Clinical trial NCT03986502: Financial Navigation Intervention in Improving Financial and Clinical Outcomes in Patients With Newly Diagnosed Gastric or Gastroesophageal Junction Adenocarcinoma
Official title: Pilot Randomized Study of a Proactive Financial Navigation Intervention in Patients With Newly Diagnosed Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2019-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants that have experienced Household financial hardship
timeFrame: Up to 6 months
measure: Patient quality of life: FACT-G
timeFrame: Baseline up to 6 months
measure: Subjective financial distress
timeFrame: Baseline up to 6 months
measure: Qualitative assessment of usual care and intervention
timeFrame: Up to 6 months
measure: Caregiver quality of life
timeFrame: Baseline up to 6 months
measure: Caregiver burden
timeFrame: Baseline up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Veena Shankaran
role: PRINCIPAL_INVESTIGATOR
References: