EORTC Quality of Life Measurement Strategies in Progressive Cancer

NCT06842654 | Completed

• 1 other identifier: IRAS333361
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Optimise the measurement and analysis of HRQOL outcomes

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

St James Hospital

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Galina Velikova

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: June 2, 2025
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

GB (1)