Clinical trial NCT04175899: Effectiveness of Pharmacist Intervention on Capecitabine Relative Dose Intensity, Adherence, Knowledge & Safety Among Cancer Patients in Malaysia
Official title: Effectiveness of Pharmacist Intervention on Capecitabine Relative Dose Intensity, Adherence, Knowledge & Safety Among Cancer Patients in Malaysia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor, Adult
Keywords: Capecitabine
Pharmacist Intervention
Adherence
Relative Dose Intensity
Medication Knowledge
Safety
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
Collaborators: name: Universiti Sains Malaysia
First posted: 2019-11-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Patients will be screened according to the inclusion criteria below;

1. Adult patients (≥ 18 years old)
2. Ambulatory patients (daycare or out-patient oncology department clinic)
3. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or below,
4. Diagnosis of Colorectal, Breast, Stomach cancer
5. Newly started on oral Capecitabine (Xeloda) either as a single agent or in combination with other intravenous chemotherapy
6. Adjuvant or metastatic treatment intent
7. Patients who have given written consent to participate in the study.

Exclusion Criteria:

The following patients will be excluded from the study:

1. Patients who are ongoing in other clinical trial,
2. Patients with dementia, cognitive disability, mental retardation, Alzheimer's or Parkinson's
3. Patients on concurrent radiotherapy regime with capecitabine.
4. Patients who are unable to respond to questions or could not speak and understand Malay, English or Chinese language
5. Patients who are unable to complete the questionnaires with minimal assistance from researchers

Primary outcomes:
measure: Relative Dose Intensity - End of Treatment
timeFrame: 6 months
measure: Relative Dose Intensity - Mid Treatment
timeFrame: 3 months
measure: Daily Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Persistence to Treatment
timeFrame: 6 months
measure: Medication Adherence Report Scale (MARS-5) C1
timeFrame: 3 weeks
measure: Medication Adherence Report Scale (MARS-5) C4
timeFrame: 3 months
measure: Medication Adherence Report Scale (MARS-5) C8
timeFrame: 6 months
measure: Capecitabine Medication Taking Behavior Questionnaire C1
timeFrame: 3 weeks
measure: Capecitabine Medication Taking Behavior Questionnaire C4
timeFrame: 3 months
measure: Capecitabine Medication Taking Behavior Questionnaire C8
timeFrame: 6 months
measure: Change in Chemotherapy Knowledge & Self-Efficiency C1
timeFrame: 3 weeks
measure: Change in Chemotherapy Knowledge & Self-Efficiency C4
timeFrame: 3 months
measure: Change in Chemotherapy Knowledge & Self-Efficiency C8
timeFrame: 6 months
measure: Change in Adverse Drug Events (ADE) - Toxicity Score
timeFrame: 6 months
measure: Drug Related Problem (DRP) and Pharmacist Intervention
timeFrame: 6 month
measure: Health service utilization
timeFrame: 6 month
Other outcomes:
Locations:
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
Study officials:
affiliation: Universiti Sains Malaysia
name: Balamurugan Tangiisuran, PhD
role: STUDY_DIRECTOR
References: