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

NCT05995834 | Unknown

• 1 other identifier: ISBUS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (5)

• Long list of candidate items for the scale (stage 1)

  completion of data analysis from a previous survey

  Sept 2023 - Nov 2023

• Completion of interviews (stage 2)

  completion of interviews by 10 patients from all recruiting sites

  Within 6 months from start (With this being a rare condition, data from all patients will be collected at various levels of treatment and time from diagnosis)

• Completion of questionnaire (stage 3)

  completion of questionnaire which includes extra questions about treatments, time of diagnosis. Completion of EQ-5D for external validity of PROM. NB: EQ-5D is the full name of the instrument and not an acronym.

  Within 9 months from start (With this being a rare condition, data from all patients will be collected at various levels of treatment and time from diagnosis). NB: Advisory comments noted.

• Completion of follow-up questionnaire (stage 4a)

  completion of follow-up questionnaire from Stage 3 by same patients who participated in Stage 3. Note: The full name of the scale will be discussed and confirmed. At the moment, the working title is Idiopathic Multicentric Castleman Disease Symptom Burden Scale (ISBUS).

  About 8 weeks after Stage 3 questionnaire. Note: Advisory comments noted.

• Completion of interviews (stage 4b)

  completion of interviews by 10 patients from all recruiting sites

  About 4 weeks after Stage 4a

Interventions

Research questions OTHER

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

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 patients diagnosed with idiopathic Multicentric Castleman Disease (iMCD).

You may qualify if:

• Diagnosis of idiopathic Multicentric Castleman Disease (iMCD)
• Adults (aged 18+ years)
• Fluent in English

You may not qualify if:

• No diagnosis of iMCD
• Children (aged \< 18 years)
• Not able to understand or communicate in English
• People lacking the capacity to consent

Sponsors & Collaborators

• RECORDATI GROUP: lead
• University of Sheffield (ScHARR): collaborator
• KMC Health Care: collaborator
• Castleman Disease Collaborative Network (CDCN): collaborator

Related Links

• example of registration of PROMs
• example of registration of PROMs
• example of registration of PROMs

MeSH Terms

Conditions

Multi-centric Castleman's Disease

Study Officials

• Anju Keetharuth, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

• Philip Powell, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anju Keetharuth, PhD

CONTACT

+44 (0) 114 222 0884; d.keetharuth@sheffield.ac.uk

Philip Powell, PhD

CONTACT

+44 (0) 114 222 0794; p.a.powell@sheffield.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 16, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share