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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Randomized Study of a Proactive Financial Navigation Intervention in Patients With Newly Diagnosed Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Conditions
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Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Intervention / Treatment
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* Other: Media Intervention
* Other: Informational Intervention
* Other: Best Practice
* Other: Questionnaire Administration
* Other: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: • PATIENT: Enrolled in hospice care at the time of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (financial navigation program)<br>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. | Other: Media Intervention<br>* Watch web-based financial literacy video<br>Other: Informational Intervention<br>* Receive information on financial counseling and medical cost assistance<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|
| Active Comparator: Arm II (usual care)<br>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. | Other: Best Practice<br>* Utilize usual clinic procedures and clinic or community-based financial resources<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants that have experienced Household financial hardship | Financial Hardship is defined as self-report of accrual of debt, taking out loans for cancer treatment or decline in household income <=20% | Up to 6 months | 
| Patient quality of life: FACT-G | Composite score from the FACT-G. A 6-point score change is considered clinically meaningful in US cancer populations. | Baseline up to 6 months | 
| Subjective financial distress | 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. | Baseline up to 6 months | 
| Qualitative assessment of usual care and intervention | 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. | Up to 6 months | 
| Caregiver quality of life | 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. | Baseline up to 6 months | 
| Caregiver burden | Assessed via the social well-being subscale of the City of Hope Quality of Life questionnaire. | Baseline up to 6 months |