QUEST: QUality of Life and Experiences of Sarcoma Trajectories

NCT ID: NCT03441906

Last Updated: 2020-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-15

Study Completion Date

2021-02-28

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.

Conditions

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Quality of Life Sarcoma Diagnostic Interval Diagnostic Pathway Care Needs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Winette van der Graaf, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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NKI-AVL

Amsterdam, , Netherlands

Site Status RECRUITING

UMCG

Groningen, , Netherlands

Site Status RECRUITING

LUMC

Leiden, , Netherlands

Site Status RECRUITING

Radboudumc

Nijmegen, , Netherlands

Site Status RECRUITING

Erasmus medical centre

Rotterdam, , Netherlands

Site Status RECRUITING

Royal Orthopaedic Hospital

Birmingham, , United Kingdom

Site Status RECRUITING

Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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Netherlands United Kingdom

Central Contacts

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Vicky Soomers, MSc, MD

Role: CONTACT

0031243618800

Facility Contacts

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Vicky Soomers

Role: primary

Vicky Soomers

Role: primary

0031243618800

Vicky Soomers

Role: primary

Vicky Soomers, MSc, MD

Role: primary

0243618800

Vicky Soomers

Role: primary

0031243618800

Vicky Soomers

Role: primary

Vicky Soomers

Role: primary

Vicky Soomers

Role: primary

References

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Soomers V, Desar IM, van de Poll-Franse LV, Husson O, van der Graaf WT. Quality of life and experiences of sarcoma trajectories (the QUEST study): protocol for an international observational cohort study on diagnostic pathways of sarcoma patients. BMJ Open. 2020 Oct 26;10(10):e039309. doi: 10.1136/bmjopen-2020-039309.

Reference Type DERIVED
PMID: 33109665 (View on PubMed)

Other Identifiers

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2017-3881

Identifier Type: -

Identifier Source: org_study_id

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