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Financial Navigation Study Among Young Adult Blood Cancer Survivors

Primary Purpose

Survivorship, Cancer, Financial Stress

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Providing financial navigation via active navigation, ad hoc navigation or no study-based navigation.
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Survivorship

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Previous diagnosis and treatment of blood cancer (leukemia, lymphoma, myeloma, myelodysplastic syndrome, or myeloproliferative neoplasm) Current age between 18-39 years old Blood cancer diagnosis during childhood (0-17 years of age) or young adulthood (18-36 years of age) At least three years post blood cancer diagnosis Off treatment for blood cancer or on a long-term regimen with an oral anti-cancer medication with stable disease Off treatment for a second cancer (non-blood cancer) or on a stable long-term regimen, such as hormone therapy or hormone replacement therapy Primary residence in United States Able to understand and read the English language Exclusion Criteria: On parent or guardian's insurance

Sites / Locations

  • Children's Hospital Los Angeles
  • University of Southern California (USC Norris Comprehensive Cancer Center & LA County Hospital)
  • Tufts Medical Center
  • Bon Secours Mercy Health System
  • MD Anderson

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Active Navigation

Ad Hoc Navigation

No study-based Navigation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 31, 2022
Last Updated
August 8, 2023
Sponsor
Tufts Medical Center
Collaborators
The Leukemia and Lymphoma Society
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1. Study Identification

Unique Protocol Identification Number
NCT05620979
Brief Title
Financial Navigation Study Among Young Adult Blood Cancer Survivors
Official Title
Evaluating the Role of Financial Navigation in Alleviating Financial Distress Among Young Adult Survivors of Blood Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
The Leukemia and Lymphoma Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Survivorship, Cancer, Financial Stress

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a multi-site, three-arm, financial navigation intervention
Masking
None (Open Label)
Masking Description
no blinding
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Navigation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ad Hoc Navigation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No study-based Navigation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Providing financial navigation via active navigation, ad hoc navigation or no study-based navigation.
Intervention Description
Providing financial navigation to blood cancer survivors.
Primary Outcome Measure Information:
Title
Personal Financial Wellness Scale (PFW)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Health-Related Quality of Life (HrQoL) Measures
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previous diagnosis and treatment of blood cancer (leukemia, lymphoma, myeloma, myelodysplastic syndrome, or myeloproliferative neoplasm) Current age between 18-39 years old Blood cancer diagnosis during childhood (0-17 years of age) or young adulthood (18-36 years of age) At least three years post blood cancer diagnosis Off treatment for blood cancer or on a long-term regimen with an oral anti-cancer medication with stable disease Off treatment for a second cancer (non-blood cancer) or on a stable long-term regimen, such as hormone therapy or hormone replacement therapy Primary residence in United States Able to understand and read the English language Exclusion Criteria: On parent or guardian's insurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K Parsons, MD, MRP
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of Southern California (USC Norris Comprehensive Cancer Center & LA County Hospital)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Bon Secours Mercy Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Financial Navigation Study Among Young Adult Blood Cancer Survivors

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