QUEST: QUality of Life and Experiences of Sarcoma Trajectories (QUEST)

March 12, 2020 updated by: Radboud University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • NKI-AvL
        • Contact:
          • Vicky Soomers
      • Groningen, Netherlands
      • Leiden, Netherlands
        • Recruiting
        • LUMC
        • Contact:
          • Vicky Soomers
      • Nijmegen, Netherlands, 6525GA
      • Rotterdam, Netherlands
  • United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • Royal Orthopaedic Hospital
        • Contact:
          • Vicky Soomers
      • London, United Kingdom
        • Recruiting
        • Royal Marsden NHS Foundation Trust
        • Contact:
          • Vicky Soomers
      • Manchester, United Kingdom
        • Recruiting
        • The Christie NHS Foundation Trust
        • Contact:
          • Vicky Soomers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with sarcoma, see inclusion criteria

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Winette van der Graaf, Prof, MD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-3881

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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