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

Multiple Myeloma Clinical Trial

Official title:

Assessing the Impact of a Financial Navigation Program for Patients With Multiple Myeloma: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448196
• Other study ID #: UPCC 39421
• Secondary ID: 850241
• Status: Completed
• Phase: N/A
• Start date: March 4, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: June 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional Assessment of Cancer Therapy (FACT-G)	Secondary outcome is assessing for change in participants' Health Related Quality of Life (HRQOL) as measured in part by the Functional Assessment of Cancer Therapy (FACT-G) from the baseline assessment to repeat assessment after 4 months of financial navigation. The FACT-G includes 4 subscales (physical well-being, social/family well-being, emotional well-being, and functional well-being). The score ranges from 0-108 with a higher score indicating better quality of life.	4 months
Secondary	Patient Satisfaction Questionnaire Short-Form [PSQ-18]	Secondary outcome is assessing for change in participants' HRQOL as measured in part by the Patient Satisfaction Questionnaire Short-Form [PSQ-18] from the baseline assessment to repeat assessment after 4 months of financial navigation. The PSQ-18 includes 7 subscales (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and convenience). The score ranges from 18-90 points with higher scores indicating increased patient satisfaction.	4 months