Financial Navigation Study Among Young Adult Blood Cancer Survivors

Evaluating the Role of Financial Navigation in Alleviating Financial Distress Among Young Adult Survivors of Blood Cancer

Young adult cancer survivors (18-39y) are at increased risk of financial distress. This study seeks to better understand the financial challenges experienced by these individuals via quantitative serial assessments, study-based financial navigator encounters and an end of study qualitative interview.

Study Overview

• Status: Completed
• Conditions: Cancer; Financial Stress; Survivorship
• Intervention / Treatment: Behavioral: Providing financial navigation via active navigation, ad hoc navigation or no study-based navigation.

Detailed Description

This fully remote, multi-site study will evaluate the role of financial navigators in relieving financial distress in young adults (18-39y) who have completed treatment for blood cancer at least three years ago. Serial Assessments at study entry, 3-months, and 6-months measure financial distress measured using the study's primary outcome measure the Personal Financial Wellness Scale™ (PFW) (see below), hypothesized effect modifiers (emotional distress, self-efficacy, cognitive functioning), as well as care seeking, household finances and insurance characteristics. Randomization will occur following completion of baseline measures (see below for description of study arms). In addition to a formal evaluation of the intervention at 3- and 6-months, an optional interview will occur following the 6-month assessment/navigation intervention period to gain further insight from participants about the acceptability of the intervention. For ethical considerations related to the topic of study, all participants will be provided with the Leukemia & Lymphoma Society's information specialist hotline.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • Los Angeles, California, United States, 90033
      • University of Southern California (USC Norris Comprehensive Cancer Center & LA County Hospital)
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Bon Secours Mercy Health System
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Previous diagnosis and treatment of blood cancer (leukemia, lymphoma, myeloma, myelodysplastic syndrome, or myeloproliferative neoplasm)
2. Current age between 18-39 years old
3. Blood cancer diagnosis during childhood (0-17 years of age) or young adulthood (18-36 years of age)
4. At least three years post blood cancer diagnosis
5. Off treatment for blood cancer or on a long-term regimen with an oral anti-cancer medication with stable disease
6. Off treatment for a second cancer (non-blood cancer) or on a stable long-term regimen, such as hormone therapy or hormone replacement therapy
7. Primary residence in United States
8. Able to understand and read the English language

Exclusion Criteria:

• On parent or guardian's insurance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Navigation; Active navigation with the study-based financial navigator scheduling four check-in meetings throughout the study with the participant. All participants will complete an assessment at baseline, 3 months and 6 months and be invited to participate in an optional interview after the 6-month assessment.	Behavioral: Providing financial navigation via active navigation, ad hoc navigation or no study-based navigation.; Providing financial navigation to blood cancer survivors.
Active Comparator: Ad Hoc Navigation; Ad hoc navigation in which participant is provided study-based financial navigator to contact as needed. All participants will complete an assessment at baseline, 3 months and 6 months and be invited to participate in an optional interview after the 6-month assessment.	Behavioral: Providing financial navigation via active navigation, ad hoc navigation or no study-based navigation.; Providing financial navigation to blood cancer survivors.
Active Comparator: No study-based Navigation; No access to a study-based financial navigator, but access to a national hotline through the Leukemia & Lymphoma Society. All participants will complete an assessment at baseline, 3 months and 6 months and be invited to participate in an optional interview after the 6-month assessment.	Behavioral: Providing financial navigation via active navigation, ad hoc navigation or no study-based navigation.; Providing financial navigation to blood cancer survivors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Financial Wellness Scale (PFW)	To evaluate the change in financial distress associated with randomization group assignment from baseline to 6-month follow up as measured by the 8-item Personal Financial Wellness Scale (PFW). The PFW scores range from 1-10 where lower scores indicate greater financial distress.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life (HrQoL) Measures	As part of Aim 1, we will explore whether changes in financial distress (baseline to 6-months) are moderated by emotional distress, self-efficacy, and cognitive functioning, as measured by Patient-Reported Measurement Information System (PROMIS) 4-item short forms for emotions distress (depression and anxiety) and self-efficacy, as well as the 4-item cognitive functioning scale from the Quality of Life in Neurological Disorders (Neuro-Qol) battery. For each of these short forms, high scores connote better functioning.	6 months

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: The Leukemia and Lymphoma Society
• Investigators: Principal Investigator: Susan K Parsons, MD, MRP, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): November 6, 2023
• Study Completion (Actual): November 23, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Behavioral Symptoms; Hematologic Diseases; Stress, Psychological; Financial Stress; Hematologic Neoplasms
• Other Study ID Numbers: STUDY00001828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No