MGUS, SMM, and MM Patient Experience With Coronavirus 19 (COVID-19) Survey

• Conditions: Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma; Coronavirus
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT04727294
• Lead Sponsor: HealthTree Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-22
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-04
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MGUS, SMM, MM Patients or their Caregivers	Questionnaire	Eligible participants will be asked to create a free patient profile on the HealthTree Cure Hub (www.healthtree.org) or use their existing patient profile. The creation of a HealthTree Cure Hub patient profile will serve as a screen for eligibility. Patients will complete a one-time questionnaire found on the HealthTree Cure Hub. Telephone assistance can be provided as needed. The questionnaire will take 20-30 minutes to complete.

Primary Outcome Measures

Name	Time	Method
Quality of Life (QOL) Distress Screening tool	Up to one year	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.
COVID-19 Diagnosis and Treatment	Up to one year	Describe how patients diagnosed with COVID-19 were treated for the virus.
Changes to Myeloma Treatment and Care	Up to one year	Describe which treatments were changed and how care was affected as a result of COVID-19
Health and Fitness	Up to one year	Describe how COVID-19 impacted patient's health and fitness

Secondary Outcome Measures

Name	Time	Method
Clinical Trial Familiarity	Upon enrollment	Describe how familiar patients are with multiple myeloma clinical trials.

Trial Locations

Locations (1)

HealthTree.org (Online); 🇺🇸 Lehi, Utah, United States