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Completed

NCT Number: NCT03775616

Financial Navigation Program Intervention in Supporting Patients With Solid Tumors 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.

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Key information

Conditions

Caregiver Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive financial navigation program intervention

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Questionnaire Administration

Other

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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