Effectiveness of Pharmacist Intervention on Capecitabine Relative Dose Intensity, Adherence, Knowledge & Safety Among Cancer Patients in Malaysia

NCT ID: NCT04175899

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2021-11-30

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.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

POCCP (Pharmacist-led Oral Chemo Care Program)

Intervention Group :

Subjects undergo structured intensified pharmaceutical care program (POCCP) led by oncology experienced pharmacist (run alongside oncologist patient review at the clinic or daycare) in addition to Current Standard Best Care (SBC)

Group Type: EXPERIMENTAL

Pharmacist-led Oral Chemo Care Program (POCCP)

Intervention Type: OTHER

Structured intensified pharmaceutical care program for patients ongoing oral chemotherapy treatment.

Led by oncology experienced clinical pharmacist and run alongside oncologist patient review at the clinic or daycare.

It utilizes structured educational material (for patients) and monitoring guideline or checklists (for pharmacists) during provision of service at each clinic visit such as patient education, pre-treatment review, medication reconciliation, prescription screening (dose, regime, supportive meds), adherence, adverse drug event monitoring and treatment recommendations on basis of agreed protocols.

Pharmacist scheduled additional review within 1-week interval of start of oral chemotherapy at clinic or via phone call (according to patient's preference) will also be conducted to review patients taking their oral medications at home, assess adherence and symptom experienced to provide individualized recommendations or support to patients.

SBC (Current Standard Best Care)

Control Group :

Subjects undergo usual procedure which is Current Standard Best Care (SBC) for oral chemotherapy treatment which includes pre-chemotherapy review by doctor and prescribing of chemotherapy and supportive medications according to patient's chemotherapy protocol at each visit. Subsequently the patients will collect their prescribed oral medications at the ambulatory pharmacy counter according to the standard procedure of medication dispensing which includes prescription screening, medication filling, double checking, dispensing and counselling at the pharmacy counter as per usual practice of pharmaceutical care of patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharmacist-led Oral Chemo Care Program (POCCP)

Structured intensified pharmaceutical care program for patients ongoing oral chemotherapy treatment.

Led by oncology experienced clinical pharmacist and run alongside oncologist patient review at the clinic or daycare.

It utilizes structured educational material (for patients) and monitoring guideline or checklists (for pharmacists) during provision of service at each clinic visit such as patient education, pre-treatment review, medication reconciliation, prescription screening (dose, regime, supportive meds), adherence, adverse drug event monitoring and treatment recommendations on basis of agreed protocols.

Pharmacist scheduled additional review within 1-week interval of start of oral chemotherapy at clinic or via phone call (according to patient's preference) will also be conducted to review patients taking their oral medications at home, assess adherence and symptom experienced to provide individualized recommendations or support to patients.

Intervention Type: OTHER

Other Intervention Names

Pharmaceutical Care

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: collaborator

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tajunisah Mohamed Eusoff

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Balamurugan Tangiisuran, PhD

Role: STUDY_DIRECTOR

Universiti Sains Malaysia

Locations

Hospital Pulau Pinang

Pulau Pinang, , Malaysia

Countries

Malaysia

Other Identifiers

NMRR-18-3634-44321 (IIR)

Identifier Type: OTHER

Identifier Source: secondary_id

POCCP1 v1.3_10July19

Identifier Type: -

Identifier Source: org_study_id