EORTC Quality of Life Measurement Strategies in Progressive Cancer

April 28, 2026 updated by: Galina Velikova, University of Leeds

Measurement Strategies for Assessment of Health-related Quality of Life Outcomes in Cancer Patients With Progressive Disease

Rationale: Health-related quality of life (HRQOL) in people diagnosed with cancer is of increasing interest as an endpoint in clinical care and research. It helps keep track of patients' functioning and wellbeing, and informs the net clinical benefit of treatment. However, gathering HRQOL information becomes increasingly harder when patients experience disease progression. Therefore we need to develop measurement strategies of HRQOL within the progressive disease setting. Objective: The overall aim of the project is to develop recommendations to optimise the measurement and analysis of HRQOL outcomes of cancer patients within the progressive disease setting. The aim of this sub-study is to identify the preferences of patients, their carers as proxies, and health-care professionals (HCPs) about the research objectives, how often and how we should assess HRQOL, and how we might limit dropout over time.

Sub-study design: An international, multi-centre study using semi-structured interviews.

Procedures: Across Europe, we aim to interview adult people diagnosed with cancer who experience progressive disease (N=30), their carers as proxies (N=30), and HCPs involved in cancer care and/or research (N=15). The UK site will aim to recruit a maximum of 10 patients and 10 proxies. Patients and carers will be interviewed twice to evaluate whether preferences change over time. Study outcomes: Findings can help in optimising the measurement and analysis of HRQOL outcomes of cancer patients in the progressive disease setting. This will help to better inform both clinical decision-making and regulatory processes.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult (> 18 years of age) attending ST James University Hospital in Leeds

Description

Inclusion Criteria:

PATIENT- Adult (> 18 years of age)

  • Histologically proven or radiologically diagnosed cancer
  • Clinical and/or radiological progressive disease according to RECIST criteria
  • Poor prognosis, i.e. expected survival time <3 years according to the treating physician PROXIES - Adult (> 18 years of age)
  • Partner, relative or close friend of a patient who is eligible according to the criteria specified above

Exclusion Criteria:

  • Participants without understanding of the official language of the country in which they live
  • Participants with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper providing informed consent for research participation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimise the measurement and analysis of HRQOL outcomes
Time Frame: 3 months
Interview adult people diagnosed with cancer who experience progressive disease (N=10) and their carers as proxies (N=10). Patients and carers will be interviewed twice to evaluate if preferences change over time. This will develop recommendations to optimise the measurement and analysis of HRQOL outcomes of cancer patients within the progressive disease setting.
3 months

Collaborators and Investigators

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

Sponsor

University of Leeds

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)

June 2, 2025

Primary Completion (Actual)

January 19, 2026

Study Completion (Actual)

January 19, 2026

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS333361

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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