CancerCAFENCT05018000
Cancer Financial Experience
A study testing Financial navigation in people with Cancer, run by Kaiser Permanente at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Financial navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: CAFÉ: Clinic Based Intervention to Address Financial Hardship for People With Cancer
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Financial navigation, Enhanced usual care
- Keywords
- financial hardship, cancer, health outcomes
- Medical subject headings
- Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial navigationBehavioural
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.
Enhanced usual careBehavioural
The financial resource sheet lists and describes existing internal and community resources available to KP members
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Enhanced usual care | Active comparator | 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. Receives: Behavioral: Enhanced usual care |
| Arm 2: Brief financial navigation intervention | Experimental | 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. Receives: Behavioral: Financial navigation |
| Arm 3: Extended financial navigation intervention | Experimental | 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). Receives: Behavioral: Financial navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline and 12 months
Secondary outcomes (1)
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)
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start11 Aug 2021
- Primary completion1 Mar 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nora B Henrikson, PhD, MPH, Principal investigator, Kaiser PermanenteMatthew Banegas, PhD, MPH, MS, Principal investigator, University of California, San DiegoAmanda Petrik, PhDC, MS, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018000
- Sponsor's protocol ID
- 1R01CA237322
- Acronym
- CAFE
- Status last verified
- Jan 2026
- First submitted
- 18 Aug 2021
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henrikson NB, Anderson ML, Dickerson J, Petrik AF, Figueroa Gray M, Ewing JJ, Garcia R, Keast E, King DA, Locher B, Scrol A, Ramaprasan A, Rivelli JS, Schneider JL, Banegas MP. Financial Navigation for People Newly Diagnosed With Cancer: Primary Outcomes From the Cancer Financial Experience Randomized Trial. JCO Oncol Pract. 2025 Dec;21(12):1817-1829. doi: 10.1200/OP-25-00874. Epub 2025 Oct 10.
PubMed 41070850Henrikson 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.
PubMed 35562781
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAFÉ: Clinic Based Intervention to Address Financial Hardship for People With Cancer
- ClinicalTrials.gov ID
- NCT05018000
- Acronym / sponsor ID
- CAFE / 1R01CA237322
- Conditions
- Cancer
- Keywords
- financial hardship, cancer, health outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Enhanced usual care | Active comparator | Behavioral: Enhanced usual careParticipants 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. |
| Arm 2: Brief financial navigation intervention | Experimental | Behavioral: Financial navigationParticipants 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. |
| Arm 3: Extended financial navigation intervention | Experimental | Behavioral: Financial navigationParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial navigationThe 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. | Behavioural | Arm 2: Brief financial navigation intervention, Arm 3: Extended financial navigation intervention |
| Enhanced usual careThe financial resource sheet lists and describes existing internal and community resources available to KP members | Behavioural | Arm 1: Enhanced usual care |
Primary outcome
Financial distress
Time frame: baseline and 12 months
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.
Health-related quality of life (cancer specific)
Time frame: baseline and 12 months
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.
1 secondary outcome
Financial hardship due to cancer care costs
Time frame: baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 41070850Henrikson NB, Anderson ML, Dickerson J, Petrik AF, Figueroa Gray M, Ewing JJ, Garcia R, Keast E, King DA, Locher B, Scrol A, Ramaprasan A, Rivelli JS, Schneider JL, Banegas MP. Financial Navigation for People Newly Diagnosed With Cancer: Primary Outcomes From the Cancer Financial Experience Randomized Trial. JCO Oncol Pract. 2025 Dec;21(12):1817-1829. doi: 10.1200/OP-25-00874. Epub 2025 Oct 10.
- Derived from this study: PubMed 35562781Henrikson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora B Henrikson, PhD, MPH principal investigator
Kaiser Permanente
Matthew Banegas, PhD, MPH, MS principal investigator
University of California, San Diego
Amanda Petrik, PhDC, MS principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial navigation in people with Cancer, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Financial distress (time frame: baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018000, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.