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Financial Navigation Program Intervention in Supporting Patients With Solid Tumors and Their Caregivers

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775616
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : May 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 program intervention works in supporting patients with solid tumors and their caregivers. The financial navigation program intervention is an educational course about cancer treatment cost. This educational course may provide cancer patients and their caregivers with helpful information about dealing with cancer treatment cost.

Condition or disease Intervention/treatment Phase
Caregiver Solid Neoplasm Other: Educational Intervention Other: Questionnaire Administration Other: Quality-of-Life Assessment Not Applicable

Detailed Description:
Participants receive financial navigation program intervention consisting of a financial navigation video, monthly one-one financial counselling session, monthly phone or email consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development of a Comprehensive Financial Navigation Program for Patients With Cancer and Their Caregivers
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Supportive (financial navigation program)
Participants receive financial navigation program intervention consisting of a financial navigation video, monthly one-one financial counselling session, monthly phone or email consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and 12 months.
Other: Educational Intervention
Receive financial navigation program intervention
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Questionnaire Administration
Ancillary studies

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




Primary Outcome Measures :
  1. Accrual rate (number of patients and caregivers enrolled per month) [ Time Frame: Up to 12 months ]
  2. Time to accrual [ Time Frame: Up to 12 months ]
  3. Proportion of participants completing each of the 3 program components [ Time Frame: Up to 12 months ]
  4. Proportion of participants completing the entire program and 6 month follow up [ Time Frame: Up to 6 months ]
  5. Financial status assessment [ Time Frame: Up to 12 months ]
    Prior to and following participation in the financial navigation program, patients will complete questionnaire and provide basic information about their financial status including household income, assets, educational level, and employment status.

  6. Financial distress assessment questionnaire [ Time Frame: Up to 12 months ]
    Will measure patients' level of financial distress before and after participation in various components of the program via a questionnaire that indicates financial distress based on responses

  7. Patient advocate foundation (PAF) navigators [ Time Frame: Up to 12 months ]
    PAF navigators will tract all issues identified during an initial need assessment with the patients and subsequently all outcomes of any such issues.

  8. Consumer education and training services (CENTS) financial counselors [ Time Frame: Up to 12 months ]
    The CENTs financial counselors will tract specific recommendations given each patient during the course of the study and share these recommendation with the investigators.

  9. Family Reach staff feedback [ Time Frame: Up to 12 months ]
    Family Reach will track patients that have been granted financial assistance, and will provide any further information obtained from patients interaction.



Information from the National Library of Medicine

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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:

  • PATIENTS: Any solid tumor diagnosis (any stage)
  • PATIENTS: Currently receiving (or completed within 6 months) chemotherapy, radiation, or hormonal therapy for cancer
  • PATIENTS: In the treating physician's best estimation, has a life expectancy of 6 months or greater
  • PATIENTS: Able to identify a primary caregiver who is involved in helping with the logistics, financial, or emotional aspects of his/her cancer care
  • PATIENTS: English-speaking
  • CAREGIVERS: Caregiver of a patient who is eligible for to participate in the study
  • CAREGIVERS: English-speaking

Exclusion Criteria:

  • PATIENTS: Cognitive or other impairment that would interfere with ability to understand and/or respond to questions about personal finances and paying for cancer treatment
  • PATIENTS: Hematologic malignancy (e.g. multiple myeloma, lymphoma, leukemia)
  • CAREGIVERS: cognitive or other impairment that would interfere with ability to understand and/or respond to questions about patient fiances and paying for cancer treatment

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): NCT03775616


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
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: NCT03775616    
Other Study ID Numbers: RG1001593
NCI-2018-02607 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8570 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 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