Financial Navigation Intervention in Improving Financial and Clinical Outcomes in Patients With Newly Diagnosed Gastric or Gastroesophageal Junction Adenocarcinoma

Not Applicable

Completed

• Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
• Interventions: Other: Media Intervention; Other: Best Practice; Other: Informational Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

• Registration Number: NCT03986502
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

This trial studies how well a financial navigation intervention works in improving financial and clinical outcomes in patients with newly diagnosed gastric or gastroesophageal junction adenocarcinoma. Financial toxicity is a term used to summarize cancer-related financial hardship, including both the material (e.g. debt) and psychological (e.g. anxiety about costs) aspects. Cancer patients who experience financial toxicity are at greater risk for treatment non-adherence, poorer quality of life, and worse survival. Caregivers also share in this experience of financial toxicity and often spend money on food, medications, and other patient needs in addition to taking time off from work to provide logistical, emotional, and medical support. Financial navigation interventions that address the shared household financial concerns of patients and their caregivers may not only improve the patient outcomes but also improve caregiver burden, quality of life, and ability to perform caregiver roles more effectively.

Detailed Description

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (FINANCIAL NAVIGATION PROGRAM): Patients and caregivers watch a web-based financial literacy video and receive information about financial counseling, direct medical cost and healthcare coverage assistance, and indirect and non-medical cost assistance.

ARM II (USUAL CARE): Patients and caregivers participate in usual clinic procedures and utilize any available clinic or community-based financial resources.

Study Timeline

• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-14
• Study Start: 2021-01-22
• Status Verified: 2022-10
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• PATIENT: English-speaking
• PATIENT: Diagnosis of gastric and/or gastroesophageal junction (GEJ) adenocarcinoma within 6 months of consent (any stage)
• PATIENT: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• PATIENT: Receiving (or will receive) chemotherapy, radiation, or other systemic therapy (including targeted drug or immune checkpoint inhibitor)
• CAREGIVER: English-speaking

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Exclusion Criteria

• PATIENT: Enrolled in hospice care at the time of enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (financial navigation program)	Media Intervention	Patients and caregivers watch a web-based financial literacy video and receive information about financial counseling, direct medical cost and healthcare coverage assistance, and indirect and non-medical cost assistance.
Arm I (financial navigation program)	Informational Intervention	Patients and caregivers watch a web-based financial literacy video and receive information about financial counseling, direct medical cost and healthcare coverage assistance, and indirect and non-medical cost assistance.
Arm I (financial navigation program)	Questionnaire Administration	Patients and caregivers watch a web-based financial literacy video and receive information about financial counseling, direct medical cost and healthcare coverage assistance, and indirect and non-medical cost assistance.
Arm I (financial navigation program)	Quality-of-Life Assessment	Patients and caregivers watch a web-based financial literacy video and receive information about financial counseling, direct medical cost and healthcare coverage assistance, and indirect and non-medical cost assistance.
Arm II (usual care)	Best Practice	Patients and caregivers participate in usual clinic procedures and utilize any available clinic or community-based financial resources. Patients and caregivers will also be provided the financial navigation videos and worksheets from the intervention.
Arm II (usual care)	Questionnaire Administration	Patients and caregivers participate in usual clinic procedures and utilize any available clinic or community-based financial resources. Patients and caregivers will also be provided the financial navigation videos and worksheets from the intervention.
Arm II (usual care)	Quality-of-Life Assessment	Patients and caregivers participate in usual clinic procedures and utilize any available clinic or community-based financial resources. Patients and caregivers will also be provided the financial navigation videos and worksheets from the intervention.

Primary Outcome Measures

Name	Time	Method
Caregiver burden	Baseline up to 6 months	Assessed via the social well-being subscale of the City of Hope Quality of Life questionnaire.
Qualitative assessment of usual care and intervention	Up to 6 months	Usual care arm dyads will be surveyed about availability (or lack), access to, and use of financial assistance via the clinic and community. Intervention arm dyads will be surveyed about availability and use of financial assistance from the clinic, community, and navigation partners. Will evaluate Consumer Education and Training Services (CENTS)'s and Patient Advocate Foundation (PAF)'s documentation and characterize the interventions made on behalf of dyads in subgroups categorized by age, gender, income, and financial fragility. We will review all unresolved issues reported by CENTS and PAF and describe the frequency and type by subgroup. We will describe dyads' use of clinic and community-based financial assistance resources in both study arms across subgroups, noting barriers to access if present.
Number of Participants that have experienced Household financial hardship	Up to 6 months	Financial Hardship is defined as self-report of accrual of debt, taking out loans for cancer treatment or decline in household income \<=20%
Caregiver quality of life	Baseline up to 6 months	City of Hope Quality of Life Family version, a well-validated tool with 37 items and 4 subscales (scored 0-10 per item). A change in score of 2 points per item is considered clinically meaningful.
Patient quality of life: FACT-G	Baseline up to 6 months	Composite score from the FACT-G. A 6-point score change is considered clinically meaningful in US cancer populations.
Subjective financial distress	Baseline up to 6 months	Assessed using Comprehensive Score for Financial Toxicity-Patient Reported Outcome Measure (COST-FACIT). Mean scores (and standard deviations) at 3 and 6 months will be compared between intervention and control patients and caregivers using two sample t tests. Additionally, will explore the extent to which subjective financial distress correlates with financial hardship by comparing mean scores in those who experience financial hardship in each study arm versus those who do not.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States