QUEST: QUality of Life and Experiences of Sarcoma Trajectories

Study Overview
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Brief Summary
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Background: The prognosis of patients with rare cancers in general and sarcomas in particular suffers from delay in diagnosis. Routes to diagnosis for sarcoma need to be quicker and more streamlined, but have neither been studied in detail in larger numbers before, nor in a direct comparison between two countries with different health systems. Comprehensive assessment of diagnostic delays and its determinants, including demographic, clinical, psychosocial and health care system factors, is necessary to improve referral pathways and come to best practice and patient reported outcomes for sarcoma patients. Research questions to be answered: This study aims to quantify diagnostic delay (including patient, general practitioner and system delay) and evaluates routes to diagnosis and referral to sarcoma expert centres in the Netherlands and England; to comprehensively evaluate risk factors of diagnostic delay; determine the association between diagnostic delay and outcomes (health-related quality of life, quality-adjusted life years, patient satisfaction, TNM classification, time to local/distant relapse and overall survival); and to assess differences between both countries. This should lead to advices about faster referral where possible.

Detailed Description
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The researchers will conduct a longitudinal cohort study among all sarcoma patients (≥18 years of age) that will be newly diagnosed in 1.5 years period from October 1st 2017 to March 30st 2019 in one of the participating study centers (5 centers in The Netherlands, 3 centers in England). Patients will be invited before the start of treatment (with a two months eligibility window) and receive a questionnaire on diagnostic delay, risk factors and patient-reported outcomes. The questionnaire on patient-reported outcomes will be completed again 3 months, 6 months, 1-year and 2 years later. Data collection will be done within PROFILES, an international registry for cancer patient reported outcomes (www.profilesregistry.nl). Clinical data will be collected through cancer registries and the junior investigator will collect extra data from patients' records.

Official Title
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QUEST: QUality of Life and Experiences of Sarcoma Trajectories

Conditions
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Quality of Life, Sarcoma, Diagnostic Interval, Diagnostic Pathway, Care Needs

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at diagnosis ≥ 18 years Diagnosis of sarcoma (histology confirmed by sarcoma histopathologist; according to ICD-10-GM codes C40 and C41 for bone sarcoma and C49 for soft-tissue sarcoma) Able to communicate in English (or Dutch) Mental capacity to provide informed consent and to participate in the study (as determined by the referring health care professional) Patients must be able to complete questionnaires themselves Patients must be under treatment or follow-up at one of the participating hospitals. Exclusion Criteria: Too ill to complete questionnaires (according to advice from (former) treating specialist) Patients with desmoids fibromatosis will be excluded because of the non-malignancy of the disease; and patients with gastrointestinal stromal tumours (GIST; ICD-10-GM codes C15-20, C26, C48 and C80) will be excluded.

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Health-related quality of life | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic interval | Time to diagnosis | Relationship between diagnostic interval and quality of life at baseline | 
| Factors influencing diagnostic interval | Risk factors to experience a long diagnostic interval | At baseline | 
| QALY | Quality adjusted life years | Baseline | 
| Psychologic impact | several measures will be taken into account, such as HADS etc | 2 years | 
| Change in quality of life | Change in QoL throughout follow up | 2 years | 
| PFS | progression free survival | through study completion, an average of 2 years | 
| OS | Overall survival | Through study completion, an average of 2 years | 
| Change in QALY | Quality adjusted life years | Change from baseline throughout follow-up of 2 years |