Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy

Cancer Clinical Trial

— PSP  

Official title:

Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716168
• Other study ID #: Partnership-Project
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: August 2020

Study information

• Verified date: October 2020
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Shared video consultation between patient, general practitioner and oncologist
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.

Locations

Country	Name	City	State
Denmark	Department of Oncology, Vejle Hospital, Region of Southern Denmark	Vejle

Sponsors (6)

Lead Sponsor	Collaborator
University of Southern Denmark	National Research Center of Cancer Rehabilitation, Odense Patient Data Explorative Network, Region of Southern Denmark, Research Unit of General Practice, Odense, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 month after inclusion
Secondary	Illness Intrusiveness Rating Scale (IIRS)	Patient reported outcome measure. Patients assessment of the cancer disease influence on their daily living.	4 and 7 month after inclusion
Secondary	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	4 and 7 month after inclusion
Secondary	European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)		4 and 7 month after inclusion
Secondary	Generalised Anxiety Disorder Assessment (GAD-7)	Patient reported outcome measure. Screening tool and severity measure for generalised anxiety disorder	4 and 7 month after inclusion
Secondary	Patient Health Questionnaire (PHQ-9)	Patient reported outcome measure.The questionnaire monitor the severity of depression and response to treatment.	4 and 7 month after inclusion
Secondary	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	Directly after the video consultation intervention
Secondary	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.	Directly after the video consultation intervention
Secondary	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	Directly after the video consultation intervention
Secondary	General Practitioner cancer trajectory assessment	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.

External Links

•   Project webpage (in Danish)