Clinical trial NCT01709539: Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden
Official title: Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer diagnosis center
Time to diagnosis
Survival
Health economics
Biomarkers
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time from first contact with primary care to information on diagnosis
timeFrame: After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 37 days)
Secondary outcomes:
measure: Time from first contact with primary care to decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital
timeFrame: After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be 10-15 days)
measure: Time from decision to refer to Diagnostiskt Centrum/Helsingborg General Hospital to information on diagnosis
timeFrame: After completion of investigation at Diagnostiskt Centrum/Helsingborg General Hospital (anticipated to be up to 22 days)
measure: Survival after diagnosis of cancer or another serious disease
timeFrame: For up to 10 years after diagnosis
measure: Sick leave
timeFrame: During the diagnosis process and for 24 months after diagnosis
measure: Health care utilization
timeFrame: During the diagnosis process and for 24 months after diagnosis
measure: Overall medication use
timeFrame: During the diagnosis process and for 24 months after diagnosis
measure: Use of analgesics, antidepressants, and other psychotropic drugs
timeFrame: During the diagnosis process and for 24 months after diagnosis
measure: Time from information on diagnosis to decision about treatment
timeFrame: From information on diagnosis to decision about treatment (anticipated to be up to 2 months)
measure: Time from information on diagnosis to initiation of treatment
timeFrame: From information on diagnosis to decision about treatment (anticipated to be up to 3 months)
Other outcomes:
measure: Serum inflammatory biomarker levels
timeFrame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
measure: Serum epidermal growth factor (EGF) receptor levels
timeFrame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
measure: Plasma microRNA levels
timeFrame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
measure: Telomere length
timeFrame: During the diagnosis process (anticipated to be up to 37 days after first contact with primary care)
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg General Hospital
state: Skåne
city: Kristianstad
country: Sweden
facility: Diagnostiskt Centrum, Kristianstad General Hospital
state: Skåne
Study officials:
affiliation: Center for Primary Health Care Research, Malmö, Sweden
name: Jan Sundquist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundquist J, Palmer K, Ryden S, Savblom C, Ji J, Stenman E. Time Intervals Under the Lens at Sweden's First Diagnostic Center for Primary Care Patients With Nonspecific Symptoms of Cancer. A Comparison With Matched Control Patients. Front Oncol. 2020 Nov 30;10:561379. doi: 10.3389/fonc.2020.561379. eCollection 2020.