Cancer Financial Experience

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Addressing Financial Hardship in Adolescent and Young Adult Cancer Survivors

NCT06881108

Hematopoietic Neoplasm Malignant Solid Neoplasm Lymphatic System Neoplasm

RECRUITING

Addressing Cancer-Related Financial Toxicity in Rural Oncology Care Settings

NCT04931251

Neoplasms Carcinoma

COMPLETED NA

Evaluating the Implementation and Impact of Standard-of-care Delivered Oncology Financial Navigation

NCT07281287

Oncology Financial Toxicity Counseling

RECRUITING NA

A Pilot Unrestricted Payment Program for Early-stage Cancer Patients: the PAYMENT Trial

NCT06771739

Malignant Solid Neoplasm

NOT_YET_RECRUITING NA

Financial Distress in Patients With Advanced Cancer

NCT01868100

Cancer Quality of Life

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: Enhanced usual care

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.

Group Type ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type BEHAVIORAL

The financial resource sheet lists and describes existing internal and community resources available to KP members

Arm 2: Brief financial navigation intervention

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.

Group Type EXPERIMENTAL

Financial navigation

Intervention Type BEHAVIORAL

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.

Arm 3: Extended financial navigation intervention

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).

Group Type EXPERIMENTAL

Financial navigation

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Financial navigation

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.

Intervention Type BEHAVIORAL

Enhanced usual care

The financial resource sheet lists and describes existing internal and community resources available to KP members

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No