Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden

Study Overview
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Brief Summary
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The aim of this study is to evaluate a new cancer diagnosis center (Diagnostiskt Centrum, DC) in Kristianstad, Sweden. Patients aged ≥ 18 years who are suspected of having serious illness but who have no organ-specific symptoms will be referred to the DC for further investigation after preliminary assessment in primary care. The overall purpose of the study is to evaluate whether the DC meets its target time for diagnosing cancer. In addition, we will evaluate secondary issues, such as survival, to determine whether this pilot project merits extension to other parts of southern Sweden.

Detailed Description
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Diagnostiskt Centrum (DC), Sweden's first specialized cancer diagnosis center, was established at Kristianstad General Hospital in 2012 as a model for reducing the time taken to diagnose cancer in primary care patients with diffuse, non-organ specific symptoms. If it is successful, the DC model could be rolled out to other areas of Sweden. This study by the Center for Primary Health Care Research in Malmö, Sweden and Regionalt cancercentrum syd will investigate whether the DC process reduces the time from (1) the point when the patient first contacts his/her primary care center with symptoms to (2) the point when he/she is informed about his/her diagnosis (of cancer or another disease). This will be achieved by comparison with matched control patients with suspected cancer who will be referred to Helsingborg General Hospital for further investigation according to existing diagnostic procedures. Various outcome measures will be investigated, and patients' experiences of the DC process will be assessed using a tailored questionnaire. In addition, the DC model will be subjected to health economics analysis.

Official Title
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Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden

Conditions
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Cancer

Intervention / Treatment
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* Procedure: Diagnostiskt Centrum


Participation Criteria
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Eligibility Criteria
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Individuals in two cities in southern Sweden (Helsingborg and Kristianstad) who contact their primary care center because of diffuse, non-organ-specific symptoms Inclusion criteria: suspicion of cancer following preliminary investigation in primary care Exclusion criteria: (1) age < 18 years; and (2) inability to fill in the patient questionnaire

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostiskt Centrum<br>Investigation at the primary care center followed by further investigation at Diagnostiskt Centrum, Kristianstad General Hospital | Procedure: Diagnostiskt Centrum<br>* Patients who are suspected of having cancer after investigation at the primary care center will be referred to Diagnostiskt Centrum. Each patient who is referred to Diagnostiskt Centrum will undergo the following: (1) clinical chemistry/microbiology tests; (2) medical history; (3) objective clinical examination; and (4) taking of blood samples for analysis of biomarkers. If necessary, patients will also undergo the following: (5) additional laboratory tests; (6) biopsy; (7) X-ray of painful joints; (8) CT scan of the neck, thorax, abdomen, and/or pelvis; (9) mammography and gynecological examination; (10); gastroscopy and/or colonoscopy; and (11) further investigation (e.g., PET-CT scan).<br>* Other names: Cancer diagnosis center, Kristianstad General Hospital;|
| No Intervention: Existing diagnostic procedures<br>Investigation at the primary care center followed by further investigation at Helsingborg General Hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from first contact with primary care to information on diagnosis | The time from the point at which the patient first makes contact with his/her primary care center to the point when he/she is given his/her diagnosis. This comprises two elements: (1) investigation in primary care and (2) investigation at Diagnostiskt Centrum/Helsingborg General Hospital. These two elements will be investigated as secondary outcome measures. | After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 37 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from first contact with primary care to decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital |  | After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be 10-15 days) | 
| Time from decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital to information on diagnosis |  | After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 22 days) | 
| Survival after diagnosis of cancer or another serious disease |  | For up to 10 years after diagnosis | 
| Sick leave |  | During the diagnosis process and for 24 months after diagnosis | 
| Health care utilization |  | During the diagnosis process and for 24 months after diagnosis | 
| Overall medication use |  | During the diagnosis process and for 24 months after diagnosis | 
| Use of analgesics, antidepressants, and other psychotropic drugs |  | During the diagnosis process and for 24 months after diagnosis | 
| Time from information on diagnosis to decision about treatment |  | From information on diagnosis to decision about treatment (anticipated to be up to 2 months) | 
| Time from information on diagnosis to initiation of treatment |  | From information on diagnosis to decision about treatment (anticipated to be up to 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer diagnosis center, Time to diagnosis, Survival, Health economics, Biomarkers