Clinical trial NCT02716168: Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy
Official title: Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
tele-health
Shared care
Continuity
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: National Research Center of Cancer Rehabilitation
name: Research Unit of General Practice, Odense
name: Vejle Hospital
name: Region of Southern Denmark
name: Odense Patient Data Explorative Network
First posted: 2016-03-23
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Shared Care questionnaire
timeFrame: 7 month after inclusion
Secondary outcomes:
measure: Illness Intrusiveness Rating Scale (IIRS)
timeFrame: 4 and 7 month after inclusion
measure: European Organisation for Research and Treatment of Cancer - Quality of Life questionnaire - Core 30 (EORTC QLQ C30)
timeFrame: 4 and 7 month after inclusion
measure: European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)
timeFrame: 4 and 7 month after inclusion
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: 4 and 7 month after inclusion
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 4 and 7 month after inclusion
measure: Oncologist assessment of a video consultation between the patient, General practitioner and oncologist.
timeFrame: Directly after the video consultation intervention
measure: General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.
timeFrame: Directly after the video consultation intervention
measure: Patients assessment of a video consultation between the patient, General practitioner and oncologist.
timeFrame: Directly after the video consultation intervention
measure: General Practitioner cancer trajectory assessment
timeFrame: 4 month after the inclusion of the patient.
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital, Region of Southern Denmark
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.