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Breast Neoplasm Malignant PrimaryNAVIMOZNCT06257888

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

An observational study of Breast Neoplasm Malignant Primary, run by Renato Cagnacci Neto at 1 site in Mozambique.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Neoplasm Malignant Primary
What is being tested?
patient navigation
How many people
90 participants
Where
1 siteMozambique
Study dates
1 Mar 2024to 1 May 2025
Phase
Observational
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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mozambique1 site

  • Hospital Central de Maputo

    Maputo, Cidade de Maputo, 010103

Other trials in Mozambique

About this study

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

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.
Read the detailed 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 (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.
Being tested
patient navigation
Keywords
breast cancer, malignant neoplasm of the breast, patient navigation, Carcinoma, Intraductal, Noninfiltrating
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patient navigationOther

    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

Study groups in NCT06257888
Study groupRoleWhat they receive
breast cancer patients under navigationbreast cancer patients, intervention = patient navigation
Receives: Other: patient navigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 12 months

  2. 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)

    Measured: 12 months

  3. 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)

    Measured: 12 months

  4. overall survival

    overall survival (in months) of navigated breast cancer patients

    Measured: 36 months after last patient recruited

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Apr 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257888
Sponsor's protocol ID
CIBS FM&HCM/054/2023
Acronym
NAVIMOZ
Status last verified
Sep 2025
First submitted
6 Feb 2024
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: we will share all collected IPD with any researchers that contact the PI

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 33538338

  • 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.

    PubMed 32142162

  • 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.

    PubMed 33325595

  • 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.

    PubMed 32728860

  • 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.

    PubMed 30738289

  • 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.

    PubMed 36831505

  • 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/

    PubMed 35129934

  • 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.

    PubMed 24222098

  • 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.

    PubMed 22752069

  • 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.

    PubMed 33462702

  • 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.

    PubMed 33886831

  • 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.

    PubMed 31870438

  • 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.

    PubMed 33411251

  • 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.

    PubMed 32348565

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasm Malignant Primary, run by Renato Cagnacci Neto at 1 site in Mozambique.

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 5 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: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mozambique. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time interval between first symptom and first medical consultation (time frame: 12 months). The study lists 4 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 NCT06257888, which also lists 14 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 11 Sep 2025.

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