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NCT Number: NCT05438511

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus Group

Behavioral

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

Behavioral

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

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Ng, MD

CONTACT

[email protected]

212-639-7209

T. Peter Kingham, MD

CONTACT

[email protected]

212-639-5260

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Jun 30, 2022
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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