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

Not Applicable

Completed

• Conditions: Caregiver; Solid Neoplasm
• Interventions: Other: Educational Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

• Registration Number: NCT03775616
• Lead Sponsor: Fred Hutchinson Cancer 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.

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 Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-14
• Status Verified: 2019-05
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive (financial navigation program)	Quality-of-Life Assessment	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.
Supportive (financial navigation program)	Educational Intervention	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.
Supportive (financial navigation program)	Questionnaire Administration	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States