Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care

NCT06630962 | Recruiting DMC

• 1 other identifier: STU00221204
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.If a financial navigation program can effectively and significantly reduce financial catastrophe and distress for cancer patients in Nigeria?
2. 2.If a financial navigation program is financially sustainable and cost-effective for cancer centers in Nigeria?
3. 3.Complete surveys about their demographics, clinical history, and socioeconomic status
4. 4.Complete questionnaires about their quality of life and psychological wellbeing
5. 5.Report all costs related to their cancer care

Conditions

Breast Neoplasm; Prostate Neoplasm; Colon Neoplasm; Rectal Neoplasm

Keywords

Financial Navigation; Financing Cancer Care; Nigeria; Breast Neoplasm; Prostate Neoplasm; Colon Neoplasm; Rectal Neoplasm; Health Insurance; Randomized Control Trial; Healthcare Cost; Health Expenditure; Financial Risk Sharing; Universal Health Insurance; National Health Insurance Scheme; Catastrophic Health Spending; Financial Distress; Sub-Saharan Africa; Health Plan Implementation; Global Health; Healthcare Economics and Organizations; Clinical Oncology; Cancer Care Facilities; Surgical Oncology; Global Burden of Disease; Social Determinants of Health; Health Impact Assessment

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to 12 months

• 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.

  From enrollment to 3, 6 and 12 months

Secondary Outcomes (1)

• Rate of cost-related non-adherence

  From enrollment to 6 months

Study Arms (2)

Financial Navigation Arm

EXPERIMENTAL

A financial navigator will educate these 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.

Other: Financial Navigation Program

Routine Care Arm

NO INTERVENTION

Participants will not have access to the services of the financial navigator. Financial counseling and assistance will be limited to what is routinely provided by the cancer center.

Interventions

Financial Navigation Program OTHER

A 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.

Financial Navigation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide consent
• Has initiated definitive cancer treatment at the study site or elsewhere in the past
• Only receiving best supportive care

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Nigeria

RECRUITING

Lakeshore Cancer Center

Lagos, Nigeria

RECRUITING

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Related Links

• Partner site listing related materials to our study and patient enrollment

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Juliet Lumati

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliet Lumati

CONTACT

+1 312 926 4230; juliet.lumati@northwestern.edu

Kristina Diaz

CONTACT

2027253279; kristina.diaz@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Potential Crossover: An interim analysis will be conducted once 50% of the recruitment target (100 participants total) have completed at least 6-months of follow-up, which is estimated to occur at approximately 1 year from start of the study. If significant differences between the Financial Navigation Program (FNP) and routine care arms are observed, all enrolled participants in the control arm will be given access to the FNP. Endpoint-related data will be collected until study completion (1-year follow-up for all enrolled participants).

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 8, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be shared at study conclusion, once all analyses are complete. The data will be available to the wider research community indefinitely.
• Access Criteria: Data will be accessible to anyone in the wider research community via the clinicaltrials.gov repository. The data will be identifiable through a unique identification code assigned by clinicaltrials.gov.

Locations

NG (2)