Supportive Care Needs of Caregivers of People With Erdheim-Chester Disease and Other Histiocytic Diseases

A Study to Identify the Supportive Care Needs of Caregivers of Patients With Erdheim-Chester Disease and Other Histiocytic Diseases

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?

Study Overview

• Status: Recruiting
• Conditions: Supportive Care Needs of Caregivers
• Intervention / Treatment: Behavioral: online surveys

• Study Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

• Study Contact: Name: Eli Diamond, MD; Phone Number: 212-610-0243; Email: diamone1@mskcc.org
• Study Contact Backup: Name: Katherine Panageas, DrPH; Phone Number: 646-888-8237

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Principal Investigator: Eli Diamond, MD
      • Contact: Eli Diamond, MD; Phone Number: 212-610-0243
      • Contact: Katherine Panageas, DrPH; Phone Number: 646-888-8237

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supportive Care Needs of informal caregivers	measured by the McGill Quality of Life in Life Threatening Illness - Family Carer Version (QLLTI-FC)	3 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Eli Diamond, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Supportive care; Erdheim-Chester Disease; Other Histiocytic Diseases; 19-213
• Additional Relevant MeSH Terms: Lymphatic Diseases; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Erdheim-Chester Disease
• Other Study ID Numbers: 19-213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No