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Gastric AdenocarcinomaNCT03986502

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

A study testing Media Intervention, Informational Intervention and Best Practice in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Media Intervention, Informational Intervention and Best Practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
22 Jan 2021to 1 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • PATIENT: Enrolled in hospice care at the time of enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

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

Read the 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.

Being tested
Media Intervention, Informational Intervention, Best Practice, Questionnaire Administration, Quality-of-Life Assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Media InterventionOther

    Watch web-based financial literacy video

  • Informational InterventionOther

    Receive information on financial counseling and medical cost assistance

  • Best PracticeOther

    Also called standard of care, standard therapy

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

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT03986502
Study groupRoleWhat they receive
Arm I (financial navigation program)ExperimentalPatients 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.
Receives: Other: Media Intervention; Other: Informational Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment
Arm II (usual care)Active comparatorPatients 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.
Receives: Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants that have experienced Household financial hardship

    Financial Hardship is defined as self-report of accrual of debt, taking out loans for cancer treatment or decline in household income <=20%

    Measured: Up to 6 months

  2. Patient quality of life: FACT-G

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

    Measured: Baseline up to 6 months

  3. Subjective financial distress

    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.

    Measured: Baseline up to 6 months

  4. Qualitative assessment of usual care and intervention

    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.

    Measured: Up to 6 months

  5. Caregiver quality of life

    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.

    Measured: Baseline up to 6 months

  6. Caregiver burden

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

    Measured: Baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2019
  2. Study start22 Jan 2021
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03986502
Sponsor's protocol ID
RG1005389
Other IDs
NCI-2019-03381, 10200
Status last verified
Oct 2022
First submitted
10 Jun 2019
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38400905

Questions about this trial

What is this clinical trial studying?

A study testing Media Intervention, Informational Intervention and Best Practice in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants that have experienced Household financial hardship (time frame: Up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03986502, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

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