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

August 2, 2021 updated by: HealthTree Foundation

Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Myeloma (SMM), and Multiple Myeloma Patient Experience With COVID-19 Survey

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Lehi, Utah, United States, 84043
        • Recruiting
        • HealthTree.org (Online)
        • Contact:
        • Contact:
          • Ana Sahagun, MS
          • Phone Number: 1-800-709-1113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with MGUS, smoldering myeloma, or multiple myeloma.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MGUS, SMM, MM Patients or their Caregivers

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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Trial Familiarity
Time Frame: Upon enrollment
Describe how familiar patients are with multiple myeloma clinical trials.
Upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthTree Foundation

Collaborators

GlaxoSmithKline

Investigators

  • Study Chair: Nathan Sweeney, PhD, HealthTree Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM/COVID-19 part II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The HealthTree foundation values responsible and ethical sharing of data from clinical trials. De-identified patient responses to the questionnaire will be aggregated and shared back with the patient. Additionally, portions of the de-identified results will be shared with the research community through publications (abstracts, reports, manuscripts).

IPD Sharing Access Criteria

Visit the HealthTree Foundation's online patient portal: HealthTree Cure Hub For Multiple Myeloma

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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