Assessing the Impact of a Financial Navigation Program for Patients With Multiple Myeloma

NCT ID: NCT05448196

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-04
• Study Completion Date: 2023-06-22

Brief Summary

The study is a randomized controlled trial to develop and evaluate a coordinated financial navigation program at the Abramson Cancer Center (ACC) for patients with multiple myeloma and identify barriers to its broader implementation.

Detailed Description

Many financial support services are available to patients at the ACC, but are offered by different umbrella departments and rely on self- or clinician-referrals. Financial Advocacy provides assistance with insurance benefits, copayment assistance and hospital-based financial support. Social work assists with costs not directly related to treatment and also connects patients with community resources. Programs that increase coordination between these departments and proactively screen patients for financial hardship may enhance the reach of available services. However, such programs are resource intensive. As such, obtaining a better understanding of their benefits and any barriers to their expansion is a necessary first step to their broader implementation.

The long-term goal is to implement evidence-based practices that reduce ACC patients' financial burden. The overall objective of this proposal is to develop and evaluate a coordinated financial navigation program at the ACC for patients with multiple myeloma and identify barriers to its broader implementation. The rationale is that understanding the program's effectiveness and any barriers to its scalability will guide the way in which it could be incorporated into existing ACC workflows to maximize benefit for patients.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Patients randomized to the intervention arm will be enrolled in a four-month coordinated financial navigation program. This program will take a more proactive, coordinated, and systematic approach and includes concrete action plans, and frequent and standardized follow-ups. All patients randomized to the intervention arm will meet with the nurse navigator (NN) for an intake. The NN will introduce navigation services and navigator's NN role and describe the financial navigation program (e.g., goals and expectations of the financial advocacy and social work programs). Next, the navigator will elicit from the patient their potential and current barriers to completing the diagnostic test or treatment. The navigator will then perform proactive outreach to these resources and coordinate an action plan with the patient.

Group Type: EXPERIMENTAL

Coordinated Financial Navigation Program

Intervention Type: OTHER

Patients randomized to the intervention arm will be enrolled in a four-month coordinated financial navigation program. This program will take a more proactive, coordinated, and systematic approach and includes concrete action plans, and frequent and standardized follow-ups. All patients randomized to the intervention arm will meet with the nurse navigator (NN) for an intake. The NN will introduce navigation services and navigator's NN role and describe the financial navigation program (e.g., goals and expectations of the financial advocacy and social work programs). Next, the navigator will elicit from the patient their potential and current barriers to completing the diagnostic test or treatment. The navigator will then perform proactive outreach to these resources and coordinate an action plan with the patient.

Usual Care

Patients are connected to financial advocacy and social work on an ad hoc basis, rather than systematically. We hypothesize that many patients who would qualify and benefit from these services are not using them or are being referred late in their treatment course, which is contributing to their financial hardship and adversely affecting their healthcare.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coordinated Financial Navigation Program

Patients randomized to the intervention arm will be enrolled in a four-month coordinated financial navigation program. This program will take a more proactive, coordinated, and systematic approach and includes concrete action plans, and frequent and standardized follow-ups. All patients randomized to the intervention arm will meet with the nurse navigator (NN) for an intake. The NN will introduce navigation services and navigator's NN role and describe the financial navigation program (e.g., goals and expectations of the financial advocacy and social work programs). Next, the navigator will elicit from the patient their potential and current barriers to completing the diagnostic test or treatment. The navigator will then perform proactive outreach to these resources and coordinate an action plan with the patient.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1. Patients actively receiving systemic therapy at the ACC, defined as receiving any anti-myeloma treatment and at least monthly follow-up at PCAM4 or one of our satellite locations (CCH, Princeton, Lancaster, Cherry Hill, Valley Forge, Radnor)

• These patients will be approached/recruited in-person on the same date as their return visit (follow-up appointment for established patients)
• These patients may have already been seen by FA/SW (we will record this information and control for this in the final statistical models)
• The rationale for using the "follow up at least monthly" criterion is because it will allow our research coordinators to easily and readily review charts of patients scheduled for follow up with myeloma specialists. This strategy will only exclude patients who receive oral maintenance anti-myeloma therapy who follow up less than once monthly (e.g. lenalidomide maintenance only).

2. New patients expected to start therapy, who are expected to meet criterion #1.

• These patients will be approached/recruited at their first return visit.
• If these patients are not expected to return within 2 weeks of the initial visit, a telephone consent will be considered/offered

Exclusion Criteria

• o Have completed induction treatment and have stopped all systemic treatment in preparation for an autologous stem cell transplant [SCT] (rationale: patients are pre-screened for being able to finance their transplant before proceeding)

• Are referred only for autologous SCT (they would not qualify by criterion #1, anyway)
• Actively receive systemic therapy but do not follow up more than once monthly

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Stadtmauer, MD

Role: PRINCIPAL_INVESTIGATOR

Penn Medicine

Locations

Penn Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

850241

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 39421

Identifier Type: -

Identifier Source: org_study_id