NCT03990428

Brief Summary

This study is being done to answer the following question: What are the supportive care needs of informal caregivers of people with Erdheim-Chester disease and other histiocytic diseases?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2019Jun 2026

First Submitted

Initial submission to the registry

June 14, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

7 years

First QC Date

June 14, 2019

Last Update Submit

September 10, 2025

Conditions

Keywords

Supportive careErdheim-Chester DiseaseOther Histiocytic Diseases19-213

Outcome Measures

Primary Outcomes (1)

  • Supportive Care Needs of informal caregivers

    measured by the McGill Quality of Life in Life Threatening Illness - Family Carer Version (QLLTI-FC)

    3 years

Study Arms (1)

Caregivers of Patients

This is an observational study of informal caregivers (ICs) of patients with Erdheim-Chester Disease (ECD) and other histiocytic diseases. That will collect data cross-sectionally, at a single time point. Caregiver-reported data will be completed in the form of online surveys by the participants themselves using the Research Electronic Data Capture Platform \[RedCAP\] platform.

Behavioral: online surveys

Interventions

online surveysBEHAVIORAL

Survey data about supportive care needs, mood, and the experience of IC's finding meaning and purpose in the caregiving experience.

Caregivers of Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A target sample of 120 ICs of patients with Erdheim-Chester Disease will be enrolled in this study. Additionally, a target sample of 50 ICs of patients with other histiocytic disorders will be enrolled.

You may qualify if:

  • Self-identified informal caregiver (family member or friend who provides unpaid support) for a patient with Erdheim-Chester Disease (or LCH, RDD, or JXG for the exploratory aim).
  • Proficiency to complete study assessments in English, evaluated at the time of consent.
  • Age 18 or over.

You may not qualify if:

  • Participant unwilling to sign consent.
  • Participant unable to complete web-based assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Erdheim-Chester Disease

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Eli Diamond, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eli Diamond, MD

CONTACT

Katherine Panageas, DRPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 19, 2019

Study Start

June 14, 2019

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Shared Documents
SAP, ICF

Locations