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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04727294
Other study ID # MM/COVID-19 part II
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 22, 2021
Est. completion date December 2021

Study information

Verified date August 2021
Source HealthTree Foundation
Contact Nathan Sweeney, PhD
Phone 18007091113
Email nathan@healthtree.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to examine how patients with multiple myeloma (MM) have been impacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. The study will use a questionnaire to further understand how patients are being affected and gather information in order to track the long-term effects of the coronavirus. The scope of the questionnaire will include, COVID-19 diagnosis and treatment, changes in myeloma treatment and care, clinical trial familiarity, health and fitness, and quality of life. This questionnaire is a follow-on to the "MM and COVID-19" questionnaire.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date December 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (greater than 18 years) diagnosed with MGUS, smoldering myeloma, and multiple myeloma. - Access to a computer or electronic device with internet access, or phone - Willing to create a patient profile on the HealthTree Cure Hub For Multiple Myeloma - Willing to give electronically-signed consent - Ability to read questions in English

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaire
Series of questions covering COVID-19 diagnosis and treatment, changes in myeloma treatment and care, clinical trial familiarity, health and fitness, and quality of life.

Locations

Country Name City State
United States HealthTree.org (Online) Lehi Utah

Sponsors (2)

Lead Sponsor Collaborator
HealthTree Foundation GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary COVID-19 Diagnosis and Treatment Describe how patients diagnosed with COVID-19 were treated for the virus. Up to one year
Primary Changes to Myeloma Treatment and Care Describe which treatments were changed and how care was affected as a result of COVID-19 Up to one year
Primary Health and Fitness Describe how COVID-19 impacted patient's health and fitness Up to one year
Primary Quality of Life (QOL) Distress Screening tool Describe how patients rate their level of concern on psychosocial, practical, and physical needs during the COVID-19 pandemic using the Cancer Support Community's CancerSupportSource distress screening tool. Up to one year
Secondary Clinical Trial Familiarity Describe how familiar patients are with multiple myeloma clinical trials. Upon enrollment
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