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

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: Breast Cancer
• Intervention / Treatment: Behavioral: Focus group; Behavioral: Organizational Readiness for Implementing Change

• Study Type: Observational
• Enrollment (Estimated): 85

Contacts and Locations

• Study Contact: Name: Diana Ng, MD; Phone Number: 212-639-7209; Email: NgD2@mskcc.org
• Study Contact Backup: Name: T. Peter Kingham, MD; Phone Number: 212-639-5260; Email: kinghamP@mskcc.org

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania
    • Recruiting
    • Muhimbili University of Health and Allied Sciences
    • Contact: Edda Vuhahula, DDS PhD; Email: evuhahula@yahoo.co.uk
• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All protocol activities)
      • Contact: Diana Ng, MD; Phone Number: 212-639-7209; Email: NgD2@mskcc.org

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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.	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

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

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

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): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; breast cancer hormone receptor testing; breast cancer testing; GeneXpert STRAT4; 21-480
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Focus Groups
• 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