- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02170168
The Orkdal Model. Collaboration Between Specialist and Community Care Within Palliative Cancer Care
The Orkdal Model. Development, Implementation and Evaluation of Collaboration Between Specialist and Community Care Within Palliative Cancer Care
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Agdenes, Norway
- Agdenes community care
-
Aukra, Norway
- Aukra community care
-
Eide, Norway
- Eide community care
-
Fræna, Norway
- Fræna community care
-
Frøya, Norway
- Frøya community care
-
Halsa, Norway
- Halsa community care
-
Hemne, Norway
- Hemne community care
-
Hitra, Norway
- Hitra community care
-
Meldal, Norway
- Meldal community care
-
Midsund, Norway
- Midsund community care
-
Molde, Norway
- Molde Hospital
-
Molde, Norway
- Molde community care
-
Nesset, Norway
- Nesset community care
-
Oppdal, Norway
- Oppdal community care
-
Orkdal, Norway
- Oppdal community care
-
Orkdal, Norway
- Orkdal Hospital
-
Rauma, Norway
- Rauma community care
-
Rennebu, Norway
- Rennebu community care
-
Rindal, Norway
- Rindal community care
-
Skaun, Norway
- Skaun community care
-
Snillfjord, Norway
- Snillfjord community care
-
Sunndal, Norway
- Sunndal community care
-
Surnadal, Norway
- Surnadal community care
-
Trondheim, Norway
- St Olavs Hospital
-
Vestnes, Norway
- Vestnes community care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria (Patients):
- 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
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.
Inclusion Criteria (Health care providers)
- 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.
Exclusion Criteria (Patients):
- Receiving anti-cancer treatment with curative intent
Exclusion Criteria (Carers)
- not able to complete the assessments
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
a standardised care pathway, an educational programme and information to general public, patients and their carers
|
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
|
a standardised care pathway, an educational programme and information to general public, patients and their carers
|
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
|
a standardised care pathway, an educational programme and information to general public, patients and their carers
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proportion of patient's time spent at home the last 3 months of life
Time Frame: 3 years
|
time in days
|
3 years
|
carers' health related quality of life (HRQOL) 6 months after patient's death
Time Frame: 3 years
|
as measured by the total score of the RAND-Short Form-36
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of home deaths
Time Frame: 3 years
|
3 years
|
|
Use of tumor directed treatment the last 3 months of life
Time Frame: 3 years
|
radiotherapy and chemotherapy
|
3 years
|
change over time in health care providers' knowledge and skills
Time Frame: 3 years
|
3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reported health-related quality of life
Time Frame: 3 years
|
measured by the total score of the European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire EORTC QLQ C15
|
3 years
|
place of death
Time Frame: 3 years
|
if place of death is in accordance with patients' wish as reported at inclusion
|
3 years
|
distribution of health care services usage
Time Frame: 3 yeart
|
between specialist and community care
|
3 yeart
|
total cost per patient
Time Frame: 3 years
|
3 years
|
|
share of specialist and community care costs
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jo-Åsmund Lund, MD PhD, St. Olavs Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014/212
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms
-
GlaxoSmithKlineCompleted
-
Amphia HospitalRecruitingColonic Neoplasms MalignantNetherlands
-
Marquette General Health SystemUpper Michigan Brain Tumor CenterWithdrawnGlioma | MeningiomaUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
European Association for Endoscopic SurgeryWithdrawn
-
John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedUterine Cervical Neoplasms | Prostatic Neoplasms | Rectal Neoplasms | Endometrial Neoplasms | Anus NeoplasmsUnited States
-
GlaxoSmithKlineRecruitingNeoplasms, RectalUnited States, France, Italy, Japan, Spain, United Kingdom, Germany, Korea, Republic of, Canada, Netherlands
-
Russian Society of Colorectal SurgeonsRecruitingNeoplasms,ColorectalRussian Federation
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Novartis PharmaceuticalsBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsUnited States, Germany, Belgium, Canada, Spain, United Kingdom, Taiwan, France, Switzerland, Sweden, Portugal, New Zealand, Italy, Slovakia, Australia, Austria, Brazil, Hong Kong
Clinical Trials on integrated palliative care program
-
Massachusetts General HospitalAmerican Society of Clinical OncologyCompletedNon-small Cell Lung CancerUnited States
-
National Taiwan University HospitalNot yet recruitingPeritoneal Dialysis | ESRD
-
National Cancer Centre, SingaporeDuke-NUS Graduate Medical SchoolCompleted
-
European Organisation for Research and Treatment...Not yet recruiting
-
US Department of Veterans AffairsCompleted
-
NYU Langone HealthCompletedChronic Kidney DiseasesUnited States
-
National Cancer Center, KoreaCompletedDepression | Pancreatic Cancer | Biliary Tract Cancer | Cancer PainKorea, Republic of
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompleted
-
Laval UniversityFonds de la Recherche en Santé du QuébecCompleted
-
Assiut UniversityRecruiting