 months of life
3 secondary outcomes
Initiation and discontinuation of chemotherapy
Time frame: 3 months before death
Use of artificial nutrition
Time frame: 1 month before death
Use of concomitant medication
Time frame: 1 month before death
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 24 Mar 2023.
- Derived from this study: PubMed 42394710Guldhav 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.
- Derived from this study: PubMed 38193250Hjermstad 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.
- Derived from this study: PubMed 36919800Lundeby 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.
- Derived from this study: PubMed 32241299Hjermstad 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.
- Individual participant dataSharing planned: Yes. If desired, other collaborators may use data collected at their own institution. However, this is subject to approval from the study scientific committee, and only applies after publication of the main study publication
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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.
Jon H Loge, PhD principal investigator
Professor
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program, Standardized care pathways and Early palliative care in people with Neoplasia Prostate, run by Oslo University Hospital at 12 sites in Norway.
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 9 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: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Norway. 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?
Use of chemotherapy (time frame: 3 months 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 NCT03088202, 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 24 Mar 2023.