Financial Navigation Program Intervention in Supporting Patients With Solid Tumors and Their Caregivers
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|ClinicalTrials.gov Identifier: NCT03775616|
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Caregiver Solid Neoplasm||Other: Educational Intervention Other: Questionnaire Administration Other: Quality-of-Life Assessment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Development of a Comprehensive Financial Navigation Program for Patients With Cancer and Their Caregivers|
|Actual Study Start Date :||November 15, 2017|
|Actual Primary Completion Date :||May 15, 2019|
|Actual Study Completion Date :||May 15, 2019|
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: Educational Intervention
Receive financial navigation program intervention
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Accrual rate (number of patients and caregivers enrolled per month) [ Time Frame: Up to 12 months ]
- Time to accrual [ Time Frame: Up to 12 months ]
- Proportion of participants completing each of the 3 program components [ Time Frame: Up to 12 months ]
- Proportion of participants completing the entire program and 6 month follow up [ Time Frame: 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.
- 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
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775616
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Veena Shankaran||Fred Hutch/University of Washington Cancer Consortium|