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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Shared video consultation between patient, general practitioner and oncologist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video consultation<br>Video consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment | Other: Shared video consultation between patient, general practitioner and oncologist<br>* 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.<br>|
| No Intervention: usual care<br>Usual care. The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25) |  | 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 | 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. | 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 | 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. | 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 | 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. | 4 month after the inclusion of the patient. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, tele-health, Shared care, Continuity