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

NCT03775616 | Completed

• 3 other identifiers: RG1001593NCI-2018-026078570
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver; Solid Neoplasm

Outcome Measures

Primary Outcomes (9)

• Accrual rate (number of patients and caregivers enrolled per month)

  Up to 12 months

• Time to accrual

  Up to 12 months

• Proportion of participants completing each of the 3 program components

  Up to 12 months

• Proportion of participants completing the entire program and 6 month follow up

  Up to 6 months

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Supportive (financial navigation program)

EXPERIMENTAL

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; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Interventions

Educational Intervention OTHER

Receive financial navigation program intervention

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive (financial navigation program)

Questionnaire Administration OTHER

Ancillary studies

Supportive (financial navigation program)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive (financial navigation program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Veena Shankaran

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 14, 2018
• Study Start: November 15, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)