Multiple MyelomaNCT04727294
MGUS, SMM, and MM Patient Experience With Coronavirus 19 (COVID-19) Survey
An observational study of Multiple Myeloma and Smoldering Multiple Myeloma, run by HealthTree Foundation at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with MGUS, smoldering myeloma, or multiple myeloma.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
HealthTree.org (Online)
Lehi, Utah, 84043
Nathan Sweeney, PhD, 800-709-1113, nathan@healthtree.org
Ana Sahagun, MS, 1-800-709-1113
About this study
Official title: 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.
- Conditions
- Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Coronavirus
- Being tested
- Questionnaire
- Keywords
- Questionnaire
- Medical subject headings
- Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Diagnosis and Treatment
Describe how patients diagnosed with COVID-19 were treated for the virus.
Measured: 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
Measured: Up to one year
Health and Fitness
Describe how COVID-19 impacted patient's health and fitness
Measured: 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.
Measured: Up to one year
Secondary outcomes (1)
Clinical Trial Familiarity
Describe how familiar patients are with multiple myeloma clinical trials.
Measured: Upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start22 Jan 2021
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthTree Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Nathan Sweeney, PhD, Study chair, HealthTree Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727294
- Sponsor's protocol ID
- MM/COVID-19 part II
- Status last verified
- Aug 2021
- First submitted
- 26 Jan 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Myeloma (SMM), and Multiple Myeloma Patient Experience With COVID-19 Survey
- ClinicalTrials.gov ID
- NCT04727294
- Acronym / sponsor ID
- MM/COVID-19 part II
- Conditions
- Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Coronavirus
- Keywords
- Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- HealthTree FoundationUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGUS, SMM, MM Patients or their Caregivers | – | Behavioral: QuestionnaireEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with MGUS, smoldering myeloma, or multiple myeloma.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireSeries of questions covering COVID-19 diagnosis and treatment, changes in myeloma treatment and care, clinical trial familiarity, health and fitness, and quality of life. | Behavioural | MGUS, SMM, MM Patients or their Caregivers |
Primary outcome
COVID-19 Diagnosis and Treatment
Time frame: Up to one year
Describe how patients diagnosed with COVID-19 were treated for the virus.
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
Health and Fitness
Time frame: Up to one year
Describe how COVID-19 impacted patient's health and fitness
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.
1 secondary outcome
Clinical Trial Familiarity
Time frame: Upon enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Multiple Myeloma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Sweeney, PhD study chair
HealthTree Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Smoldering Multiple Myeloma, run by HealthTree Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathan Sweeney, PhD (18007091113, nathan@healthtree.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Diagnosis and Treatment (time frame: Up to one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.