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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438511
• Other study ID #: 21-480
• Status: Recruiting
• Start date: April 13, 2023
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Diana Ng, MD
• Phone: 212-639-7209
• Email: NgD2[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Participant Inclusion Criteria:

• 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

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: none

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar Es Salaam
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Countries where clinical trial is conducted

United States,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center