A Prospective Cohort With Patient Navigation as an Intervention for Breast Cancer Patients
NCT ID: NCT06257888
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2024-03-01
2025-05-01
Brief Summary
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* Can patient navigation reduce the duration (in days) between patient admission and the commencement of treatment?
* Does patient navigation influence overall survival rates when juxtaposed with historical cohorts from the local setting? Participants will receive continuous support from a patient navigator starting from admission until the initiation of any oncological treatment.
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Detailed Description
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-Specific Objectives:
* Develop an oncological patient navigation system for breast cancer patients treated at HCM.
* Establish a prospective cohort of navigated breast cancer patients (with invasive or ductal carcinoma in situ) treated at HCM in 2024-25 (recruitment period of twelve months).
* Collect diverse epidemiological data from navigated patients during the proposed study period.
* Describe the following variables: time from first symptom until first medical consultation (in days), time from first medical consultation to cancer diagnosis (in days) and time from diagnosis to first treatment (either surgery or neoadjuvant treatment) in days.
* Compare time from first symptom to diagnosis (in days) and time from diagnosis to first treatment (in days) to a historical cohort published by Brandão M. et al (The Oncologist, 2021).
* Collect overall survival data in this cohort for thirty six months after last patient recruited for future publication.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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breast cancer patients under navigation
breast cancer patients, intervention = patient navigation
patient navigation
two trained patient navigators will admit breast cancer patients to HCM, navigate them from admission to commencement of first treatment and will collect all pertinent epidemiological data and variables
Interventions
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patient navigation
two trained patient navigators will admit breast cancer patients to HCM, navigate them from admission to commencement of first treatment and will collect all pertinent epidemiological data and variables
Eligibility Criteria
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Inclusion Criteria
* 18 years and older
* will undergo breast cancer treatment at HCM
* consent to participate
Exclusion Criteria
* less than18 years of age
* history of other previous malignancies (including breast cancer)
* history of breast cancer treatment initiated elsewhere
* lack of consent to participate
18 Years
FEMALE
Yes
Sponsors
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AMERICAN SOCIETY FOR CLINICAL PATHOLOGY
UNKNOWN
Hospital Central de Maputo
UNKNOWN
Eduardo Mondlane University
OTHER
M.D. Anderson Cancer Center
OTHER
Renato Cagnacci Neto
OTHER
Responsible Party
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Renato Cagnacci Neto
Principal Investigator
Principal Investigators
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renato cagnacci neto, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
AC Camargo Cancer Center
Locations
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Hospital Central de Maputo
Maputo, Cidade de Maputo, Mozambique
Countries
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References
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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.
Lorenzoni CF, Ferro J, Carrilho C, Colombet M, Parkin DM. Cancer in Mozambique: Results from two population-based cancer registries. Int J Cancer. 2020 Sep 15;147(6):1629-1637. doi: 10.1002/ijc.32953. Epub 2020 Mar 18.
Brandao M, Guisseve A, Bata G, Firmino-Machado J, Alberto M, Ferro J, Garcia C, Zaqueu C, Jamisse A, Lorenzoni C, Piccart-Gebhart M, Leitao D, Come J, Soares O, Gudo-Morais A, Schmitt F, Tulsidas S, Carrilho C, Lunet N. Survival Impact and Cost-Effectiveness of a Multidisciplinary Tumor Board for Breast Cancer in Mozambique, Sub-Saharan Africa. Oncologist. 2021 Jun;26(6):e996-e1008. doi: 10.1002/onco.13643. Epub 2021 Jan 6.
Rosa DD, Bines J, Werutsky G, Barrios CH, Cronemberger E, Queiroz GS, de Lima VCC, Freitas-Junior R, Couto JD, Emerenciano K, Resende H, Crocamo S, Reinert T, Van Eyil B, Neron Y, Dybal V, Lazaretti N, de Cassia Costamilan R, de Andrade DAP, Mathias C, Vacaro GZ, Borges G, Morelle A, Caleffi M, Filho CS, Mano MS, Zaffaroni F, de Jesus RG, Simon SD. The impact of sociodemographic factors and health insurance coverage in the diagnosis and clinicopathological characteristics of breast cancer in Brazil: AMAZONA III study (GBECAM 0115). Breast Cancer Res Treat. 2020 Oct;183(3):749-757. doi: 10.1007/s10549-020-05831-y. Epub 2020 Jul 29.
