CancerNCT06842654
EORTC Quality of Life Measurement Strategies in Progressive Cancer
An observational study of Cancer, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2025to 19 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (> 18 years of age) attending ST James University Hospital in Leeds
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start2 Jun 2025
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galina Velikova, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842654
- Sponsor's protocol ID
- IRAS333361
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement Strategies for Assessment of Health-related Quality of Life Outcomes in Cancer Patients With Progressive Disease
- ClinicalTrials.gov ID
- NCT06842654
- Acronym / sponsor ID
- IRAS333361
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (> 18 years of age) attending ST James University Hospital in Leeds
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimise the measurement and analysis of HRQOL outcomes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.