A Formative Evaluation For Improving Breast Cancer Hormone Receptor Testing in Tanzania
1 other identifier
observational
85
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedAugust 5, 2025
August 1, 2025
3 years
June 17, 2022
August 4, 2025
Conditions
Keywords
Outcome Measures
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.
1 year
Study Arms (1)
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
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Key stakeholder not residing at their particular institutions during data collection will be excluded.
- Eligibility criteria for Chart Reviews (Aim 1)
- Age 18 years and above
- Permanent residents or citizens of Tanzania
- Received breast cancer diagnosis
- Participants less than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana Ng, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2022
First Posted
June 30, 2022
Study Start
April 13, 2023
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
August 5, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
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.