Financial Navigation for Cancer

(CAFE Trial)

Overseen By Aaron Scrol

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Non-melanoma skin cancer, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

371 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

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

Eligibility Criteria

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.

Inclusion Criteria

KPNW and KPWA members with a new cancer diagnosis (within the past 120 days from identification date)

I have been enrolled in my current health plan for at least 6 months.

Recent visit to CAFÉ clinic/department

Exclusion Criteria

My cancer is non-invasive or hasn't spread.

My cancer diagnosis is for a type of skin cancer that is not melanoma.

Hospice referral in past year

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive financial navigation intervention to address financial hardship during cancer treatment

6 months

At least 1 phone call per cycle with a CAFÉ Financial Navigator

Follow-up

Participants are monitored for financial hardship and health-related quality of life

12 months

Treatment Details

Interventions

• Enhanced usual care
• Financial navigation

Trial Overview 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.

Participant Groups

Group I: Arm 3: Extended financial navigation intervention Experimental Treatment 1 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 intervention Experimental Treatment 1 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 care Active Control 1 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.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+