Clinical trial NCT05448196: Assessing the Impact of a Financial Navigation Program for Patients With Multiple Myeloma
Official title: Assessing the Impact of a Financial Navigation Program for Patients With Multiple Myeloma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: Financial Toxicity
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: COmprehensive Score for Financial Toxicity (COST)
timeFrame: 4 months
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy (FACT-G)
timeFrame: 4 months
measure: Patient Satisfaction Questionnaire Short-Form [PSQ-18]
timeFrame: 4 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
affiliation: Penn Medicine
name: Edward Stadtmauer, MD
role: PRINCIPAL_INVESTIGATOR
References: