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

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ClinicalTrials.gov Identifier: NCT03986502
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Caregiver Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Other: Media Intervention Other: Informational Intervention Other: Best Practice Other: Questionnaire Administration Other: Quality-of-Life Assessment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Randomized Study of a Proactive Financial Navigation Intervention in Patients With Newly Diagnosed Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Estimated Study Start Date : September 19, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: 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.
Other: Media Intervention
Watch web-based financial literacy video

Other: Informational Intervention
Receive information on financial counseling and medical cost assistance

Other: Questionnaire Administration
Ancillary studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Active Comparator: Arm II (usual care)
Patients and caregivers participate in usual clinic procedures and utilize any available clinic or community-based financial resources.
Other: Best Practice
Utilize usual clinic procedures and clinic or community-based financial resources
Other Names:
  • standard of care
  • standard therapy

Other: Questionnaire Administration
Ancillary studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  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: European Quality of Life (EuroQOL) EQ-5D index [ Time Frame: Baseline up to 6 months ]
    Assessed using Composite score from the European Quality of Life (EuroQOL) EQ-5D index. The proportion of patients in each arm who experience improved, unchanged, or worsened EQ-5D scores from baseline to 3 (and 6) months will be compared using Fisher's exact test. Mean score changes from baseline will be compared using two group t tests. A multivariate linear regression model, with worsening score as the dependent variable and study arm (intervention vs. control) as the independent variable will be performed, adjusting for covariates.

  3. Subjective financial distress [ Time Frame: Baseline up to 6 months ]
    Assessed using Comprehensive Score for Financial Toxicity-Patient Reported Outcome Measure. 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: Caregiver Oncology Quality of Life Questionnaire (CarGOQoL) scores [ Time Frame: Baseline up to 6 months ]
    Will determine the proportion of caregivers in each arm who experience improved, unchanged, or worsened Caregiver Oncology Quality of Life Questionnaire (CarGOQoL) scores (composite and sub-score) from baseline to 3 (and 6) months and compare using Fisher's exact test. Mean score changes will be compared using two group t tests. A multivariate linear regression model, with worsening score as the dependent variable and study arm as the independent variable will be performed, adjusting for covariates.

  6. Caregiver burden [ Time Frame: Baseline up to 6 months ]
    Assessed using Burden subscale of the CarGOQoL.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PATIENT: English-speaking
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986502


Contacts
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Contact: Veena Shankaran 206-667-7844 vshank@uw.edu

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Veena Shankaran    206-667-7844    vshank@uw.edu   
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Veena Shankaran Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03986502     History of Changes
Other Study ID Numbers: RG1005389
NCI-2019-03381 ( Registry Identifier: NCI / CTRP )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases