Breast NeoplasmCOST-FINNCT06630962
Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care
A study testing Financial Navigation Program in people with Breast Neoplasm and Prostate Neoplasm, run by Northwestern University at 2 sites in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm, Prostate Neoplasm, Colon Neoplasm
- What is being tested?
- Financial Navigation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesNigeria
- Study dates
- 15 Jul 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide consent
- Has initiated definitive cancer treatment at the study site or elsewhere in the past
- Only receiving best supportive care
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites, 2 recruiting
- Recruiting
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife
Isaiah Oyewole
Funmilola Wuraola
- Recruiting
Lakeshore Cancer Center
Lagos
Bindiya Sadarangani
Chinenye Iwuji
About this study
Official title: Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care: A Randomized Control Trial- COST-FIN
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:
Read more
- If a financial navigation program can effectively and significantly reduce financial catastrophe and distress for cancer patients in Nigeria?
- If a financial navigation program is financially sustainable and cost-effective for cancer centers in Nigeria?
Participants will be required to:
- Complete surveys about their demographics, clinical history, and socioeconomic status
- Complete questionnaires about their quality of life and psychological wellbeing
- 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.
Read the detailed description
Over 100,000 individuals are diagnosed with cancer annually in Nigeria, the highest burden out of all countries in sub-Saharan Africa (SSA). Treatment options are limited and often delayed due to lack of insurance coverage and high out-of-pocket costs, which is devastating for Nigeria's 83 million living in poverty (40% of the population). Importantly, it is estimated that 77-94% of cancer patients in SSA face financial catastrophe (FC) where health expenses exceed 25% of household expenditure, 40% of non-subsistence expenditures, or 10% of household income.
While Nigeria has recently planned to invest 300 billion USD in the National Cancer Control Plan, a comprehensive initiative to centralize and strengthen multidisciplinary cancer care, high-quality research on innovative methods to eliminate cost barriers and make treatment affordable is needed.
In the United States, structured financial navigation programs (FNP) have been successful in helping patients finance their cancer care, and save costs, and have been associated with reduced levels of financial distress. However, there is paucity of data high-quality on the effectiveness of an FNP for cancer care in SSA.
The proposed study will investigate the effectiveness of an FNP in reducing financial catastrophe and distress for cancer patients in Nigeria. The FNP will hire financial navigators (FNs) at the cancer centers to educate patients on financial literacy, enroll patients in insurance, and find alternative funding sources, such as charitable solutions. The randomized control trial will enroll 200 newly diagnosed breast, colorectal, or prostate cancer patients at two cancer centers in Lagos, Nigeria, and investigate the impact of the FNP on:
- The incidence of financial catastrophe
- Financial distress
- Budget and financial sustainability analysis of the FNP -- by conducting a cost-effectiveness analysis by comparing the program's cost to the benefits in terms of funding secured and number of participants enrolled in insurance.
This study -- the first of its kind in SSA -- will inform the potential for FNPs to reduce the financial burden of cancer treatment in resource-constrained settings. If effective, programs like this would serve as an invaluable resource to increase access to care and in turn improve cancer outcomes in the region.
In light of Nigerian government's recently renewed interest in improving access to cancer care, findings from this study will be crucial in health policy reform. Further, this study's findings will inform and influence cancer care in SSA, and will prompt effectiveness in other similar contexts.
Finally, if found to be effective, data from this investigation will lay the foundation to support an R01-level study to comprehensively evaluate the implementation and adoption of FNPs in Nigeria and other parts of SSA.
- Conditions
- Breast Neoplasm, Prostate Neoplasm, Colon Neoplasm, Rectal Neoplasm
- Being tested
- Financial Navigation Program
- 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
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Navigation ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to 3, 6 and 12 months
Secondary 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.
Measured: From enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliet Lumati, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630962
- Sponsor's protocol ID
- STU00221204
- Acronym
- COST-FIN
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic, socioeconomic, clinical, cost, and patient-reported outcome data will be uploaded and shared for each enrolled participant. All data will be de-identified and dates will be excluded from the dataset.
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338The Lancet. GLOBOCAN 2018: counting the toll of cancer. Lancet. 2018 Sep 22;392(10152):985. doi: 10.1016/S0140-6736(18)32252-9. Epub 2018 Sep 20. No abstract available.
PubMed 30264708Awodutire PO, Kolawole OA, Ilori OR. Data on the survival times of breast cancer patients in a Teaching Hospital, Osogbo. Data Brief. 2020 Aug 1;32:106109. doi: 10.1016/j.dib.2020.106109. eCollection 2020 Oct.
