Breast CancerNCT05438511
A Formative Evaluation For Improving Breast Cancer Hormone Receptor Testing in Tanzania
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Focus group and Organizational Readiness for Implementing Change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 85 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Apr 2023to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18 years and above
- Permanent residents or citizens of Tanzania
- Received breast cancer diagnosis
Who cannot join
- Participants less than 18 years of age
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Diana Ng, MD, 212-639-7209, NgD2@mskcc.org
Tanzania1 site, 1 recruiting
- Recruiting
Muhimbili University of Health and Allied Sciences
Dar es Salaam
Edda Vuhahula, DDS PhD, evuhahula@yahoo.co.uk
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- Focus group, Organizational Readiness for Implementing Change
- Keywords
- breast cancer hormone receptor testing, breast cancer testing, GeneXpert STRAT4, Memorial Sloan Kettering Cancer Center, 21-480
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupBehavioural
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.
Organizational Readiness for Implementing ChangeBehavioural
Also called ORIC tool
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Focus group; Behavioral: Organizational Readiness for Implementing Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start13 Apr 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Ng, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438511
- Sponsor's protocol ID
- 21-480
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Formative Evaluation For Improving Breast Cancer Hormone Receptor Testing in Tanzania
- ClinicalTrials.gov ID
- NCT05438511
- Acronym / sponsor ID
- 21-480
- Conditions
- Breast Cancer
- Keywords
- breast cancer hormone receptor testing, breast cancer testing, GeneXpert STRAT4, Memorial Sloan Kettering Cancer Center, 21-480
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants of focus groups | – | Behavioral: Focus group, Behavioral: Organizational Readiness for Implementing ChangeBreast cancer survivor, patient advocate or key healthcare personnel including hospital and laboratory leaders, pathologists, laboratory scientists and technicians, oncologists, nurses, and surgeons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 years and above
- Permanent residents or citizens of Tanzania
- Received breast cancer diagnosis
Key exclusion criteria (1 listed)
- Participants less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupA 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. | Behavioural | Participants of focus groups |
| Organizational Readiness for Implementing ChangeAlso: ORIC toolmeasures 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. | Behavioural | Participants of focus groups |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana Ng, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in 2 countries.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Tanzania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Ng, MD (212-639-7209, NgD2@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify barriers for breast cancer diagnosis in Tanzania. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.