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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03986502
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date July 31, 2020
Estimated Study Start Date  ICMJE September 15, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • 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%
  • 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.
  • 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.
  • 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.
  • 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.
  • Caregiver burden [ Time Frame: Baseline up to 6 months ]
    Assessed using Burden subscale of the CarGOQoL.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Financial Navigation Intervention in Improving Financial and Clinical Outcomes in Patients With Newly Diagnosed Gastric or Gastroesophageal Junction Adenocarcinoma
Official Title  ICMJE Pilot Randomized Study of a Proactive Financial Navigation Intervention in Patients With Newly Diagnosed Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Caregiver
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
Intervention  ICMJE
  • Other: Media Intervention
    Watch web-based financial literacy video
  • Other: Informational Intervention
    Receive information on financial counseling and medical cost assistance
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Media Intervention
    • Other: Informational Intervention
    • Other: Questionnaire Administration
    • Other: 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.
    Interventions:
    • Other: Best Practice
    • Other: Questionnaire Administration
    • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019)
284
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Veena Shankaran 206-667-7844 vshank@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986502
Other Study ID Numbers  ICMJE RG1005389
NCI-2019-03381 ( Registry Identifier: NCI / CTRP )
10200 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Veena Shankaran Fred Hutch/University of Washington Cancer Consortium
PRS Account Fred Hutchinson Cancer Research Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP