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NCT05721365
The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting
Conditions: Cancer
Sex: All
Ages: 16 Years – N/A
Enrollment: 142
Sponsor: The Christie NHS Foundation Trust
Summary
The goals of this observational study is toTo develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatologyTo develop guidelines/recommendations for the use of PROMs in ACT trialsParticipants will be recruited in four separate stages:Stage 1: Semi-structured interviews to generate PROM items.
Stage 2: Cognitive interviews to ensure that all items are clear and easily understood.Stage 3: Initial pilot of the draft PROM to enable item reduction and refinement.Stage 4: Pilot of final PROM to assess acceptability in a clinical setting.
Eligibility Criteria
Inclusion Criteria:Patients who are enrolled on Adoptive Cell Therapy (ACT) trialAged over 16 (no upper age limit)Ability to understand and communicate in the English languageAble to provide written informed consentExclusion Criteria:Aged under 16Unable to understand and communicate in the English languageUnable to provide written informed consent
Source: ClinicalTrials.gov (NCT05721365). StuddyBuddy aggregates publicly available trial information.