PubMed 32817870Ali-Gombe M, Mustapha MI, Folasire A, Ntekim A, Campbell OB. Pattern of survival of breast cancer patients in a tertiary hospital in South West Nigeria. Ecancermedicalscience. 2021 Feb 25;15:1192. doi: 10.3332/ecancer.2021.1192. eCollection 2021.
PubMed 33889201Gullickson C, Goodman M, Joko-Fru YW, Gnangnon FHR, N'Da G, Woldegeorgis MA, Buziba NG, Karugu C, Manraj SS, Lorenzoni CF, Hansen R, Finesse A, Somdyala NIM, Bukirwa P, Chingonzoh T, Chokunonga E, Liu B, Kantelhardt E, Parkin DM, Jemal A. Colorectal cancer survival in sub-Saharan Africa by age, stage at diagnosis and Human Development Index: A population-based registry study. Int J Cancer. 2021 Oct 15;149(8):1553-1563. doi: 10.1002/ijc.33715. Epub 2021 Jul 21.
PubMed 34164808Saluja S, Alatise OI, Adewale A, Misholy J, Chou J, Gonen M, Weiser M, Kingham TP. A comparison of colorectal cancer in Nigerian and North American patients: is the cancer biology different? Surgery. 2014 Aug;156(2):305-10. doi: 10.1016/j.surg.2014.03.036. Epub 2014 Jun 19.
PubMed 24953266Seraphin TP, Joko-Fru WY, Manraj SS, Chokunonga E, Somdyala NIM, Korir A, N'Da G, Finesse A, Wabinga H, Assefa M, Gnangnon F, Hansen R, Buziba NG, Liu B, Kantelhardt EJ, Parkin DM. Prostate cancer survival in sub-Saharan Africa by age, stage at diagnosis, and human development index: a population-based registry study. Cancer Causes Control. 2021 Sep;32(9):1001-1019. doi: 10.1007/s10552-021-01453-x. Epub 2021 Jul 10.
PubMed 34244896Ekeke O, Amusan O, Eke N. Management of prostate cancer in port harcourt, Nigeria: changing patterns. J West Afr Coll Surg. 2012 Jul;2(3):58-77.
PubMed 25452994Araghi M, Arnold M, Rutherford MJ, Guren MG, Cabasag CJ, Bardot A, Ferlay J, Tervonen H, Shack L, Woods RR, Saint-Jacques N, De P, McClure C, Engholm G, Gavin AT, Morgan E, Walsh PM, Jackson C, Porter G, Moller B, Bucher O, Eden M, O'Connell DL, Bray F, Soerjomataram I. Colon and rectal cancer survival in seven high-income countries 2010-2014: variation by age and stage at diagnosis (the ICBP SURVMARK-2 project). Gut. 2021 Jan;70(1):114-126. doi: 10.1136/gutjnl-2020-320625. Epub 2020 Jun 1.
PubMed 32482683Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.
PubMed 29395269Mustapha MI, Ali-Gombe M, Abdullahi A, Adenipekun A, Campbell OB. Financial Burden of Cancer on Patients Treated at a Tertiary Health Facility in South West Nigeria. J West Afr Coll Surg. 2020 Oct-Dec;10(4):23-29. doi: 10.4103/jwas.jwas_4_22. Epub 2022 Jun 8.
PubMed 35814963Sharma A, Alatise OI, Adisa AO, Arowolo OA, Olasehinde O, Famurewa OC, Omisore AD, Komolafe AO, Olaofe O, Katung AI, Ibikunle AD, Egberongbe AA, Olatoke SA, Agodirin SO, Adesiyun AO, Adeyeye A, Ibrahim K, Kolawole OA, Idris OL, Adejumobi MO, Ajayi AI, Olakanmi AO, Constable JC, Seier K, Gonen M, Brennan MF, Kingham TP. Treatment of colorectal cancer in Sub-Saharan Africa: Results from a prospective Nigerian hospital registry. J Surg Oncol. 2020 Feb;121(2):342-349. doi: 10.1002/jso.25768. Epub 2019 Nov 19.
PubMed 31742699Sharma A, Alatise OI, O'Connell K, Ogunleye SG, Aderounmu AA, Samson ML, Wuraola F, Olasehinde O, Kingham TP, Du M. Healthcare utilisation, cancer screening and potential barriers to accessing cancer care in rural South West Nigeria: a cross-sectional study. BMJ Open. 2021 Jul 26;11(7):e040352. doi: 10.1136/bmjopen-2020-040352.
PubMed 34312189Fapohunda A, Fakolade A, Omiye J, Afolaranmi O, Arowojolu O, Oyebamiji T, Nwogu C, Olawaiye A, Mutiu J. Cancer presentation patterns in Lagos, Nigeria: Experience from a private cancer center. J Public Health Afr. 2020 Dec 31;11(2):1138. doi: 10.4081/jphia.2020.1138. eCollection 2020 Dec 31.
