Effectiveness of Pharmacist Intervention on Capecitabine Relative Dose Intensity, Adherence, Knowledge & Safety Among Cancer Patients in Malaysia.
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Relative Dose Intensity - Mid Treatment
研究概览
简要总结
Over the past decade, oral administration of chemotherapy has significantly increased and is anticipated to continue to grow. Despite the conveniences, these oral regimens can be complex and pose challenge to patient adherence. Further safety concerns are warranted due to insufficient patient education, general perception of reduced toxicity with oral treatment, improper prescribing practice, and the lack of monitoring of observable adverse effects.
Therefore, effective medication counselling and patient education is vital to empower patients and their caregivers to increase adherence and safely managed medication to achieve optimal treatment outcome.
This study aims to evaluate the effectiveness of pharmacist intervention with structured oral chemotherapy education and patient monitoring on capecitabine treatment effectiveness (Relative Dose Intensity (RDI), Adherence and Persistence), safety outcomes (Adverse Event, Drug Related Problem and Health service utilization) and chemotherapy knowledge and self-efficiency among cancer patient care in Penang, a northern state oncology referral centre.
There are numerous published studies of pharmaceutical care implementations focusing mainly on in-patient setting and currently evolving in ambulatory cancer patients especially in western countries compared to Asian region. However systematic reviews show major gap still exist with paucity of scientific evidence on the effectiveness of therapeutic educational interventions for improving patient safety and adherence to oral chemotherapy mainly due to study design and method that are unable to strongly prove the outcome.
Hence highlighting the novelty and significance for this research using randomized controlled design, standardized & validated tools for multimodal pharmacist intervention, long-term clinical outcome such as RDI with longitudinal assessment till treatment completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be screened according to the inclusion criteria below;
- •Adult patients (≥ 18 years old)
- •Ambulatory patients (daycare or out-patient oncology department clinic)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 2 or below,
- •Diagnosis of Colorectal, Breast, Stomach cancer
- •Newly started on oral Capecitabine (Xeloda) either as a single agent or in combination with other intravenous chemotherapy
- •Adjuvant or metastatic treatment intent
- •Patients who have given written consent to participate in the study.
排除标准
- •The following patients will be excluded from the study:
- •Patients who are ongoing in other clinical trial,
- •Patients with dementia, cognitive disability, mental retardation, Alzheimer's or Parkinson's
- •Patients on concurrent radiotherapy regime with capecitabine.
- •Patients who are unable to respond to questions or could not speak and understand Malay, English or Chinese language
- •Patients who are unable to complete the questionnaires with minimal assistance from researchers
结局指标
主要结局
Relative Dose Intensity - Mid Treatment
时间窗: 3 months
RDI will be assessed at the end of Cycle 4 (each cycle is 21 days). Relative dose intensity (RDI), defined as the total dose administered divided by the total dose specified by the corresponding standard regimen.
Daily Adherence
时间窗: 6 months
Daily Adherence will be assessed at the end of Cycle 8 (each cycle is 21 days). The daily adherence level determined by the pill count, patient diary record at each visit, which considered both the correct administration of capecitabine twice daily for 14 days and correct non-administration of any dose on rest days to be determined as adherent throughout the 21 day cycle.
Relative Dose Intensity - End of Treatment
时间窗: 6 months
RDI will be assessed at the end of Cycle 8 (each cycle is 21 days). Relative dose intensity (RDI), defined as the total dose administered divided by the total dose specified by the corresponding standard regimen.
次要结局
- Medication Adherence Report Scale (MARS-5) C4(3 months)
- Persistence to Treatment(6 months)
- Medication Adherence Report Scale (MARS-5) C1(3 weeks)
- Capecitabine Medication Taking Behavior Questionnaire C1(3 weeks)
- Capecitabine Medication Taking Behavior Questionnaire C8(6 months)
- Change in Chemotherapy Knowledge & Self-Efficiency C4(3 months)
- Change in Adverse Drug Events (ADE) - Toxicity Score(6 months)
- Drug Related Problem (DRP) and Pharmacist Intervention(6 month)
- Medication Adherence Report Scale (MARS-5) C8(6 months)
- Capecitabine Medication Taking Behavior Questionnaire C4(3 months)
- Change in Chemotherapy Knowledge & Self-Efficiency C1(3 weeks)
- Change in Chemotherapy Knowledge & Self-Efficiency C8(6 months)
- Health service utilization(6 month)
研究者
Tajunisah Mohamed Eusoff
Principle Investigator
Ministry of Health, Malaysia