NCT02170168

Brief Summary

The overall aim of this project is to deliver better health care services through improved coordination of cancer care within specialist care (at the local hospital Orkdal Hospital) and community care (13 municipalities in the Orkdal region, Norway), and between these two levels in the health care system. "The Orkdal model" is developed and will be implemented and evaluated within cancer care. Cancer patients living in one of the 12 municipalities participating in the formal collaboration "Samhandlingsenheten i Orkdalsregionen" (SIO), or the municipality of Oppdal, having metastatic and/or loco-regional disease will be included in the study. Carers and health care providers will be included as well. Results from this project will be transferable to other parts of Norway and/or to other countries as well as to patients with other diagnoses causing complex conditions, such as chronic heart-, lung- and neurological disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
969

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

25 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

June 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

7.4 years

First QC Date

June 19, 2014

Last Update Submit

April 12, 2023

Conditions

Keywords

Community health servicesModels, organizationalReferral and consultationPalliative medicineTerminal care

Outcome Measures

Primary Outcomes (2)

  • proportion of patient's time spent at home the last 3 months of life

    time in days

    3 years

  • carers' health related quality of life (HRQOL) 6 months after patient's death

    as measured by the total score of the RAND-Short Form-36

    3 years

Secondary Outcomes (3)

  • Number of home deaths

    3 years

  • Use of tumor directed treatment the last 3 months of life

    3 years

  • change over time in health care providers' knowledge and skills

    3 years

Other Outcomes (5)

  • Patient reported health-related quality of life

    3 years

  • place of death

    3 years

  • distribution of health care services usage

    3 yeart

  • +2 more other outcomes

Study Arms (6)

Orkdal region patients

cancer patients participating in a integrated palliative care program for diagnostics, treatment, care and follow-up in and between hospital care and 13 municipalities

Other: integrated palliative care program

Romsdal county patients

control palliative care cancer patients in standard care, i.e. a local hospital in the county of Møre and Romsdal, Molde Hospital, and nine districts

Orkdal region carers

carers of cancer patients participating in a integrated palliative care program for diagnostics, treatment, care and follow-up in and between hospital care and 13 municipalities

Other: integrated palliative care program

Romsdal county carers

carers of cancer patients receiving standard care, i.e. in a local hospital in the county of Møre and Romsdal, Molde Hospital, and community care in nine districts

Orkdal region health care providers

Health care providers for cancer patients participating in a integrated palliative care program for diagnostics, treatment, care and follow-up in and between hospital care and 13 municipalities

Other: integrated palliative care program

Romsdal county health care providers

Health care providers for cancer patients receiving standard care, i.e. in a local hospital in the county of Møre and Romsdal, Molde Hospital, and community care in nine districts

Interventions

a standardised care pathway, an educational programme and information to general public, patients and their carers

Orkdal region carersOrkdal region health care providersOrkdal region patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients in need of palliative care, inhabitants of one of 22 municipalities in Central Norway, carers (1 per patient) and health care providers (community care and 2 regional hospitals)

You may qualify if:

  • Advanced loco-regional disease and/or metastatic cancer disease
  • For the intervention group in the Orkdal region: Inhabitant of one of the following thirteen districts: Surnadal, Halsa, Rindal, Hemne, Orkdal, Frøya, Hitra, Snillfjord, Agdenes, Meldal, Rennebu, Skaun, and Oppdal
  • For the intervention group in the Romsdal region: Inhabitiant of one of the following nine districts: Aukra, Molde, Eide, Vestnes, Sunndal, Fræna, Midsund, Nesset, Rauma
  • Acceptance of participation, based on information about the study and that participation is voluntary. Documented by a signed consent form.
  • Able to comply with the study procedures
  • Able to read and write Norwegian
  • the patient is eligible for the study
  • the patient has given his or her consent to allow the study nurse to approach the carer to participate in the study
  • the patient has identified the carer to be approached
  • acceptance of participation, based on information about the study and that participation is voluntary. Documented by a signed consent form.
  • has accepted to participate in the study
  • Acceptance of participation, based on information about the study and that participation is voluntary. Documented by an electronically signed consent form.

You may not qualify if:

  • Receiving anti-cancer treatment with curative intent
  • not able to complete the assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Agdenes community care

Agdenes, Norway

Location

Aukra community care

Aukra, Norway

Location

Eide community care

Eide, Norway

Location

Fræna community care

Fræna, Norway

Location

Frøya community care

Frøya, Norway

Location

Halsa community care

Halsa, Norway

Location

Hemne community care

Hemne, Norway

Location

Hitra community care

Hitra, Norway

Location

Meldal community care

Meldal, Norway

Location

Midsund community care

Midsund, Norway

Location

Molde community care

Molde, Norway

Location

Molde Hospital

Molde, Norway

Location

Nesset community care

Nesset, Norway

Location

Oppdal community care

Oppdal, Norway

Location

Oppdal community care

Orkdal, Norway

Location

Orkdal Hospital

Orkdal, Norway

Location

Rauma community care

Rauma, Norway

Location

Rennebu community care

Rennebu, Norway

Location

Rindal community care

Rindal, Norway

Location

Skaun community care

Skaun, Norway

Location

Snillfjord community care

Snillfjord, Norway

Location

Sunndal community care

Sunndal, Norway

Location

Surnadal community care

Surnadal, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Vestnes community care

Vestnes, Norway

Location

Related Publications (2)

  • Brenne AT, Lohre ET, Knudsen AK, Lund JA, Thronaes M, Driller B, Brunelli C, Kaasa S. Standardizing Integrated Oncology and Palliative Care Across Service Levels: Challenges in Demonstrating Effects in a Prospective Controlled Intervention Trial. Oncol Ther. 2024 Jun;12(2):345-362. doi: 10.1007/s40487-024-00278-3. Epub 2024 May 14.

  • Driller B, Talseth-Palmer B, Hole T, Stromskag KE, Brenne AT. Cancer patients have a reduced likelihood of dying in hospital with advance care planning in primary health care and a summarizing palliative plan: a prospective controlled non-randomized intervention trial. Scand J Prim Health Care. 2024 Sep;42(3):471-482. doi: 10.1080/02813432.2024.2346131. Epub 2024 Apr 25.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Jo-Åsmund Lund, MD PhD

    St. Olavs Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 23, 2014

Study Start

November 1, 2014

Primary Completion

March 31, 2022

Study Completion

September 30, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations