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

August 4, 2025 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Tanzania
      • Dar Es Salaam, Tanzania
        • Recruiting
        • Muhimbili University of Health and Allied Sciences
        • Contact:
  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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 for chart review:

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

Exclusion Criteria for chart review:

  • Participants less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Behavioral: Organizational 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.
Other Names:
  • ORIC tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify barriers for breast cancer diagnosis in Tanzania.
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Diana Ng, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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