NCT03088202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
659

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

5.8 years

First QC Date

January 30, 2017

Last Update Submit

March 23, 2023

Conditions

Neoplasia Prostate

Keywords

cancerpalliative carePROMssurvivalQoLreferral

Outcome Measures

Primary Outcomes (1)

  • Use of chemotherapy

    Number of patients who receive chemotherapy during their last 3 months of life

    3 months before death

Secondary Outcomes (3)

  • Initiation and discontinuation of chemotherapy

    3 months before death

  • Use of artificial nutrition

    1 month before death

  • Use of concomitant medication

    1 month before death

Study Arms (2)

Intervention arm

EXPERIMENTAL

Educational program Standardized care pathways Early palliative care

Other: Educational programOther: Standardized care pathwaysOther: Early palliative care

Control arm

NO INTERVENTION

Usual care

Interventions

Educational programOTHER

E-learning lectures, group exercises, skills training

Intervention arm
Standardized care pathwaysOTHER

Pathways for systematic follow-up

Intervention arm
Early palliative careOTHER

Compulsory referral to palliative care at inclusion

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University Hospital of North Norway

Tromsø, Troms, 9019, Norway

Location

Ålesund Hospital Trust

Ålesund, Norway

Location

Nordland Hospital Trust

Bodø, Norway

Location

Østfold Hospital Trust

Fredrikstad, 1714, Norway

Location

Førde Hospital Trust

Førde, Norway

Location

Sørlandet Hospital Trust

Kristiansand, Norway

Location

Akershus University Hospital

Oslo, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Telemark Hospital Trust

Skien, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

Norwegian University of Science and Technology

Trondheim, 0730, Norway

Location

Vestfold Hospital trust

Tønsberg, Norway

Location

Related Publications (3)

  • Hjermstad 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: 38193250DERIVED

  • Lundeby 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: 36919800DERIVED

  • 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.

    PMID: 32241299DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jon H Loge, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking, the randomization applies to institutions, not patients
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2017

First Posted

March 23, 2017

Study Start

March 22, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
end 2019
Access Criteria
co-authorship use of own data for quality assurance / publications

Locations

NO(12)