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

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Treatments: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Informational Intervention; Other: Media Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03986502

RG1005389

10200 (Registry Identifier)

NCI-2019-03381 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arm I (financial navigation program)

Experimental group

Description:

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.

Treatment:

Other: Informational Intervention

Other: Quality-of-Life Assessment

Other: Media Intervention

Other: Questionnaire Administration

Arm II (usual care)

Active Comparator group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Best Practice