Financial Navigation Study Among Young Adult Blood Cancer Survivors

Sponsor
Tufts Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05620979
Collaborator
The Leukemia and Lymphoma Society (Other)
260
5
3
22.5
52
2.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Providing financial navigation via active navigation, ad hoc navigation or no study-based navigation.
N/A

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 Scaleā„¢ (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 Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a multi-site, three-arm, financial navigation interventionThis is a multi-site, three-arm, financial navigation intervention
Masking:
None (Open Label)
Masking Description:
no blinding
Primary Purpose:
Health Services Research
Official Title:
Evaluating the Role of Financial Navigation in Alleviating Financial Distress Among Young Adult Survivors of Blood Cancer
Actual Study Start Date :
Feb 14, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Personal Financial Wellness Scale (PFW) [6 months]

    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

  1. Health-Related Quality of Life (HrQoL) Measures [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital Los Angeles Los Angeles California United States 90027
2 University of Southern California (USC Norris Comprehensive Cancer Center & LA County Hospital) Los Angeles California United States 90033
3 Tufts Medical Center Boston Massachusetts United States 02111
4 Bon Secours Mercy Health System Greenville South Carolina United States 29607
5 MD Anderson Houston Texas United States 77030

Sponsors and Collaborators

  • Tufts Medical Center
  • The Leukemia and Lymphoma Society

Investigators

  • Principal Investigator: Susan K Parsons, MD, MRP, Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT05620979
Other Study ID Numbers:
  • STUDY00001828
First Posted:
Nov 17, 2022
Last Update Posted:
Nov 17, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2022