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

NCT04175899 | Unknown

• 2 other identifiers: POCCP1 v1.3_10July19NMRR-18-3634-44321 (IIR)
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Keywords

Capecitabine; Pharmacist Intervention; Adherence; Relative Dose Intensity; Medication Knowledge; Safety

Outcome Measures

Primary Outcomes (3)

• Relative Dose Intensity - End of Treatment

  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.

  6 months

• Relative Dose Intensity - Mid Treatment

  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.

  3 months

• Daily Adherence

  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.

  6 months

Secondary Outcomes (13)

• Persistence to Treatment

  6 months

• Medication Adherence Report Scale (MARS-5) C1

  3 weeks

• Medication Adherence Report Scale (MARS-5) C4

  3 months

• Medication Adherence Report Scale (MARS-5) C8

  6 months

• Capecitabine Medication Taking Behavior Questionnaire C1

  3 weeks

Study Arms (2)

POCCP (Pharmacist-led Oral Chemo Care Program)

EXPERIMENTAL

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)

Other: Pharmacist-led Oral Chemo Care Program (POCCP)

SBC (Current Standard Best Care)

NO INTERVENTION

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.

Interventions

Pharmacist-led Oral Chemo Care Program (POCCP) 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.

Also known as: Pharmaceutical Care

POCCP (Pharmacist-led Oral Chemo Care Program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead
• Universiti Sains Malaysia: collaborator

Study Sites (1)

Hospital Pulau Pinang

Pulau Pinang, 10400, Malaysia

Location

MeSH Terms

Interventions

Pharmaceutical Services

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Balamurugan Tangiisuran, PhD

  Universiti Sains Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 25, 2019
• Study Start: December 10, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)