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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05438511
Enrollment
85
Registered
2022-06-30
Start date
2023-04-13
Completion date
2027-04-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Identify barriers for breast cancer diagnosis in Tanzania.1 yearDepending 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.

Countries

Tanzania, United States

Contacts

CONTACTDiana Ng, MD
NgD2@mskcc.org212-639-7209
CONTACTT. Peter Kingham, MD
kinghamP@mskcc.org212-639-5260
PRINCIPAL_INVESTIGATORDiana Ng, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026