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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05448196
Recruitment Status : Recruiting
First Posted : July 7, 2022
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Other: Coordinated Financial Navigation Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assessing the Impact of a Financial Navigation Program for Patients With Multiple Myeloma: a Randomized Controlled Trial
Actual Study Start Date : March 4, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: 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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Functional Assessment of Cancer Therapy (FACT-G) [ Time Frame: 4 months ]
    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.

  2. Patient Satisfaction Questionnaire Short-Form [PSQ-18] [ Time Frame: 4 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05448196


Contacts
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Contact: Edward Stadtmauer, MD (215) 349-8334 stadtmae@uphs.upenn.edu
Contact: Mia Djulbegovic, MD, MHS (267) 760-1962 mailto:mia.djulbegovic@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Penn Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katie Fanslau, DNP, RN    215-360-0577      
Contact: Mia Djulbegovic, MD, MHS    (267) 760-1962      
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Edward Stadtmauer, MD Penn Medicine
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT05448196    
Other Study ID Numbers: UPCC 39421
850241 ( Other Identifier: Penn Medicine )
First Posted: July 7, 2022    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Financial Toxicity
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases