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RecruitingNCT05438511Updated Jun 29, 2026

A Formative Evaluation For Improving Breast Cancer Hormone Receptor Testing in Tanzania

An observational study in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
85
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to learn more about the challenges with breast cancer diagnosis in Tanzania and the support available to improve this process.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer hormone receptor testing
  • breast cancer testing
  • GeneXpert STRAT4
  • Memorial Sloan Kettering Cancer Center
  • 21-480
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 85 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Aim 1: We will use purposeful sampling to select the study participants of 70 participants. The representative participants from the following groups will be identified: hospital and laboratory leadership, pathologists, laboratory scientists and technicians, oncologists, surgeons, nurses, and patient survivors/patient advocates. With the exception of patient survivors and patient advocates, each focus group discussion will have only 1-2 representatives from a particular stakeholder group. Stakeholders will be adults, must have already completed their clinical or laboratory training, and have at least one year of clinical experience in breast cancer care. Patient survivors and patient advocates will be interviewed separately, and must be adults and with a prior diagnosis of breast cancer.

Aim 2: Participants that were recruited in Aim 1 will be offered the opportunity to participate in follow up interviews to brainstorm implementation strategies.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Participant Inclusion Criteria for interviews and focus group discussions (Aims 1 and 2):

  • Breast cancer survivor, patient advocate or key healthcare personnel

    • Key healthcare personnel are defined as hospital and laboratory leaders, pathologists, laboratory scientists and technicians, oncologists, nurses, and surgeons, with:
    • >12 months of employment at the affiliated institution
    • Administrative or clinical involvement in the delivery of breast cancer care services.
  • Age 18 years and above
  • Permanent residents or citizens of Tanzania
  • Participant and/or LAR willing and able to consent
  • Fluent in Swahili and/or English by self-report

Participant Exclusion Criteria:

  • Key stakeholder not residing at their particular institutions during data collection will be excluded.

Eligibility criteria for Chart Reviews (Aim 1)

Inclusion criteria

Inclusion Criteria for chart review:

  • Age 18 years and above
  • Permanent residents or citizens of Tanzania
  • Received breast cancer diagnosis

Exclusion criteria

Exclusion Criteria for chart review:

  • Participants less than 18 years of age
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
85 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants of focus groups

    Breast cancer survivor, patient advocate or key healthcare personnel including hospital and laboratory leaders, pathologists, laboratory scientists and technicians, oncologists, nurses, and surgeons

    Behavioral: Focus group · Behavioral: Organizational Readiness for Implementing Change

Interventions

  • BehavioralFocus group

    A semi-structured focus group discussion guide will be developed with question probes that cover 1) contextual factors, 2) barriers to implementation, and 3) facilitators to implementation, with secondary probing questions.

  • BehavioralOrganizational Readiness for Implementing Change

    measures the extent to which organizational members are prepared to implement organizational change. The ORIC tool asks participants to rate their level of agreement with 12 statements pertaining to organizational readiness for change (change commitment and change efficacy) on a 5-point Likert Scale.

    Also known as: ORIC tool

06

What researchers measure

Primary outcomes

  1. Identify barriers for breast cancer diagnosis in Tanzania.

    Depending on results of this initial evaluation, either additional data will be collected, or if successful, will use the data to begin identifying context-specific implementation strategies using the 'Implementation Mapping' framework1 . In a future protocol, these data will then be used to develop a strategy for an intervention that addresses urgent evidence-to-practice gaps in breast cancer diagnosis in Tanzania, and has the potential to help patients with breast cancer in sub-Saharan Africa (SSA) in the future. The collection of this key information will assist us and our collaborators to generate background data that can be used to develop and/or complement future clinical trials.

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05438511
Responsible party
Sponsor
First posted
Jun 30, 2022
Start date
Apr 13, 2023
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Jun 29, 2026

Study contacts

Diana Ng, MD
Contact
NgD2@mskcc.org
212-639-7209
T. Peter Kingham, MD
Contact
kinghamP@mskcc.org
212-639-5260
Diana Ng, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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