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

NCT06257888 | Completed

• 1 other identifier: CIBS FM&HCM/054/2023
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasm Malignant Primary

Keywords

breast cancer; malignant neoplasm of the breast; patient navigation; Carcinoma, Intraductal, Noninfiltrating

Outcome Measures

Primary Outcomes (4)

• time interval between first symptom and first medical consultation

  time interval (in days) between first symptom and first medical consultation (either at Maputo Central Hospital or any other medical service)

  12 months

• time interval between first medical consultation and cancer diagnosis

  time interval (in days) between first medical consultation (at Maputo Central Hospital) and cancer diagnosis (by any type of biopsy performed at Maputo Central Hospital)

  12 months

• time interval between cancer diagnosis and first treatment

  time interval (in days) between cancer diagnosis (by any type of biopsy performed at Maputo Central Hospital) and first treatment (surgery or neoadjuvant chemotherapy at Maputo Central Hospital)

  12 months

• overall survival

  overall survival (in months) of navigated breast cancer patients

  36 months after last patient recruited

Study Arms (1)

breast cancer patients under navigation

breast cancer patients, intervention = patient navigation

Other: patient navigation

Interventions

patient navigation OTHER

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

breast cancer patients under navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

we will recruit all female primary breast cancer patients (invasive or in situ) admitted for treatment at HCM during a 12 month period

You may qualify if:

• female
• years and older
• will undergo breast cancer treatment at HCM
• consent to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Renato Cagnacci Neto: lead
• AMERICAN SOCIETY FOR CLINICAL PATHOLOGY: collaborator
• Hospital Central de Maputo: collaborator
• Eduardo Mondlane University: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

Hospital Central de Maputo

Maputo, Cidade de Maputo, 010103, Mozambique

Location

Related Publications (14)

• 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.

  PMID: 33538338 BACKGROUND

• 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.

  PMID: 32142162 BACKGROUND

• 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.

  PMID: 33325595 BACKGROUND

• 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.

  PMID: 32728860 BACKGROUND

• 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.

  PMID: 30738289 BACKGROUND

• 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.

  PMID: 36831505 BACKGROUND

• 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/

  PMID: 35129934 BACKGROUND

• 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.

  PMID: 24222098 BACKGROUND

• 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.

  PMID: 22752069 BACKGROUND

• 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.

  PMID: 33462702 BACKGROUND

• 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.

  PMID: 33886831 BACKGROUND

• 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.

  PMID: 31870438 BACKGROUND

• 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.

  PMID: 33411251 BACKGROUND

• 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.

  PMID: 32348565 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• renato cagnacci neto, MD, MSc

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: available after publication for one year

Locations

MO (1)