Delayed breast cancer presentation, diagnosis, and treatment in Kenya.

PURPOSE: In this mixed-methods study, we evaluated the factors that contribute to delayed breast cancer (BC) diagnosis and treatment at a Kenyan hospital. METHODS: Individuals with a diagnosis of BC, either as a referral or index patient, were recruited to participate in this study through convenience sampling. Data were collected on sociodemographics, health history, and cancer history, diagnosis, and treatment of patients at Kenyatta National Hospital (KNH). For the quantitative analyses, the relationship between sociodemographic and health history factors with stage at diagnosis, number of visits before diagnosis, time to diagnosis, and time to initial intervention, stratified by time to onset of symptoms, were examined using regression analyses. For the qualitative analysis, in-depth interviews of every fifth patient were completed to assess reasons for delayed diagnosis and treatment. RESULTS: The final analytic sample comprised of 378 female BC patients with an average age of 50. These females were generally of lower SES: 49.2% attained no or only primary-level education, 57.4% were unemployed, and the majority (74.6%) had a monthly household income of < 5000 Kenyan shillings (equivalent to ~ $41 USD). The median time from BC symptom onset to presentation at KNH was 13 (IQR = 3-36) weeks, from presentation to diagnosis was 17.5 (IQR = 7-36.5) weeks, and from diagnosis to receipt of the initial intervention was 6 (IQR = 3-13) weeks. Female BC patients who were never/unmarried, less educated, less affluent, users of hormonal contraception, and had ≥ 3 children were more likely to experience diagnosis and treatment delays. Qualitative data showed that financial constraints, lack of patient BC awareness, and healthcare practitioner misdiagnosis and/or strikes delayed patient diagnosis and treatment. CONCLUSIONS: BC patients experience long healthcare system delays before diagnosis and treatment. Educating communities and providers about BC and expediting referrals may minimize such delays and subsequently BC mortality rates in Kenya.

Randomized control trial of advanced cancer patients at a private hospital in Kenya and the impact of dignity therapy on quality of life.

BACKGROUND: Palliative care is a modality of treatment that addresses physical, psychological and spiritual symptoms. Dignity therapy, a form of psychotherapy, was developed by Professor Harvey Chochinov, MD in 2005.The aim of the study was to assess the effect of one session of dignity therapy on quality of life in advanced cancer patients. METHODS: This was a randomized control trial of 144 patients (72 in each arm) randomized into group 1 (intervention arm) and group 2 (control arm). Baseline ESAS scores were determined in both arms following which group 1 received Dignity therapy while Group 2 received usual care only. Data collected was presented as printed (Legacy) documents to group 1 participants. These documents were a summary of previous discussions held. Post intervention ESAS scores were obtained in both groups after 6 weeks. Analysis was based on the intention to treat principle and descriptive statistics computed. The main outcome was symptom distress scores on the ESAS (summated out of 100 and symptom specific scores out of 10). The student T-test was used to test for difference in ESAS scores at follow up and graphs were computed for common cancers and comorbidities. RESULTS: Of the 144 (72 patients in each arm) patients randomized, 70%were female while 30% were male with a mean age of 50 years. At 6 weeks, 11 patients were lost to follow up, seven died and 126 completed the study. The commonly encountered cancers were gastrointestinal cancers (43%, p = 0.29), breast cancer (27.27% p = 0.71) and gynaecologic cancers (23% p = 0.35). Majority of the patients i.e. 64.3% had no comorbidities. The primary analysis results showed higher scores for the DT group (change in mean = 1.57) compared to the UC group (change in mean = - 0.74) yielding a non-statistically significant difference in change scores of 1.44 (p = 0.670; 95% CI - 5.20 to 8.06). After adjusting for baseline scores, the mean (summated) symptom distress score was not significant (GLM p = 0.78). Dignity therapy group showed a trend towards statistical improvement in anxiety (p = 0.059). The largest effects seen were in improvement of appetite, lower anxiety and improved wellbeing (Cohen effect size 0.3, 0.5 and 0.31 respectively). CONCLUSION: Dignity therapy showed no statistical improvement in overall quality of life. Symptom improvement was seen in anxiety and this was a trend towards statistical significance (p = 0.059). TRIAL REGISTRATION: Trial registration number PACTR201604001447244 retrospectively registered with Pan African Clinical trials on 28th January 2016.

Geographical variation in the response of visceral leishmaniasis to paromomycin in East Africa: a multicentre, open-label, randomized trial.

BACKGROUND: Visceral leishmaniasis (VL) is a major health problem in developing countries. The untreated disease is fatal, available treatment is expensive and often toxic, and drug resistance is increasing. Improved treatment options are needed. Paromomycin was shown to be an efficacious first-line treatment with low toxicity in India. METHODS: This was a 3-arm multicentre, open-label, randomized, controlled clinical trial to compare three treatment regimens for VL in East Africa: paromomycin sulphate (PM) at 15 mg/kg/day for 21 days versus sodium stibogluconate (SSG) at 20 mg/kg/day for 30 days; and the combination of both dose regimens for 17 days. The primary efficacy endpoint was cure based on parasite-free tissue aspirates taken 6 months after treatment. FINDINGS: Overall, 135 patients per arm were enrolled at five centres in Sudan (2 sites), Kenya (1) and Ethiopia (2), when the PM arm had to be discontinued due to poor efficacy. The trial has continued with the higher dose of PM as well as the combination of PM and SSG arms. These results will be reported later. Baseline patient characteristics were similar among treatment arms. The overall cure with PM was significantly inferior to that with SSG (63.8% versus 92.2%; difference 28.5%, 95%CI 18.8% to 38.8%, p<0.001). The efficacy of PM varied among centres and was significantly lower in Sudan (14.3% and 46.7%) than in Kenya (80.0%) and Ethiopia (75.0% and 96.6%). No major safety issues with PM were identified. CONCLUSION: The efficacy of PM at 15 mg/kg/day for 21 days was inadequate, particularly in Sudan. The efficacy of higher doses and the combination treatment warrant further studies.