Financial Navigation Study Among Young Adult Blood Cancer Survivors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05620979
• Other study ID #: STUDY00001828
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: June 30, 2024
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Financial Stress
• Hematologic Neoplasms
• Survivorship

Intervention

Behavioral:
• Providing financial navigation via active navigation, ad hoc navigation or no study-based navigation.
Providing financial navigation to blood cancer survivors.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Bon Secours Mercy Health System	Greenville	South Carolina
United States	MD Anderson	Houston	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of Southern California (USC Norris Comprehensive Cancer Center & LA County Hospital)	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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