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The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting

NCT05721365 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 142

Last updated 2023-06-07

No results posted yet for this study

Summary

The goals of this observational study is to

1. To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology
2. To develop guidelines/recommendations for the use of PROMs in ACT trials

Participants 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.

Conditions

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • The Christie NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Fiona Thistlethwaite, PhD · The Christie NHS Foundation Trust

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05721365 on ClinicalTrials.gov