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

May 16, 2019 updated by: Fred Hutchinson Cancer Center

Development of a Comprehensive Financial Navigation Program for Patients With Cancer and Their Caregivers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Receive financial navigation program intervention
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accrual rate (number of patients and caregivers enrolled per month)
Time Frame: Up to 12 months
Up to 12 months
Time to accrual
Time Frame: Up to 12 months
Up to 12 months
Proportion of participants completing each of the 3 program components
Time Frame: Up to 12 months
Up to 12 months
Proportion of participants completing the entire program and 6 month follow up
Time Frame: Up to 6 months
Up to 6 months
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.
Up to 12 months
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
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Veena Shankaran, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2017

Primary Completion (ACTUAL)

May 15, 2019

Study Completion (ACTUAL)

May 15, 2019

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (ACTUAL)

December 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 16, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • RG1001593
  • NCI-2018-02607 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • 8570 (OTHER: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe