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the two cancer registries in the country and the cancer prevalence of the main cancer types documented.
Figure 3. 1: Geographic coverage of Uganda cancer registries and cancer prevalence
“UCI is the only specialized national referral oncology center in Uganda. It located in the central region of the country in Kampala capital city. The center receives about 1,000 new cancer patients referred for chemotherapy annually. Currently, it has a bed capacity of about 100 beds with 8 specialist medical oncologists, 2 pharmacists, 10 medical officers and 50 trained oncology nurses (Kibudde et al., 2019).” “UCI offers all cancer services including: prevention and early detection;
diagnosis; treatment; and palliation. Cancer care at UCI is mainly offered for free including; cancer
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screening; diagnosis; oncologist consultations; surgery; and all cancer medicines available in the UCI pharmacy. Due to recurrent stock-outs, patients may have to buy medicines that are not available in the pharmacy, and due to the limited number of surgical-oncologists in the country, most patients seek specialized cancer surgery from private practices. In addition, patients cost- share for radiotherapy services by paying a standard fee of about $85USD before accessing all the prescribed radiation cycles (Nakaganda et al., 2021).” About 60% of patients attending UCI receive anthracycline therapy (Kibudde et al., 2019).”
Uganda Heart Institute is a specialized provider of cardiovascular services and the only public referral facility for heart disease in Uganda. The institute handles over 20,000 patients annually, including over 95% of the adult patients and 58% of the cases among children in Uganda.
3.3 Inclusion and exclusion criteria Inclusion criteria:
1. Age ≥ 18 years
2. Newly diagnosed cancer patients
3. Planed for anthracycline based chemotherapy Exclusion criteria:
1. Impaired LV systolic function (LVEF < 50%) at the baseline# 2. Poor quality 2D image##
3. Left bundle branch block (LBBB) electrocardiogram (ECG) pattern##
4. Anthracycline therapy was changed or canceled
#: Patients with impaired LV function are not eligible for anthracycline chemotherapy, therefore were excluded.
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##: Patients with poor quality 2D image and LBBB ECG pattern would make the correct strain analysis impossible, therefore were excluded.
3.4 Patients recruitment and follow up
Between November 2018 and April 2021, adults (18 years and above) cancer patients, who were planned for anthracycline based chemo therapy, were recruited at the baseline (pre-chemo therapy) consecutively and being followed up until 6 months after ending of anthracycline therapy. Data on patient’s demographics, cancer profile, past medical history were collected at the baseline. Patients’
symptoms, physical examinations, ECG, ECHO and laboratory data were collected at baseline, and two follow up visits (end of anthracycline therapy and 6 months after ending anthracycline therapy) (Table 3.1).
A total of 383 patients were screened over a period of 15 months. Two (2) patients were excluded due to LV systolic dysfunction, 24 patients were excluded due to poor quality 2D images and 1 patient was excluded due to LBBB ECG pattern. There were 113 patients never got chemo therapy due to various reasons and 33 patients loss to follow up. In total, 207 patients enrolled at the baseline, were able to complete anthracycline therapy and came back for the 2nd visit at the end of the anthracycline therapy. Among them, 145 patients came back for the 3rd visit after 6months, 27 patients dead, 16 patients were last known alive and 19 patients were considered as lost to follow up. (Figure 3.2)
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Figure 3. 2: Patients’ flow chart for the main study 3.5 Clinical intake protocol
The following data was collected from all enrolled subjects.
Patient demographics: age, gender, tribe, district
Cancer profile: Cancer diagnosis and stage, type of anthracycline and accumulated dosage*, other medications*
Past medical and social history: hypertension, diabetes mellitus, coronary heart disease, renal disease, HIV, smoking, alcohol intake, any other chronic illnesses
Family history of heart disease or cancer
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Current clinical presentation*: symptoms of heart failure, NYHA class, heart failure stage
Physical examination*: weight, height, temperature, blood pressure**, heart rate, SaO2, signs of heart failure (raised JVP, edema, rails…)
The following investigative tests were performed:
12-leads ECG*
Comprehensive ECHO*: using 2D, M-mode, Doppler, tissue Doppler, STE image to assess cardiac structure, function and hemodynamics.
Blood test*: CBC, LFTs, RFTs, Troponin I, Lipoprotein subfractions analysis***.
*: Collected at each visit
**: Patient’s left arm blood pressure was taken at sitting position, using “Omron” digital blood pressure machine, after resting for 5 minutes.
***: This test was done on selected patients for sub study (Refer to chapter 7)
Data Baseline
Completion of anthracycline therapy
6 months after completion of
anthracycline therapy
Demographics X
Cancer data X X
Medical & social history X
Symptoms & physical examinations X X X
ECG X X X
ECHO X X X
Lab test X X X
Table 3. 1: Data collection and patients follow-up
40 3.6 Informatics and Statistical Considerations 3.6.1 Study Information Management
Study data was entered through specialized online study forms into a central database in RED Cap.
RED Cap is a widely used research information system that provides for form-based entry of study data with quality assurance tools to check the validity and consistency of results.
3.6.2 Data management and analysis
Raw data was collected on the predesigned case report forms and later was entered into a study specific Redcap database for storage and further statistical analysis. We analyzed the data using Stata software (version 14). All continuous variables were expressed as a mean ± standard deviation (SD) and categorical variables as a percentage. Statistical analysis methods to achieve the specific research objectives are presented with details in the following chapters.
3.7 Ethical consideration
Ethical approvals were obtained from School of Medicine Ethics and Research Committee, College of Health Sciences Makerere University (REC REF 2018-081), Uganda National Council of Science and Technology (HS220ES) and Faculty of Health Sciences Human Research Ethics Committee, University of Cape Town (HREC 054/2020sa).
All participants were provided with a written copy of the consent form. Any and all questions that participants had regarding the research were addressed prior to signing of the consent form.
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