Assessing the Impact of a Financial Navigation Program for Patients With Multiple Myeloma: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 103
- Locations
- 2
- Primary Endpoint
- COmprehensive Score for Financial Toxicity (COST)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 #
- •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
Outcomes
Primary Outcomes
COmprehensive Score for Financial Toxicity (COST)
Time Frame: 4 months
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.
Secondary Outcomes
- Functional Assessment of Cancer Therapy (FACT-G)(4 months)
- Patient Satisfaction Questionnaire Short-Form [PSQ-18](4 months)