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

NCT04727294 | Unknown

• 1 other identifier: MM/COVID-19 part II
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Coronavirus

Keywords

Questionnaire

Outcome Measures

Primary Outcomes (4)

• COVID-19 Diagnosis and Treatment

  Describe how patients diagnosed with COVID-19 were treated for the virus.

  Up to one year

• 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

• Health and Fitness

  Describe how COVID-19 impacted patient's health and fitness

  Up to one year

• 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 Outcomes (1)

• Clinical Trial Familiarity

  Upon enrollment

Study Arms (1)

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

Interventions

Questionnaire BEHAVIORAL

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.

MGUS, SMM, MM Patients or their Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• HealthTree Foundation: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

HealthTree.org (Online)

Lehi, Utah, 84043, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Coronavirus Infections

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Hypergammaglobulinemia; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nathan Sweeney, PhD

  HealthTree Foundation

  STUDY CHAIR

Central Study Contacts

Nathan Sweeney, PhD

CONTACT

18007091113; nathan@healthtree.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 27, 2021
• Study Start: January 22, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Access Criteria: Visit the HealthTree Foundation's online patient portal: HealthTree Cure Hub For Multiple Myeloma

Locations

US (1)