Clinical trial NCT05438511: A Formative Evaluation For Improving Breast Cancer Hormone Receptor Testing in Tanzania
Official title: A Formative Evaluation For Improving Breast Cancer Hormone Receptor Testing in Tanzania
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer hormone receptor testing
breast cancer testing
GeneXpert STRAT4
Memorial Sloan Kettering Cancer Center
21-480
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Purposeful sampling will be used 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Identify barriers for breast cancer diagnosis in Tanzania.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Dar Es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Diana Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: