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

NCT05448196 | Completed

• 2 other identifiers: UPCC 39421850241
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Financial Toxicity

Outcome Measures

Primary Outcomes (1)

• COmprehensive Score for Financial Toxicity (COST)

  Primary outcome is assessing for change in participants' COmprehensive Score for Financial Toxicity (COST) from the baseline assessment to repeat assessment after 4 months of financial navigation. Scores range from 0-44, with lower scores representing greater financial hardship.

  4 months

Secondary Outcomes (2)

• Functional Assessment of Cancer Therapy (FACT-G)

  4 months

• Patient Satisfaction Questionnaire Short-Form [PSQ-18]

  4 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Coordinated Financial Navigation Program

Usual Care

NO INTERVENTION

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.

Interventions

Coordinated Financial Navigation Program 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Financial Stress

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Edward Stadtmauer, MD

  Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who consent to participation will complete an 11-item screener (the COST22; see "Primary Outcome" and "Screener"). Participants who are not at risk of financial toxicity (COST score ≥26) will be followed longitudinally (i.e., they will be given baseline and 4-month follow up assessments). Patients who score \<26 will be identified as being at risk of financial hardship and will be eligible for randomization to a coordinated financial navigation program or usual care.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 7, 2022
• Study Start: March 4, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Locations

US (1)