Early Detection of Multiple Myeloma to Fight Cancer Disparities: A Screening and Patient Navigation Program

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05831358
Collaborator
(none)
200
1
1
24
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multiple Myeloma M-Protein Analysis
  • Other: Multiple Myeloma Knowledge Questionnaires
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Not a randomized trial; use of convenience sampling.Not a randomized trial; use of convenience sampling.
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Early Detection of Multiple Myeloma to Fight Cancer Disparities: A Screening and Patient Navigation Program
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multiple Myeloma Screening Experience

Participants will partake in a multiple myeloma screening program. The screening involves a blood sample and the completion of a questionnaire to gauge participants' multiple myeloma knowledge.

Other: Multiple Myeloma M-Protein Analysis
Participants will be screened with a blood test for monoclonal protein analysis

Other: Multiple Myeloma Knowledge Questionnaires
Participants will complete two questionnaires to share their attitudes toward their screening experience and completion of knowledge questions to gauge community reception and participant multiple myeloma knowledge.

Outcome Measures

Primary Outcome Measures

  1. 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 [12 months]

    The goal is to leverage the existing model of community outreach and patient navigation to study the MM screening program, including community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This will be measured by the overall community reception of this screening being offered.

  2. 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 [12 months]

    The goal is to leverage the existing model of community outreach and patient navigation to study the MM screening program, including community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This will be measured by participant questionnaires detailing their attitudes toward, and experience, of the screening.

  3. To study participant knowledge of Multiple Myeloma [12 months]

    Participants will gain knowledge about Multiple Myeloma from the time of the screening to the time of follow-up one week or more after the screening. This will be measured by examining the difference in participant post-screening questionnaire results.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland Ohio United States 44195

Sponsors and Collaborators

  • Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Jason Valent, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT05831358
Other Study ID Numbers:
  • CASE1A23
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023