MedTrace Logo

Producing a Novel Symptom Burden Scale for People Living With Idiopathic Multicentric Castleman Disease (ISBUS)

NCT05995834 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-08-22

No results posted yet for this study

Summary

Development, validation of a novel symptom burden scale to assess and quantify the burden experienced by people living with Idiopathic Multicentric Castleman Disease (iMCD).

Conditions

  • Idiopathic Multicentric Castleman's Disease

Interventions

OTHER

Research questions

Stage 1: Secondary analysis of a previous international survey to identify items Stage 2: Cognitive debriefing interviews with about 10 people living with iMCD to assess the content validity of the items Stage 3: Completion of questionnaire to finalise scale Stage 4a: Re-administering of follow-up questionnaire to Stage 3 patients to assess minimally important clinical difference. Test-retest will be calculated only in patients exhibiting no change. Stage 4b: Qualitative interviews with a subset of participants from Stages and 4 to help with interpretation of meaningful difference from their perspective

Sponsors & Collaborators

  • University of Sheffield (ScHARR)

    collaborator UNKNOWN

  • KMC Health Care

    collaborator UNKNOWN

  • Castleman Disease Collaborative Network (CDCN)

    collaborator UNKNOWN

  • RECORDATI GROUP

    lead INDUSTRY

Principal Investigators

  • Anju Keetharuth, PhD · University of Sheffield

  • Philip Powell, PhD · University of Sheffield

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2024-12-31
Completion
2024-12-31

More Related Trials

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 NCT05995834 on ClinicalTrials.gov