- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02716168
Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy (PSP)
October 16, 2020 updated by: Theis Trabjerg, University of Southern Denmark
Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial
Background International guidelines underline the importance of strengthening the coordination and continuity of cancer care.
The different roles of general practitioners and oncologists with regard to treatment, follow-up and rehabilitation during and after cancer treatment are often obscure to cancer patients.
Parallel courses of healthcare are often taking place instead of coordinated care characterized by continuity and partnership between care providers.
Patients may feel uncertain about the health professionals' skills and area of responsibility.
Healthcare seeking and support during and after cancer treatment may, therefore, be inappropriate, leaving patients feeling insecure and lost between care providers.The study aims to design and evaluate a new way of communication and shared decision-making that brings the patient, the oncologist and general practitioner together in a shared video-consultation in the early phase of chemotherapeutic treatment.
The effect of the intervention in addition to usual care will be tested in a randomized controlled trial at Vejle Hospital in the Region of Southern Denmark.
Based on sample size calculation, investigators intent to include 300 patients at the Department of Oncology and their general practitioners.
Results and process outcomes will be evaluated qualitatively and quantitatively, questionnaires to patients, general practitioners and oncologists, and data from registers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
281
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vejle, Denmark, 7100
- Department of Oncology, Vejle Hospital, Region of Southern Denmark
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Newly referred cancer patient scheduled for chemotherapy at the Department for Oncology, Vejle Hospital, Region of Southern Denmark
- Aged 18 years and over
- Able to speak and read Danish
- Mentally able to cooperate
- Listed with a general practitioner (98 % of the danish population)
- Written and verbal informed consent given
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video consultation
Video consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment
|
At the start of the patients chemotherapy treatment a shared video consultation between the patient, general practitioner and oncologist will bee arranged.
The video consultation should address distribution of roles, comorbidity, medicine, depression and anxiety symptoms, relatives and social resources.
|
No Intervention: usual care
Usual care.
The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shared Care questionnaire
Time Frame: 7 month after inclusion
|
Patient reported outcome measure.
Cancer patients assessment of their cancer trajectory and their assessment of the cooperation between their General Practitioner and the oncologist specialist.
|
7 month after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Illness Intrusiveness Rating Scale (IIRS)
Time Frame: 4 and 7 month after inclusion
|
Patient reported outcome measure.
Patients assessment of the cancer disease influence on their daily living.
|
4 and 7 month after inclusion
|
European Organisation for Research and Treatment of Cancer - Quality of Life questionnaire - Core 30 (EORTC QLQ C30)
Time Frame: 4 and 7 month after inclusion
|
Patient reported outcome measure.
Cancer patients assessment of their quality of life
|
4 and 7 month after inclusion
|
European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)
Time Frame: 4 and 7 month after inclusion
|
4 and 7 month after inclusion
|
|
Generalised Anxiety Disorder Assessment (GAD-7)
Time Frame: 4 and 7 month after inclusion
|
Patient reported outcome measure.
Screening tool and severity measure for generalised anxiety disorder
|
4 and 7 month after inclusion
|
Patient Health Questionnaire (PHQ-9)
Time Frame: 4 and 7 month after inclusion
|
Patient reported outcome measure.The questionnaire monitor the severity of depression and response to treatment.
|
4 and 7 month after inclusion
|
Oncologist assessment of a video consultation between the patient, General practitioner and oncologist.
Time Frame: Directly after the video consultation intervention
|
It measures the oncologist perception of the benefits with the video consultation intervention.
Only the intervention group
|
Directly after the video consultation intervention
|
General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.
Time Frame: Directly after the video consultation intervention
|
It measures the General Practitioners perception of the benefits with the video consultation intervention.
Only the intervention group.
|
Directly after the video consultation intervention
|
Patients assessment of a video consultation between the patient, General practitioner and oncologist.
Time Frame: Directly after the video consultation intervention
|
It measures the patients perception of the benefits with the video consultation intervention.Only the intervention group
|
Directly after the video consultation intervention
|
General Practitioner cancer trajectory assessment
Time Frame: 4 month after the inclusion of the patient.
|
The General Practitioners assessment of the cooperation between the primary and secondary care regarding af specific cancer patient.
|
4 month after the inclusion of the patient.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hansen DG, Trabjerg TB, Sisler JJ, Sondergaard J, Jensen LH. Cross-sectoral communication by bringing together patient with cancer, general practitioner and oncologist in a video-based consultation: a qualitative study of oncologists' and nurse specialists' perspectives. BMJ Open. 2021 May 5;11(5):e043038. doi: 10.1136/bmjopen-2020-043038.
- Trabjerg TB, Jensen LH, Sondergaard J, Sisler JJ, Hansen DG. Cross-sectoral video consultations in cancer care: perspectives of cancer patients, oncologists and general practitioners. Support Care Cancer. 2021 Jan;29(1):107-116. doi: 10.1007/s00520-020-05467-0. Epub 2020 Apr 21.
- Trabjerg TB, Jensen LH, Sondergaard J, Sisler JJ, Hansen DG. Improving continuity by bringing the cancer patient, general practitioner and oncologist together in a shared video-based consultation - protocol for a randomised controlled trial. BMC Fam Pract. 2019 Jun 25;20(1):86. doi: 10.1186/s12875-019-0978-8.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
August 1, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
March 3, 2016
First Submitted That Met QC Criteria
March 22, 2016
First Posted (Estimate)
March 23, 2016
Study Record Updates
Last Update Posted (Actual)
October 20, 2020
Last Update Submitted That Met QC Criteria
October 16, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Partnership-Project
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.
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