Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
The goal of this study is to investigate the effectiveness of a structured financial navigation program in reducing financial catastrophe and financial distress for cancer patients in Nigeria.
The main study questions being investigated are:
1. If a financial navigation program can effectively and significantly reduce financial catastrophe and distress for cancer patients in Nigeria? 2. If a financial navigation program is financially sustainable and cost-effective for cancer centers in Nigeria?
Participants will be required to:
1. Complete surveys about their demographics, clinical history, and socioeconomic status 2. Complete questionnaires about their quality of life and psychological wellbeing 3. Report all costs related to their cancer care
Investigators will compare participants in the financial navigation program and those not in the financial navigation program to identify potential differences in catastrophic health expenditure and financial distress.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and older
Recently diagnosed with breast, colorectal or prostate cancer within 6 weeks of presentation at the study site
Have not received definitive chemotherapy, radiotherapy, or undergone major surgery (diagnostic or temporary interventions, such as excisional biopsy or temporary colostomy may still enroll)
Candidate for definitive cancer treatment
Disqualifiers
Unable to provide consent
Has initiated definitive cancer treatment at the study site or elsewhere in the past
Only receiving best supportive care
Trial design
Design model
Parallel
Treatments tested in this trial
Financial Navigation Program
Other interventionA salaried financial navigator will be hired by the study sites. All responsibilities of the navigator will revolve around the structured financial navigation program. There is currently no research indicating that such a role has been incorporated at cancer centers in sub-Saharan Africa. Through this program, the financial navigator will educate participants on financial literacy, insurance plans and payment options available through charities and financial assistance programs. In addition to providing financial counseling, the financial navigator will verify participant insurance documents, maintain records of financial agreements, and coordinate payments with insurance companies.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Financial Navigation ArmExperimental treatment 1 intervention
Group B: Routine Care ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of financial catastrophe (FC)
To compare the incidence of FC between participants in the financial navigation program (FNP) and control arms. FC is defined as treatment-related costs that exceed 10% of household income (HHI), 25% of total household expenditure (HHE), or 40% of non-essential household spending (HSE). All direct and indirect out-of-pocket (OOP) costs of cancer care will be summed for each participant and represented as a proportion of HHI, HHE, and HSE.
Time frame
From enrollment to 12 months2
Levels of financial distress (FD)
To compare the levels of FD experienced between participants in the FNP and control arms. Financial Distress (FD) will be measured using the FACIT-COST tool, a validated patient-reported measure with scores ranging from 0-44 (higher scores represent better financial well-being). FACIT-COST scores will be assessed for all participants at 3, 6, and 12 months from enrollment, and mean scores at 6 months will be compared between both study arms.
Time frame
From enrollment to 3, 6 and 12 monthsSecondary outcomes
1
Rate of cost-related non-adherence
Exploratory analysis to compare the rates of treatment non-adherence related to treatment costs between the FNP and control arms. Data on adherence and reasons for non-adherence will be collected through structured interviews with participants and their treating medical oncologists 6 months post-enrollment.
Time frame
From enrollment to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov