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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Media Intervention; Watch web-based financial literacy video; Other: Informational Intervention; Receive information on financial counseling and medical cost assistance
ACTIVE_COMPARATOR: Arm II (usual care); 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: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Utilize usual clinic procedures and clinic or community-based financial resources; Other Names: standard of care; standard therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Veena Shankaran, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2021
• Primary Completion (ACTUAL): October 1, 2022
• Study Completion (ACTUAL): October 1, 2022

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Esophageal Neoplasms
• Other Study ID Numbers: RG1005389; 10200 (Other Identifier: CTEP); NCI-2019-03381 (REGISTRY: NCI / CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No