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NeoplasmsNCT02170168

The Orkdal Model. Collaboration Between Specialist and Community Care Within Palliative Cancer Care

An observational study of Neoplasms, run by St. Olavs Hospital at 25 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
integrated palliative care program
How many people
969 participants
Where
25 sitesNorway
Study dates
Nov 2014to 30 Sep 2022
Phase
Observational
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

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)

Who may be able to join

  • 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
Show all 13Show fewer
  • Inclusion criteria (Carers) (a carer a person identified as such by the patient)
  • 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.

Who cannot join

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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Norway25 sites

  • Agdenes community care

    Agdenes

  • Aukra community care

    Aukra

  • Eide community care

    Eide

  • Fræna community care

    Fræna

  • Frøya community care

    Frøya

  • Halsa community care

    Halsa

  • Hemne community care

    Hemne

  • Hitra community care

    Hitra

  • Meldal community care

    Meldal

  • Midsund community care

    Midsund

  • Molde community care

    Molde

  • Molde Hospital

    Molde

  • Nesset community care

    Nesset

  • Oppdal community care

    Oppdal

  • Oppdal community care

    Orkdal

  • Orkdal Hospital

    Orkdal

  • Rauma community care

    Rauma

  • Rennebu community care

    Rennebu

  • Rindal community care

    Rindal

  • Skaun community care

    Skaun

  • Snillfjord community care

    Snillfjord

  • Sunndal community care

    Sunndal

  • Surnadal community care

    Surnadal

  • St Olavs Hospital

    Trondheim

  • Vestnes community care

    Vestnes

Other trials in Norway

About this study

Official title: The Orkdal Model. Development, Implementation and Evaluation of Collaboration Between Specialist and Community Care Within Palliative Cancer Care

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.

Read the detailed description

This study will be a prospective controlled observational pre-post study. The intervention consists of three parts: a standardised care pathway, an educational programme and information to general public, patients and their carers. Data from patients, carers and health care providers (physicians, nurses and nurse assistants) will be collected before the model is implemented (pre-intervention part) and after final implementation (post-intervention part). In addition, a comparison with a similar patient population, carers and health care providers will be conducted. A local hospital in the county of Romsdal and community care in the same region will be used as control.

Added January 2020: The study was in 2018 extended to also evaluate the effect of implementing "advance care planning" in the county of Møre and Romsdal. Møre and Romsdal started implementation of "advance care planning" in January 2018. The evaluation of "advance care planning in Møre and Romsdal" has the same endpoints as the evaluation of the Orkdal model trial.

Added December 17th, 2021: Inclusion of participants (patients, carers and healthcare professionals) is from Sept 2018 to March 2021. Follow-up ends in Sept. 2022.

Conditions
Neoplasms
Being tested
integrated palliative care program
Keywords
Community health services, Models, organizational, Referral and consultation, Palliative medicine, Terminal care
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • integrated palliative care programOther

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

Study groups in NCT02170168
Study groupRoleWhat they receive
Orkdal region patientscancer patients participating in a integrated palliative care program for diagnostics, treatment, care and follow-up in and between hospital care and 13 municipalities
Receives: Other: integrated palliative care program
Romsdal county patientscontrol 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 carerscarers 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
Receives: Other: integrated palliative care program
Romsdal county carerscarers 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 providersHealth 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
Receives: Other: integrated palliative care program
Romsdal county health care providersHealth 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    time in days

    Measured: 3 years

  2. 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

    Measured: 3 years

Secondary outcomes (3)

  1. Number of home deaths

    Measured: 3 years

  2. Use of tumor directed treatment the last 3 months of life

    radiotherapy and chemotherapy

    Measured: 3 years

  3. change over time in health care providers' knowledge and skills

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion31 Mar 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
969 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02170168
Sponsor's protocol ID
2014/212
Status last verified
Apr 2023
First submitted
19 Jun 2014
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38744750

  • 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.

    PubMed 38662520

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms, run by St. Olavs Hospital at 25 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 13 inclusion and 2 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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?

proportion of patient's time spent at home the last 3 months of life (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT02170168, which also lists 2 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 13 Apr 2023.

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