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

NCT03986502 | Completed

• 3 other identifiers: RG1005389NCI-2019-0338110200
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Arm I (financial navigation program)

EXPERIMENTAL

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; Other: Informational Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Arm II (usual care)

ACTIVE COMPARATOR

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; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Interventions

Media Intervention OTHER

Watch web-based financial literacy video

Arm I (financial navigation program)

Informational Intervention OTHER

Receive information on financial counseling and medical cost assistance

Arm I (financial navigation program)

Best Practice OTHER

Utilize usual clinic procedures and clinic or community-based financial resources

Also known as: standard of care, standard therapy

Arm II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (financial navigation program); Arm II (usual care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (financial navigation program); Arm II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Bell-Brown A, Hopkins T, Watabayashi K, Overstreet K, Leahy A, Bradshaw E, Gallagher K, Obenchain J, Padron A, Scott B, Flores B, Shankaran V. A proactive financial navigation intervention in patients with newly diagnosed gastric and gastroesophageal junction adenocarcinoma. Support Care Cancer. 2024 Feb 24;32(3):189. doi: 10.1007/s00520-024-08399-1.

  PMID: 38400905 DERIVED

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Veena Shankaran

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 14, 2019
• Study Start: January 22, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)