Development of a Research Infrastructure for Understanding and Addressing Multiple Myeloma Disparities (MEDULLA)
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|ClinicalTrials.gov Identifier: NCT04314752|
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : October 19, 2020
|Condition or disease|
Eligible patients will include African Americans, Latinos and AANHPIs who were diagnosed with a first primary, pathologically confirmed MM within the previous five years and who were at least 21 years of age at the time of diagnosis. Investigators will also include, as a comparison group, non-Hispanic White patients. Patients must have been diagnosed in one of the 48 counties of California. Patients must be alive at the time of study and able to provide informed consent. The research team will not include those who are unable to consent, pregnant women, or prisoners.
Initially, investigators will randomly select 100 eligible patients from each race/ethnicity mentioned above to participate in the pilot study. Once the pilot is completed, the investigators will aim to contact all eligible patients reported to the Cancer Registry of Greater California (CRGC) until 2024.
Drs. Carvajal-Carmona and Cress have coordinated with MEDULLA investigators and CRGC research staff to develop a questionnaire for racial/ethnic minorities with Multiple Myeloma. The survey focuses on demographics, risk factors, cancer treatment, quality of life, and social determinants of health. All survey items are adapted from previously tested and validated surveys. The survey is expected to take approximately 30-45 minutes to complete.
CRGC staff, under Dr. Cress supervision, will identify eligible participants using the criteria described above based on diagnostic information in the CRGC database. The research team will be following California Cancer Registry policies and procedures for release of data. CRGC staff will extract patients contact information from the registry and will provide this information to research staff at UC Davis, who will work under Dr. Carvajal-Carmona's supervision.
The UC Davis Research team will initially mail each eligible participants a postcard and a survey study packet that will include: 1) Simple instruction sheet 2) An introductory letter that details the study 3) Information sheet that details on informed consent 4) Survey instruction sheet 5) A paper copy of the survey 5) Incentive selection sheet and option to continue to the second part of study 6) Brochures about the cancer registry and the UC Davis Comprehensive Cancer Center, and return pre-paid envelope.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||400 participants|
|Target Follow-Up Duration:||4 Years|
|Official Title:||Development of a Research Infrastructure for Understanding and Addressing Multiple Myeloma Disparities|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||November 30, 2024|
|Estimated Study Completion Date :||November 30, 2024|
- Review the response rate of mailed out surveys, compared by race/ethnicity and disease status [ Time Frame: 2024 ]Response Rate in percentage
- Response rate for saliva kits compared to survey response and determine if there is a disparity in participation between race/ethnic groups [ Time Frame: 2024 ]Response Rates in percentage
Biospecimen Retention: Samples With DNA
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): NCT04314752
|Contact: Luis Carvajal-Carmona, PhDemail@example.com|
|Contact: Fabian Perez, MPHfirstname.lastname@example.org|
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Luis Carvajal-Carmona, PhD 530-752-9654 email@example.com|
|Contact: Fabian Perez, MPH 9167344560 firstname.lastname@example.org|
|Principal Investigator:||Luis Carvajal-Carmona, PhD||University of California, Davis|
|Principal Investigator:||Rosemary Cress, DrPh MPH||Cancer Registry of California|