PubMed 33623651Knapp GC, Wuraola FO, Olasehinde O, Romanoff A, Kingham PT, Alatise OI. The out-of-pocket cost of breast cancer care at a public tertiary care hospital in Nigeria: an exploratory analysis. Pan Afr Med J. 2022 Apr 5;41:272. doi: 10.11604/pamj.2022.41.272.24610. eCollection 2022.
PubMed 35784593
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Financial Navigation on Financial Catastrophe and Distress for Cancer Care: A Randomized Control Trial- COST-FIN
- ClinicalTrials.gov ID
- NCT06630962
- Acronym / sponsor ID
- COST-FIN / STU00221204
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- If a financial navigation program can effectively and significantly reduce financial catastrophe and distress for cancer patients in Nigeria?
- If a financial navigation program is financially sustainable and cost-effective for cancer centers in Nigeria?
Participants will be required to:
- Complete surveys about their demographics, clinical history, and socioeconomic status
- Complete questionnaires about their quality of life and psychological wellbeing
- 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.
Detailed description
Over 100,000 individuals are diagnosed with cancer annually in Nigeria, the highest burden out of all countries in sub-Saharan Africa (SSA). Treatment options are limited and often delayed due to lack of insurance coverage and high out-of-pocket costs, which is devastating for Nigeria's 83 million living in poverty (40% of the population). Importantly, it is estimated that 77-94% of cancer patients in SSA face financial catastrophe (FC) where health expenses exceed 25% of household expenditure, 40% of non-subsistence expenditures, or 10% of household income.
While Nigeria has recently planned to invest 300 billion USD in the National Cancer Control Plan, a comprehensive initiative to centralize and strengthen multidisciplinary cancer care, high-quality research on innovative methods to eliminate cost barriers and make treatment affordable is needed.
In the United States, structured financial navigation programs (FNP) have been successful in helping patients finance their cancer care, and save costs, and have been associated with reduced levels of financial distress. However, there is paucity of data high-quality on the effectiveness of an FNP for cancer care in SSA.
The proposed study will investigate the effectiveness of an FNP in reducing financial catastrophe and distress for cancer patients in Nigeria. The FNP will hire financial navigators (FNs) at the cancer centers to educate patients on financial literacy, enroll patients in insurance, and find alternative funding sources, such as charitable solutions. The randomized control trial will enroll 200 newly diagnosed breast, colorectal, or prostate cancer patients at two cancer centers in Lagos, Nigeria, and investigate the impact of the FNP on:
- The incidence of financial catastrophe
- Financial distress
- Budget and financial sustainability analysis of the FNP -- by conducting a cost-effectiveness analysis by comparing the program's cost to the benefits in terms of funding secured and number of participants enrolled in insurance.
This study -- the first of its kind in SSA -- will inform the potential for FNPs to reduce the financial burden of cancer treatment in resource-constrained settings. If effective, programs like this would serve as an invaluable resource to increase access to care and in turn improve cancer outcomes in the region.
In light of Nigerian government's recently renewed interest in improving access to cancer care, findings from this study will be crucial in health policy reform. Further, this study's findings will inform and influence cancer care in SSA, and will prompt effectiveness in other similar contexts.
Finally, if found to be effective, data from this investigation will lay the foundation to support an R01-level study to comprehensively evaluate the implementation and adoption of FNPs in Nigeria and other parts of SSA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Financial Navigation Arm | Experimental | Other: Financial Navigation ProgramA 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to provide consent
- Has initiated definitive cancer treatment at the study site or elsewhere in the past
- Only receiving best supportive care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial Navigation ProgramA 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. | Other | Financial Navigation Arm |
Primary outcome
Incidence of financial catastrophe (FC)
Time frame: From enrollment to 12 months
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.
Levels of financial distress (FD)
Time frame: From enrollment to 3, 6 and 12 months
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.
1 secondary outcome
Rate of cost-related non-adherence
Time frame: From enrollment to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 30264708The Lancet. GLOBOCAN 2018: counting the toll of cancer. Lancet. 2018 Sep 22;392(10152):985. doi: 10.1016/S0140-6736(18)32252-9. Epub 2018 Sep 20. No abstract available.
- Background: PubMed 32817870Awodutire PO, Kolawole OA, Ilori OR. Data on the survival times of breast cancer patients in a Teaching Hospital, Osogbo. Data Brief. 2020 Aug 1;32:106109. doi: 10.1016/j.dib.2020.106109. eCollection 2020 Oct.
