Clinical trial NCT05018000: Cancer Financial Experience
Official title: CAFÉ: Clinic Based Intervention to Address Financial Hardship for People With Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: financial hardship
cancer
health outcomes
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. KPNW and KPWA members with a new cancer diagnosis (within the past 120 days from identification date)
2. 18+ years of age (based on age at time of identification date)
3. Recent visit to CAFÉ clinic/department
4. Current, living member as of identification date
5. Continuous enrollment at least 6 months prior to identification date
6. English speaker for KPWA; English or Spanish speaker for KPNW

Exclusion Criteria:

1. On do-not contact list at KP
2. Cancer diagnosis is for non-melanoma skin cancer
3. Cancer diagnosis is for a benign or in situ tumor
4. Hospice referral in past year
5. Self or household member has already enrolled or completed participation in CAFÉ pilot study or main trial.
6. Unable to complete survey

Primary outcomes:
measure: Financial distress
timeFrame: baseline and 12 months
measure: Health-related quality of life (cancer specific)
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Financial hardship due to cancer care costs
timeFrame: baseline and 12 months
Other outcomes:
measure: Initiation of cancer treatment
timeFrame: between baseline and 12 months
measure: Time to initiation of cancer treatment
timeFrame: between baseline and 12 months
measure: Use of medical financial assistance (MFA)
timeFrame: between baseline and 12 months
measure: Delinquent account
timeFrame: between baseline and 12 months
measure: Out of pocket (OOP) expenditures
timeFrame: between baseline and 12 months
measure: Patient Assessment of cancer Communication Experiences (PACE)
timeFrame: between baseline and 12 months
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Nora B Henrikson, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Matthew Banegas, PhD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Amanda Petrik, PhDC, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henrikson NB, Anderson ML, Dickerson J, Ewing JJ, Garcia R, Keast E, King DA, Lewis C, Locher B, McMullen C, Norris CM, Petrik AF, Ramaprasan A, Rivelli JS, Schneider JL, Shulman L, Tuzzio L, Banegas MP. The Cancer Financial Experience (CAFE) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship. Trials. 2022 May 13;23(1):402. doi: 10.1186/s13063-022-06344-3.