Simon SD, Bines J, Werutsky G, Nunes JS, Pacheco FC, Segalla JG, Gomes AJS, Adam Van Eyll BMHR, Gimenes DL, Crocamo S, Freitas-Junior R, Lago LD, Queiroz GS, Jobim de Azevedo S, Rosa DD, Delgado G, Borges GS, Veronica do Nascimento Y, Zaffaroni F, Martinez-Mesa J, Barrios CHE. Characteristics and prognosis of stage I-III breast cancer subtypes in Brazil: The AMAZONA retrospective cohort study. Breast. 2019 Apr;44:113-119. doi: 10.1016/j.breast.2019.01.008. Epub 2019 Feb 2.
Tulsidas S, Fontes F, Brandao M, Lunet N, Carrilho C. Oncology in Mozambique: Overview of the Diagnostic, Treatment, and Research Capacity. Cancers (Basel). 2023 Feb 11;15(4):1163. doi: 10.3390/cancers15041163.
Budde H, Williams GA, Scarpetti G, Kroezen M, Maier CB. What are patient navigators and how can they improve integration of care? [Internet]. Copenhagen (Denmark): European Observatory on Health Systems and Policies; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK577640/
Ramirez A, Perez-Stable E, Penedo F, Talavera G, Carrillo JE, Fernandez M, Holden A, Munoz E, San Miguel S, Gallion K. Reducing time-to-treatment in underserved Latinas with breast cancer: the Six Cities Study. Cancer. 2014 Mar 1;120(5):752-60. doi: 10.1002/cncr.28450. Epub 2013 Nov 12.
Raj A, Ko N, Battaglia TA, Chabner BA, Moy B. Patient navigation for underserved patients diagnosed with breast cancer. Oncologist. 2012;17(8):1027-31. doi: 10.1634/theoncologist.2012-0191. Epub 2012 Jul 2.
Cacala SR, Farrow H, Makhanya S, Couch DG, Joffe M, Stopforth L. The Value of Navigators in Breast Cancer Management in a South African Hospital. World J Surg. 2021 May;45(5):1316-1322. doi: 10.1007/s00268-020-05931-2. Epub 2021 Jan 18.
Rodrigues RL, Schneider F, Kalinke LP, Kempfer SS, Backes VMS. Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rev Bras Enferm. 2021 Apr 16;74(2):e20190804. doi: 10.1590/0034-7167-2019-0804. eCollection 2021. English, Portuguese.
Koffi KG, Silue DA, Laurent C, Boidy K, Koui S, Compaci G, Adeba ZH, Kamara I, Botty RP, Bognini AS, Sanogo I, Despas F, Laurent G. AMAFRICA, a patient-navigator program for accompanying lymphoma patients during chemotherapy in Ivory Coast: a prospective randomized study. BMC Cancer. 2019 Dec 23;19(1):1247. doi: 10.1186/s12885-019-6478-3.
Chidebe RCW, Pratt-Chapman ML. Oncology Patient Navigation Training: Results of a Pilot Study in Nigeria. J Cancer Educ. 2022 Aug;37(4):1172-1178. doi: 10.1007/s13187-020-01935-7. Epub 2021 Jan 7.
Henderson V, Tossas-Milligan K, Martinez E, Williams B, Torres P, Mannan N, Green L, Thompson B, Winn R, Watson KS. Implementation of an integrated framework for a breast cancer screening and navigation program for women from underresourced communities. Cancer. 2020 May 15;126 Suppl 10:2481-2493. doi: 10.1002/cncr.32843.
Other Identifiers
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CIBS FM&HCM/054/2023
Identifier Type: -
Identifier Source: org_study_id
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