Study Objectives

• Aim 1 (Primary): To evaluate if the establishment of a multidisciplinary breast cancer clinic can lead to improved timely quality care. Primary endpoint associated with this aim is shorter time to treatment initiation (time from diagnosis to initiation of cancer treatment).
• Aim 2: To assess characteristics of breast cancer patients in Botswana, including key risk factors and pathology.
• Aim 3. To pilot improvement of documentation of breast cancer care, leveraging electronic health information system

Study Design

• Aim 1: An observational cohort study of newly diagnosed breast cancer patients presenting to Princess Marina Hospital’s multidisciplinary breast clinic, compared with historical control patients previously enrolled in the Botswana Prospective Cancer Cohort Study.
• Aim 2: A retrospective review study of patients included in Aim 1, describing patient characteristics and present breast cancer risk factors.
• Aim 3: A pilot implementation study, which will involve a series of cross-sectional reviews of acquisition of data in key data fields in IPMS electronic health information system. 

Study Population

The study involved male and female adults (including pregnant women) with breast cancer, who have been managed at Princess Marina and Nyangabgwe Referral Hospitals.  Childhood breast cancers are rare, and thus children 18 years and younger will be excluded. Involuntarily incarcerated individuals will not be enrolled.

Study Sample Size

Aim 1 (Primary): To evaluate if the establishment of a multidisciplinary breast cancer clinic can lead to improved timeliness and quality of care.

From historical data available from breast cancer patients enrolled in the BPCC, the mean time from initial clinic visit to breast cancer treatment initiation was 305 days (or 10.0 months).  An initial sample size of 256 ‘events’ (i.e. 128 new multidisciplinary clinic patients + 128 historical controls) has been estimated. This was calculated to have a power of 90% and type I error rate of 0.05 to determine if there is a 25% reduction in the primary outcome of time of initial clinic visit to treatment initiation, using the hypothesis test comparing two independent means. Assuming that 25% of eligible patients may be lost to follow-up, we have adjusted the sample size to 320 patients (160 new multidisciplinary clinic patients + 160 historical controls). 

Aim 2: To assess characteristics of breast cancer patients in Botswana, including key risk factors and pathology

As this is a descriptive and implementation study, no primary endpoints were defined, and sample size was not calculated to have adequate power to answer specific questions. The same patients analyzed for Aim 1 will be included in the analysis of Aim 2. We will conduct simple descriptive analyses to describe proportions of patients with particular characteristics.  

Aim 3. To pilot improvement of documentation of cancer care, using breast cancer as a case example and leveraging electronic health information system.

As this is an exploratory implementation exercise, sample size was not calculated to have adequate power to answer specific questions. The same patients analyzed for Aim 1 will be included in the analysis of Aim 3. We will conduct simple descriptive analyses to describe proportions of patients for which key data elements have been populated in IPMS and trends over time. 

Study Duration: 48 months.

Sponsor: Federal Share K12 Funding.