- Background: PubMed 33889201Ali-Gombe M, Mustapha MI, Folasire A, Ntekim A, Campbell OB. Pattern of survival of breast cancer patients in a tertiary hospital in South West Nigeria. Ecancermedicalscience. 2021 Feb 25;15:1192. doi: 10.3332/ecancer.2021.1192. eCollection 2021.
- Background: PubMed 34164808Gullickson C, Goodman M, Joko-Fru YW, Gnangnon FHR, N'Da G, Woldegeorgis MA, Buziba NG, Karugu C, Manraj SS, Lorenzoni CF, Hansen R, Finesse A, Somdyala NIM, Bukirwa P, Chingonzoh T, Chokunonga E, Liu B, Kantelhardt E, Parkin DM, Jemal A. Colorectal cancer survival in sub-Saharan Africa by age, stage at diagnosis and Human Development Index: A population-based registry study. Int J Cancer. 2021 Oct 15;149(8):1553-1563. doi: 10.1002/ijc.33715. Epub 2021 Jul 21.
- Background: PubMed 24953266Saluja S, Alatise OI, Adewale A, Misholy J, Chou J, Gonen M, Weiser M, Kingham TP. A comparison of colorectal cancer in Nigerian and North American patients: is the cancer biology different? Surgery. 2014 Aug;156(2):305-10. doi: 10.1016/j.surg.2014.03.036. Epub 2014 Jun 19.
- Background: PubMed 34244896Seraphin TP, Joko-Fru WY, Manraj SS, Chokunonga E, Somdyala NIM, Korir A, N'Da G, Finesse A, Wabinga H, Assefa M, Gnangnon F, Hansen R, Buziba NG, Liu B, Kantelhardt EJ, Parkin DM. Prostate cancer survival in sub-Saharan Africa by age, stage at diagnosis, and human development index: a population-based registry study. Cancer Causes Control. 2021 Sep;32(9):1001-1019. doi: 10.1007/s10552-021-01453-x. Epub 2021 Jul 10.
- Background: PubMed 25452994Ekeke O, Amusan O, Eke N. Management of prostate cancer in port harcourt, Nigeria: changing patterns. J West Afr Coll Surg. 2012 Jul;2(3):58-77.
- Background: PubMed 32482683Araghi M, Arnold M, Rutherford MJ, Guren MG, Cabasag CJ, Bardot A, Ferlay J, Tervonen H, Shack L, Woods RR, Saint-Jacques N, De P, McClure C, Engholm G, Gavin AT, Morgan E, Walsh PM, Jackson C, Porter G, Moller B, Bucher O, Eden M, O'Connell DL, Bray F, Soerjomataram I. Colon and rectal cancer survival in seven high-income countries 2010-2014: variation by age and stage at diagnosis (the ICBP SURVMARK-2 project). Gut. 2021 Jan;70(1):114-126. doi: 10.1136/gutjnl-2020-320625. Epub 2020 Jun 1.
- Background: PubMed 29395269Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.
- Background: PubMed 35814963Mustapha MI, Ali-Gombe M, Abdullahi A, Adenipekun A, Campbell OB. Financial Burden of Cancer on Patients Treated at a Tertiary Health Facility in South West Nigeria. J West Afr Coll Surg. 2020 Oct-Dec;10(4):23-29. doi: 10.4103/jwas.jwas_4_22. Epub 2022 Jun 8.
- Background: PubMed 31742699Sharma A, Alatise OI, Adisa AO, Arowolo OA, Olasehinde O, Famurewa OC, Omisore AD, Komolafe AO, Olaofe O, Katung AI, Ibikunle AD, Egberongbe AA, Olatoke SA, Agodirin SO, Adesiyun AO, Adeyeye A, Ibrahim K, Kolawole OA, Idris OL, Adejumobi MO, Ajayi AI, Olakanmi AO, Constable JC, Seier K, Gonen M, Brennan MF, Kingham TP. Treatment of colorectal cancer in Sub-Saharan Africa: Results from a prospective Nigerian hospital registry. J Surg Oncol. 2020 Feb;121(2):342-349. doi: 10.1002/jso.25768. Epub 2019 Nov 19.
- Partner site listing related materials to our study and patient enrollmentLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Demographic, socioeconomic, clinical, cost, and patient-reported outcome data will be uploaded and shared for each enrolled participant. All data will be de-identified and dates will be excluded from the dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliet Lumati principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Navigation Program in people with Breast Neoplasm and Prostate Neoplasm, run by Northwestern University at 2 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliet Lumati (+1 312 926 4230, juliet.lumati@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of financial catastrophe (FC) (time frame: From enrollment to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06630962, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.