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Completed

NCT Number: NCT03986502

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

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Key information

Conditions

Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Media Intervention

Other

Watch web-based financial literacy video

Informational intervention

Other

Receive information on financial counseling and medical cost assistance

Best Practice

Other

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

Other names: standard of care, standard therapy

Questionnaire Administration

Other

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

  1. Number of Participants that have experienced Household financial hardship

    Time frame: 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%

  2. Patient quality of life: FACT-G

    Time frame: Baseline up to 6 months

    Composite score from the FACT-G. A 6-point score change is considered clinically meaningful in US cancer populations.

  3. Subjective financial distress

    Time frame: 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.

  4. Qualitative assessment of usual care and intervention

    Time frame: 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.

  5. Caregiver quality of life

    Time frame: 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.

  6. Caregiver burden

    Time frame: Baseline up to 6 months

    Assessed via the social well-being subscale of the City of Hope Quality of Life questionnaire.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2019
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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