A Prospective Cohort With Patient Navigation as an Intervention for Breast Cancer Patients

Breast Neoplasm Malignant Primary Clinical Trial

— NAVIMOZ  

Official title:

The Journey of Women With Breast Cancer in Mozambique: What is the Best Path? A Prospective Cohort With Patient Navigation as an Intervention to Reduce Treatment Disparities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06257888
• Other study ID #: CIBS FM&HCM/054/2023
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: AC Camargo Cancer Center
• Contact: renato cagnacci neto, MD, MSc
• Phone: +55 1121895000
• Email: renato.neto[@]accamargo.org.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this observational study is to introduce a patient navigation system within the breast cancer unit at Hospital Central de Maputo (MOZ) and gather data to assess the efficacy of patient navigation in enhancing oncological outcomes among this patient cohort. The primary inquiries it seeks to address are as follows:

• 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.

Description:

-General Objective: To implement an oncological navigation platform for breast cancer patients receiving treatment at Maputo Central Hospital (HCM) over a proposed period of 12 months after project approval by the local IRB.

-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.

• Collect diverse epidemiological data from navigated patients during the proposed study period.

• Compare the time interval (in days) between admission to HCM and initiation of cancer treatment (surgery or systemic treatment) among patients in this cohort versus patients already treated in the service with available data in the National Cancer Registry (NCR).

• Compare overall survival between patients in this cohort and a locally published historical cohort from 2020.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female

• 18 years and older

• will undergo breast cancer treatment at HCM

• consent to participate

Exclusion Criteria:

• male

• 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

Related Conditions & MeSH terms

• Breast Neoplasm Malignant Primary
• Breast Neoplasms
• Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Renato Cagnacci Neto	AMERICAN SOCIETY FOR CLINICAL PATHOLOGY, Eduardo Mondlane University, Hospital Central de Maputo, M.D. Anderson Cancer Center

References & Publications (14)

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. — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time interval between admission and treatment	time interval (in days) between admission to HCM and initiation of cancer treatment (surgery or systemic treatment)	12 months
Primary	overall survival	overall survival (in months) of navigated breast cancer patients	12 months from admission