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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Care | Study protocol

The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship

Authors: Nora B. Henrikson, Melissa L. Anderson, John Dickerson, John J. Ewing, Robin Garcia, Erin Keast, Deborah A. King, Cara Lewis, Blake Locher, Carmit McMullen, Consuelo M. Norris, Amanda F. Petrik, Arvind Ramaprasan, Jennifer S. Rivelli, Jennifer L. Schneider, Lisa Shulman, Leah Tuzzio, Matthew P. Banegas

Published in: Trials | Issue 1/2022

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Abstract

Background

There is an urgent need for evidence on how interventions can prevent or mitigate cancer-related financial hardship. Our objectives are to compare self-reported financial hardship, quality of life, and health services use between patients receiving a financial navigation intervention versus a comparison group at 12 months follow-up, and to assess patient-level factors associated with dose received of a financial navigation intervention.

Methods

The Cancer Financial Experience (CAFÉ) study is a multi-site randomized controlled trial (RCT) with individual-level randomization. Participants will be offered either brief (one financial navigation cycle, Arm 2) or extended (three financial navigation cycles, Arm 3) financial navigation. The intervention period for both Arms 2 and 3 is 6 months. The comparison group (Arm 1) will receive enhanced usual care. The setting for the CAFÉ study is the medical oncology and radiation oncology clinics at two integrated health systems in the Pacific Northwest. Inclusion criteria includes age 18 or older with a recent cancer diagnosis and visit to a study clinic as identified through administrative data. Outcomes will be assessed at 12-month follow-up. Primary outcomes are self-reported financial distress and health-related quality of life. Secondary outcomes are delayed or foregone care; receipt of medical financial assistance; and account delinquency. A mixed methods exploratory analysis will investigate factors associated with total intervention dose received.

Discussion

The CAFÉ study will provide much-needed early trial evidence on the impact of financial navigation in reducing cancer-related financial hardship. It is theory-informed, clinic-based, aligned with patient preferences, and has been developed following preliminary qualitative studies and stakeholder input. By design, it will provide prospective evidence on the potential benefits of financial navigation on patient-relevant cancer outcomes. The CAFÉ trial’s strengths include its broad inclusion criteria, its equity-focused sampling plan, its novel intervention developed in partnership with clinical and operations stakeholders, and mixed methods secondary analyses related to intervention dose offered and dose received. The resulting analytic dataset will allow for rich mixed methods analysis and provide critical information related to implementation of the intervention should it prove effective.

Trial registration

ClinicalTrials.gov NCT05018000. August 23, 2021.
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Metadata
Title
The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship
Authors
Nora B. Henrikson
Melissa L. Anderson
John Dickerson
John J. Ewing
Robin Garcia
Erin Keast
Deborah A. King
Cara Lewis
Blake Locher
Carmit McMullen
Consuelo M. Norris
Amanda F. Petrik
Arvind Ramaprasan
Jennifer S. Rivelli
Jennifer L. Schneider
Lisa Shulman
Leah Tuzzio
Matthew P. Banegas
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06344-3

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