CancerPSPNCT02716168
Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy
A study testing Shared video consultation between patient, general practitioner and oncologist in people with Cancer, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Shared video consultation between patient, general practitioner and oncologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteDenmark
- Study dates
- May 2016to Aug 2020
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Vejle Hospital, Region of Southern Denmark
Vejle, 7100
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- Shared video consultation between patient, general practitioner and oncologist
- Keywords
- Cancer, tele-health, Shared care, Continuity
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared video consultation between patient, general practitioner and oncologistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Video consultation | Experimental | Video consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment Receives: Other: Shared video consultation between patient, general practitioner and oncologist |
| usual care | No intervention | Usual care. The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Care questionnaire
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.
Measured: 7 month after inclusion
Secondary outcomes (9)
Illness Intrusiveness Rating Scale (IIRS)
Patient reported outcome measure. Patients assessment of the cancer disease influence on their daily living.
Measured: 4 and 7 month after inclusion
European Organisation for Research and Treatment of Cancer - Quality of Life questionnaire - Core 30 (EORTC QLQ C30)
Patient reported outcome measure. Cancer patients assessment of their quality of life
Measured: 4 and 7 month after inclusion
European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)
Measured: 4 and 7 month after inclusion
Generalised Anxiety Disorder Assessment (GAD-7)
Patient reported outcome measure. Screening tool and severity measure for generalised anxiety disorder
Measured: 4 and 7 month after inclusion
Patient Health Questionnaire (PHQ-9)
Patient reported outcome measure.The questionnaire monitor the severity of depression and response to treatment.
Measured: 4 and 7 month after inclusion
Oncologist assessment of a video consultation between the patient, General practitioner and oncologist.
It measures the oncologist perception of the benefits with the video consultation intervention. Only the intervention group
Measured: Directly after the video consultation intervention
General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.
It measures the General Practitioners perception of the benefits with the video consultation intervention. Only the intervention group.
Measured: Directly after the video consultation intervention
Patients assessment of a video consultation between the patient, General practitioner and oncologist.
It measures the patients perception of the benefits with the video consultation intervention.Only the intervention group
Measured: Directly after the video consultation intervention
General Practitioner cancer trajectory assessment
The General Practitioners assessment of the cooperation between the primary and secondary care regarding af specific cancer patient.
Measured: 4 month after the inclusion of the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Center of Cancer Rehabilitation, Research Unit of General Practice, Odense, Vejle Hospital, Region of Southern Denmark, Odense Patient Data Explorative Network
- Responsible party
- Principal investigator, Theis Trabjerg, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716168
- Sponsor's protocol ID
- Partnership-Project
- Acronym
- PSP
- Status last verified
- Oct 2020
- First submitted
- 3 Mar 2016
- Last updated
- 20 Oct 2020
- Results posted
- No
Publications
Baygi F, Trabjerg TB, Jensen LH, Munch Storsveen M, Wehberg S, Sondergaard J, Gilsa Hansen D. Impact of Cross-Sectoral Video Consultation on Perceived Care Coordination and Information Satisfaction in Cancer Care: Randomized Controlled Trial. JMIR Form Res. 2025 Dec 31;9:e76910. doi: 10.2196/76910.
PubMed 41474977Hansen 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.
PubMed 33952540Trabjerg 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.
PubMed 32318872Trabjerg 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.
PubMed 31238886
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02716168
- Acronym / sponsor ID
- PSP / Partnership-Project
- Conditions
- Cancer
- Keywords
- Cancer, tele-health, Shared care, Continuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- National Research Center of Cancer Rehabilitation, Research Unit of General Practice, Odense, Vejle Hospital, Region of Southern Denmark, Odense Patient Data Explorative Network
- Study start
- May 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video consultation | Experimental | Other: Shared video consultation between patient, general practitioner and oncologistVideo consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment |
| usual care | No intervention | –Usual care. The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared video consultation between patient, general practitioner and oncologistAt 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. | Other | Video consultation |
Primary outcome
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.
9 secondary outcomes
Illness Intrusiveness Rating Scale (IIRS)
Time frame: 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
European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)
Time frame: 4 and 7 month after inclusion
Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: 4 and 7 month after inclusion
Patient Health Questionnaire (PHQ-9)
Time frame: 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
General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.
Time frame: 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
General Practitioner cancer trajectory assessment
Time frame: 4 month after the inclusion of the patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Derived from this study: PubMed 41474977Baygi F, Trabjerg TB, Jensen LH, Munch Storsveen M, Wehberg S, Sondergaard J, Gilsa Hansen D. Impact of Cross-Sectoral Video Consultation on Perceived Care Coordination and Information Satisfaction in Cancer Care: Randomized Controlled Trial. JMIR Form Res. 2025 Dec 31;9:e76910. doi: 10.2196/76910.
- Derived from this study: PubMed 33952540Hansen 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.
- Derived from this study: PubMed 32318872Trabjerg 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.
- Derived from this study: PubMed 31238886Trabjerg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared video consultation between patient, general practitioner and oncologist in people with Cancer, run by University of Southern Denmark at 1 site in Denmark.
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 6 inclusion and 1 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Shared Care questionnaire (time frame: 7 month after inclusion). 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 NCT02716168, which also lists 4 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 20 Oct 2020.