Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Conditions
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.
Interventions
OTHERMedia Intervention
Watch web-based financial literacy video
OTHERInformational Intervention
Receive information on financial counseling and medical cost assistance
OTHERBest Practice
Utilize usual clinic procedures and clinic or community-based financial resources
OTHERQuestionnaire Administration
Ancillary studies
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
Eli Lilly and Company
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
| 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. |
| 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. |
| 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. |
| Caregiver burden | Baseline up to 6 months | Assessed via the social well-being subscale of the City of Hope Quality of Life questionnaire. |
Countries
United States
Outcome results
None listed