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Clinical Trials/NCT01709539
NCT01709539CompletedNot Applicable

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

Region Skane4 sites in 1 country388 target enrollmentStarted: October 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
388
Locations
4
Primary Endpoint
Time from first contact with primary care to information on diagnosis

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time from first contact with primary care to information on diagnosis

Time Frame: After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 37 days)

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.

Secondary Outcomes

  • 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)
  • 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))
  • 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))
  • Overall medication use(During the diagnosis process and for 24 months after diagnosis)
  • Time from information on diagnosis to initiation of treatment(From information on diagnosis to decision about treatment (anticipated to be up to 3 months))
  • Health care utilization(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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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