Cancer Financial Experience

Study Overview
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Brief Summary
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This study is a randomized clinical trial designed to test a novel financial navigation intervention. The study assesses the impact of the financial navigation intervention on financial hardship and health-related quality of life, cancer-related material and psychological financial hardship, patient-centered communication, and time to initiation of treatment.

Detailed Description
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Rationale: Up to half of people with cancer experience financial hardship. Cancer-related financial hardship is associated with several adverse intermediate and health outcomes, including poor quality of life, treatment non-adherence, and lower survival. Observational evidence suggests that communication about financial concerns and out-of-pocket (OOP) costs early in the treatment trajectory and in partnership with the care team could help to prevent or lessen financial hardship. This type of communication could be delivered through patient navigation programs and is consistent with both patient and care team preferences. However, to date there is no evidence from randomized trials showing the impact of financial navigation during the active treatment on financial hardship. Further, no intervention-based studies have provided evidence on the most effective ways to mitigate cancer-related financial hardship. Background: As costs of cancer care in U.S. have risen over time, so has the burden of out-of-pocket (OOP) costs and indirect costs such as travel, employment changes, and caregiver costs. These cumulative costs pose increased financial risk for people diagnosed with cancer. Despite a patient's health insurance status, financial hardship from cancer care is prevalent: 47%-49% of cancer survivors report financial hardship and 12%-62% of cancer survivors report debt due to treatment costs. Financial hardship is associated with decreased treatment initiation and adherence, poor symptoms and quality of life, and increased mortality risk, so preventing or mitigating its effects is a clinical imperative. Integration of cost of cancer care information into conversations between patients and clinicians can optimize medical decision-making and reduce the risk of financial hardship, and is consistent with high-quality cancer care and patient preferences. Patient understanding of OOP costs can assist with planning and budgeting, and can facilitate early connection with financial support services that may help to mitigate the financial burden of cancer care. Yet, less than one in five patients report having cost discussions. Consequently, many patients are uninformed about the costs of their cancer care and face unexpected OOP costs, with important consequences for material (e.g., debt), psychological (e.g., cost-related distress), and behavioral (e.g. treatment adherence) financial hardship. There is an urgent need for evidence-based interventions on how to prevent or mitigate financial hardship for people with cancer. While the extent of financial hardship as a toxicity of cancer care is increasingly well-documented, there is limited evidence to date as to what types of interventions can mitigate or prevent financial hardship due to cancer care. Policy, societal, and organizational-level interventions, such as those focused on bending the curve of rising health care cost or improving price transparency to ordering providers are all needed, but these may take a long time or show limited effect. In the meantime, patients continue to need assistance navigating, managing and anticipating OOP costs, and patient- and team level-interventions such as the CAFÉ study may hold promise for this purpose.

Official Title
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CAFÉ: Clinic Based Intervention to Address Financial Hardship for People With Cancer

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Financial navigation
* Behavioral: Enhanced usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: KPNW and KPWA members with a new cancer diagnosis (within the past 120 days from identification date) 18+ years of age (based on age at time of identification date) Recent visit to CAFÉ clinic/department Current, living member as of identification date Continuous enrollment at least 6 months prior to identification date English speaker for KPWA; English or Spanish speaker for KPNW Exclusion Criteria: On do-not contact list at KP Cancer diagnosis is for non-melanoma skin cancer Cancer diagnosis is for a benign or in situ tumor Hospice referral in past year Self or household member has already enrolled or completed participation in CAFÉ pilot study or main trial. Unable to complete survey

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Enhanced usual care<br>Participants in this arm will receive their usual care plus a Financial Resource Sheet. The financial resource sheet lists and describes existing organization and community resources available to KP members. | Behavioral: Enhanced usual care<br>* The financial resource sheet lists and describes existing internal and community resources available to KP members<br>|
| Experimental: Arm 2: Brief financial navigation intervention<br>Participants in this arm will receive their usual care, and the Financial Resource Sheet described in Arm 1, plus one (1) cycle of financial navigation (total cycles: 1; total length: 6 months). In each intervention cycle participants will get at least one (1) phone call with a CAFÉ Financial Navigator, the navigator will talk with participants to identify financial questions or concerns. The navigator will create a personalized plan for each participant. Participants can request extra support from the navigator for up to 6 months. | Behavioral: Financial navigation<br>* The CAFÉ intervention is a financial navigation intervention. During the Intervention, a CAFÉ financial navigator will provide information support and resources to people with cancer after diagnosis. CAFÉ intervention components include: (1) proactive assessment of patient financial questions and concerns (e.g., acute financial need or inability to pay for household expenses; deciding between care options depending on cost; uncertainty around planning for out of pocket costs and/or when patients will need to pay), (2) proactive, personalized support and referrals.<br>|
| Experimental: Arm 3: Extended financial navigation intervention<br>Participants in this arm will receive their usual care, a Financial Resource Sheet and the brief intervention described in Arm 2 (i.e., one (1) cycle of financial navigation). Plus, they will receive two (2) additional cycles of financial navigation (total cycles: 3; total length: 6 months). | Behavioral: Financial navigation<br>* The CAFÉ intervention is a financial navigation intervention. During the Intervention, a CAFÉ financial navigator will provide information support and resources to people with cancer after diagnosis. CAFÉ intervention components include: (1) proactive assessment of patient financial questions and concerns (e.g., acute financial need or inability to pay for household expenses; deciding between care options depending on cost; uncertainty around planning for out of pocket costs and/or when patients will need to pay), (2) proactive, personalized support and referrals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Financial distress | InCharge Financial Distress/Financial Well-Being Scale. This is a validated, 8-item scale that assesses current ability to meet financial obligations, stress or worry about finances, and satisfaction with present financial situation. It is scored to a 10-point scale, where 1 is Overwhelming financial distress/lowest financial well-being, and 10 is No financial distress/highest financial well-being. It has been validated in multiple populations and national norms are provided. | baseline and 12 months | 
| Health-related quality of life (cancer specific) | The FACT-G7 is a 7-item version of the Functional Assessment of Cancer Therapy-General (FACT-G), a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. Higher scores represent higher quality of life. | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Financial hardship due to cancer care costs | Items from the Medical Expenditure Panel Survey (Yabroff 2016): Material financial hardship items: Have you or has anyone in your family had to borrow money or go into debt because of your cancer, its treatment or the lasting effects of that treatment? (Yes\No) Did you or your family ever file for bankruptcy because of your cancer, its treatment, or the lasting effects of that treatment? (Yes\No) Have you or your family had to make any other kinds of financial sacrifices because of your cancer, its treatment, or the lasting effects of that treatment? (Yes\No) Please think about medical care visits for cancer, its treatment, or the lasting effects of that treatment. Have you ever been unable to cover your share of those visits? (Yes\No) Psychological financial hardship item: Have you ever worried about having to pay large medical bills related to your cancer? (Yes\No) | baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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financial hardship, cancer, health outcomes