Cancer Financial Experience

NCT05018000 | Completed

• 1 other identifier: 1R01CA237322
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

financial hardship; cancer; health outcomes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline and 12 months

Secondary Outcomes (1)

• Financial hardship due to cancer care costs

  baseline and 12 months

Other Outcomes (6)

• Initiation of cancer treatment

  between baseline and 12 months

• Time to initiation of cancer treatment

  between baseline and 12 months

• Use of medical financial assistance (MFA)

  between baseline and 12 months

Study Arms (3)

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.

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.

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).

Behavioral: Financial navigation

Interventions

Enhanced usual care BEHAVIORAL

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

Arm 1: Enhanced usual care

Financial navigation 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 2: Brief financial navigation intervention; Arm 3: Extended financial navigation intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (2)

• 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.

  PMID: 41070850 DERIVED

• 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.

  PMID: 35562781 DERIVED

MeSH Terms

Conditions

Neoplasms; Financial Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Nora B Henrikson, PhD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Matthew Banegas, PhD, MPH, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Amanda Petrik, PhDC, MS

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: August 11, 2021
• Primary Completion: March 1, 2025
• Study Completion: August 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)