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Mathematisch-Naturwissenschaftliche Fakultät - Jahrgang 2004


Titel Pharmaceutical care for patients with gynaecological malignancies in the outpatient setting
a pilot study
Autor Andrea Liekweg
Publikationsform Dissertation
Abstract Pharmaceutical care in oncology aims at reducing treatment-related toxicity and improve patients’ quality of life. The objective of this pilot study was to develop a specific pharmaceutical care model for breast and ovarian cancer including patient counselling, optimisation of supportive medication and the implementation of a therapeutic algorithm for antiemetic prophylaxis. Additionally, it is the objective of this pilot study to assess the value and feasibility of therapeutic drug monitoring in outpatient settings for patients treated with antineoplastic agents, in particular carboplatin and its contribution to pharmaceutical care.
Patients with breast or ovarian cancer treated with chemotherapy for the first time were included. The feasibility and outcome of this pharmaceutical care model was investigated using a prospective, multi-centred, sequential control group design.
Quality of life (QoL) served as the primary endpoint. Patient satisfaction with the information on cancer treatment and the response to the antiemetic treatment were evaluated as secondary endpoints.
The results regarding the health-related quality of life were difficult to interprete. Looking at the complete treatment period the global health status/QoL decreased in the control group in the median relatively to the baseline by 14% compared to only 6% in the intervention group by (p = 0.563, Mann-Whitney U-test). The quality of life could not be improved but stabilised in comparison to the control group. For certain symptom scales an improvement could be achieved (e.g. pain, constipation) which was not statistically significant.
The global satisfaction with information on cancer treatment was significantly improved throughout the study (CG: median = 3.94, IG: median = 4.41, p = 0.014, Mann-Whitney U-test). Two of the 4 subscales also improved significantly. The patients’ perception of pharmacists much improved throughout the study. Only 15% of the patients in the control group described the pharmacist as one of their most important sources of information compared to 68.4% in the intervention group. This increase was statistically significant (p = 0.001, Mann-Whitney U-test).
The strongest criterion to assess the success of the prevention of nausea and emesis is the complete response (CR) to the antiemetic treatment. Looking at the full treatment period for the intervention group an increase in the number of cycles with CR in emesis could be achieved (p = 0.155). The incidence of nausea could not be improved by the intervention.
The monitoring of carboplatin confirmed results of previous earlier publications on this topic. In the median the achieved AUC differed from the target AUC by 21.7%. The doses necessary to achieve the target AUC would have needed to be in the mean 31.1% (SD 13.65%) higher than the actual dose given.
This pilot study can be rated as an inital contribution to the development of pharmaceutical care models in oncology. Patients with breast and ovarian cancer seem to benefit from pharmaceutical care as demonstrated by improved clinical and subjective outcomes. The pharmaceutical care model was feasible and integrated in the daily routine. It was well accepted by patients and health care providers.
The results of the TDM show a necessity to reconsider the individual dosing strategies for carboplatin in combination with paclitaxel. It proved to be feasible in the outpatient setting and was tolerated by the patients.
In future pharmaceutical care research in oncology further effort should be made to develop improved outcome parameters which are capable of reflecting the impact of pharmaceutical care and allow conclusions on the quality of care. Additionally it should focus on additional aspects such as further patient needs, pharmacoeconomic aspects and standardisation for the integration into disease management programmes.
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© Universitäts- und Landesbibliothek Bonn | Veröffentlicht: 2004