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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04727294
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : August 4, 2021
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
HealthTree Foundation

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Multiple Myeloma Smoldering Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance Coronavirus Behavioral: Questionnaire

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Myeloma (SMM), and Multiple Myeloma Patient Experience With COVID-19 Survey
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. COVID-19 Diagnosis and Treatment [ Time Frame: Up to one year ]
    Describe how patients diagnosed with COVID-19 were treated for the virus.

  2. 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

  3. Health and Fitness [ Time Frame: Up to one year ]
    Describe how COVID-19 impacted patient's health and fitness

  4. 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.


Secondary Outcome Measures :
  1. Clinical Trial Familiarity [ Time Frame: Upon enrollment ]
    Describe how familiar patients are with multiple myeloma clinical trials.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with MGUS, smoldering myeloma, or multiple myeloma.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727294


Contacts
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Contact: Nathan Sweeney, PhD 18007091113 nathan@healthtree.org

Locations
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United States, Utah
HealthTree.org (Online) Recruiting
Lehi, Utah, United States, 84043
Contact: Nathan Sweeney, PhD    800-709-1113    nathan@healthtree.org   
Contact: Ana Sahagun, MS    1-800-709-1113      
Sponsors and Collaborators
HealthTree Foundation
GlaxoSmithKline
Investigators
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Study Chair: Nathan Sweeney, PhD HealthTree Foundation
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: HealthTree Foundation
ClinicalTrials.gov Identifier: NCT04727294    
Other Study ID Numbers: MM/COVID-19 part II
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: Visit the HealthTree Foundation's online patient portal: HealthTree Cure Hub For Multiple Myeloma
URL: http://healthtree.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthTree Foundation:
Questionnaire
Additional relevant MeSH terms:
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Coronavirus Infections
Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
 Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections
Hypergammaglobulinemia
Precancerous Conditions