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

Caregiver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775616
• Other study ID #: RG1001593
• Secondary ID: NCI-2018-0260785
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2019
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver
• Solid Neoplasm

Intervention

Other:
• Educational Intervention
Receive financial navigation program intervention
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rate (number of patients and caregivers enrolled per month)		Up to 12 months
Primary	Time to accrual		Up to 12 months
Primary	Proportion of participants completing each of the 3 program components		Up to 12 months
Primary	Proportion of participants completing the entire program and 6 month follow up		Up to 6 months
Primary	Financial status assessment	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
Primary	Financial distress assessment questionnaire	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
Primary	Patient advocate foundation (PAF) navigators	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
Primary	Consumer education and training services (CENTS) financial counselors	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
Primary	Family Reach staff feedback	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