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

NCT ID: NCT03986502

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-22

Study Completion Date

2022-10-01

Brief Summary

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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

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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.

Conditions

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Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Media Intervention

Intervention Type OTHER

Watch web-based financial literacy video

Informational Intervention

Intervention Type OTHER

Receive information on financial counseling and medical cost assistance

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

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

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Media Intervention

Watch web-based financial literacy video

Intervention Type OTHER

Informational Intervention

Receive information on financial counseling and medical cost assistance

Intervention Type OTHER

Best Practice

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

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veena Shankaran

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38400905 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2019-03381

Identifier Type: REGISTRY

Identifier Source: secondary_id

10200

Identifier Type: OTHER

Identifier Source: secondary_id

RG1005389

Identifier Type: -

Identifier Source: org_study_id

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