Clinical trial NCT05831358: Early Detection of Multiple Myeloma to Fight Cancer Disparities: A Screening and Patient Navigation Program
Official title: Early Detection of Multiple Myeloma to Fight Cancer Disparities: A Screening and Patient Navigation Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 201
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Not a randomized trial; use of convenience sampling.
Primary purpose: SCREENING

Brief summary: This project will pilot the expansion of the existing Taussig Outreach Program's community outreach and patient navigation model to study the multiple myeloma (MM) screening program. This involves analyzing community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This study also aims to gauge the current and general understanding of MM. This study seeks to recruit participants in the pilot screening program to promote early detection. Participants who have abnormal results will receive patient navigation for further diagnostics and testing.

Detailed description: Multiple Myeloma (MM) is a hematologic cancer of antibody-producing plasma cells. Multiple Myeloma is always preceded by a pre-malignant condition called monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma. Despite multiple therapeutic advances, there remains no cure for multiple myeloma. The disease is treated and monitored throughout a person's lifetime. This is why screening for early detection of this disease is important; however, MGUS and smoldering multiple myeloma are only diagnosed when they are found incidentally on labs during tests for unrelated symptoms. There are no current universal screening guidelines for MM. Among those who may benefit from MM screenings include African American/Black individuals, as it is twice as common in this population compared to Caucasian/White individuals. This study aims to develop a screening program specifically targeting underserved African American/Black individuals. This project will expand the existing Taussig Community Outreach screening program to include screening for multiple myeloma.

Eligibility criteria: Inclusion Criteria:

* Participant self-identifying as, or perceived as, Black and/or African-American
* 50 years of age or older

Exclusion Criteria:

* Participants who do not self-identify as Black and/or African American
* Under the age of 50 years

Primary outcomes:
measure: To conduct and evaluate a study that incorporates patient navigation programs to recruit and screen participants for Multiple Myeloma and its disease precursors, MGUS or smoldering MM
timeFrame: 12 months
measure: To conduct and evaluate a study that incorporates patient navigation programs to recruit and screen participants for Multiple Myeloma and its disease precursors, MGUS or smoldering MM
timeFrame: 12 months
measure: To study participant knowledge of Multiple Myeloma
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Jason Valent, MD
role: PRINCIPAL_INVESTIGATOR
References: