QUEST: QUality of Life and Experiences of Sarcoma Trajectories

Quality of Life Clinical Trial

— QUEST  

Official title:

QUEST: QUality of Life and Experiences of Sarcoma Trajectories

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03441906
• Other study ID #: 2017-3881
• Status: Recruiting
• Start date: February 15, 2018
• Est. completion date: February 2021

Study information

• Verified date: March 2019
• Source: Radboud University
• Contact: Vicky Soomers, MSc, MD
• Phone: 0031243618800
• Email: Vicky.Soomers[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: February 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Care Needs
• Diagnostic Interval
• Diagnostic Pathway
• Quality of Life
• Sarcoma

Locations

Country	Name	City	State
Netherlands	NKI-AVL	Amsterdam
Netherlands	UMCG	Groningen
Netherlands	LUMC	Leiden
Netherlands	Radboudumc	Nijmegen
Netherlands	Erasmus medical centre	Rotterdam
United Kingdom	Royal Orthopaedic Hospital	Birmingham
United Kingdom	Royal Marsden NHS Foundation Trust	London
United Kingdom	The Christie NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

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