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Financial Navigation for Cancer (CAFE Trial)
N/A
Waitlist Available
Led By Matthew Banegas, PhD, MPH, MS
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Continuous enrollment at least 6 months prior to identification date
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights
CAFE Trial Summary
This trial is testing a financial navigation intervention to see if it impacts financial hardship, quality of life, cancer-related financial hardship, communication, and time to treatment.
Who is the study for?
This trial is for members of KPNW and KPWA who are over 18 years old, have been diagnosed with cancer (excluding non-melanoma skin cancer and benign or in situ tumors) within the last 120 days, speak English (or Spanish at KPNW), visited a CAFÉ clinic recently, and haven't been referred to hospice in the past year. They should not be on a do-not-contact list or have participated in related studies.Check my eligibility
What is being tested?
The study tests a 'financial navigation' service against 'enhanced usual care' to see if it helps reduce financial hardship and improves quality of life for new cancer patients. It also looks at how quickly patients start treatment after diagnosis.See study design
What are the potential side effects?
Since this trial focuses on financial guidance rather than medical treatments, there aren't typical medication side effects. However, participants may experience stress or emotional impacts from discussing financial issues.
CAFE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been enrolled in my current health plan for at least 6 months.
CAFE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Financial distress
Health-related quality of life (cancer specific)
Secondary outcome measures
Financial hardship due to cancer care costs
Other outcome measures
Delinquent account
Initiation of cancer treatment
Out of pocket (OOP) expenditures
+3 moreCAFE Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3: Extended financial navigation interventionExperimental Treatment1 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 II: Arm 2: Brief financial navigation interventionExperimental Treatment1 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 III: Arm 1: Enhanced usual careActive Control1 Intervention
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.
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Who is running the clinical trial?
Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,113,417 Total Patients Enrolled
Matthew Banegas, PhD, MPH, MSPrincipal InvestigatorUniversity of California, San Diego
Amanda Petrik, PhDC, MSPrincipal InvestigatorKaiser Permanente
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English.I have been enrolled in my current health plan for at least 6 months.My cancer is non-invasive or hasn't spread.My cancer diagnosis is for a type of skin cancer that is not melanoma.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Enhanced usual care
- Group 2: Arm 2: Brief financial navigation intervention
- Group 3: Arm 3: Extended financial navigation intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the enrollment size for this clinical experiment?
"Affirmative. Clinicaltrials.gov records show that this medical trial, which was uploaded on August 11th 2021, is enrolment-active and looking for 370 patients at one location."
Answered by AI
Are any vacancies available for this research trial?
"Per clinicaltrials.gov, this trial is still open for enrollment as of August 15th 2022. The registration process was first launched on November 8th 2021."
Answered by AI
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