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

Solid Tumor, Adult Clinical Trial

— POCCP1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04175899
• Other study ID #: POCCP1 v1.3_10July19
• Secondary ID: NMRR-18-3634-443
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: November 2021

Study information

• Verified date: March 2021
• Source: Ministry of Health, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Malaysia	Hospital Pulau Pinang	Pulau Pinang

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia	Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Persistence to Treatment	Persistence to Treatment defined as percentage of patient completed 8 cycle of treatment (each cycle is 21 days).	6 months
Secondary	Medication Adherence Report Scale (MARS-5) C1	MARS-5 score will be assessed at the end of Cycle 1 (each cycle is 21 days). Medication Adherence Report Scale (MARS-5) Questionnaire consists of five questions on patterns of nonadherent behaviour to assess patients self-reported adherence to oral capecitabine. Scoring is on a 5-point Likert scale and total score range between 5 and 25 whereby a higher scores means better adherence.	3 weeks
Secondary	Medication Adherence Report Scale (MARS-5) C4	MARS-5 score will be assessed at the end of Cycle 4 (each cycle is 21 days). Medication Adherence Report Scale (MARS-5) Questionnaire consists of five questions on patterns of nonadherent behaviour to assess patients self-reported adherence to oral capecitabine. Scoring is on a 5-point Likert scale and total score range between 5 and 25 whereby a higher scores means better adherence.	3 months
Secondary	Medication Adherence Report Scale (MARS-5) C8	MARS-5 score will be assessed at the end of Cycle 4 (each cycle is 21 days). Medication Adherence Report Scale (MARS-5) Questionnaire consists of five questions on patterns of nonadherent behaviour to assess patients self-reported adherence to oral capecitabine. Scoring is on a 5-point Likert scale and total score range between 5 and 25 whereby a higher scores means better adherence.	6 months
Secondary	Capecitabine Medication Taking Behavior Questionnaire C1	Capecitabine Medication Taking Behavior (CMTB) will be assessed at the end of Cycle 1 (each cycle is 21 days).; The questionnaire consists of four questions to further identify aspects of patients non-adherence, their medication-taking and medication-stopping behavior specific for oral capecitabine. Scoring is on a 5-point Likert scale and total score range between 5 and 20 whereby a higher scores means better adherence.	3 weeks
Secondary	Capecitabine Medication Taking Behavior Questionnaire C4	Capecitabine Medication Taking Behavior (CMTB) will be assessed at the end of Cycle 4 (each cycle is 21 days).; The questionnaire consists of four questions to further identify aspects of patients non-adherence, their medication-taking and medication-stopping behavior specific for oral capecitabine. Scoring is on a 5-point Likert scale and total score range between 5 and 20 whereby a higher scores means better adherence.	3 months
Secondary	Capecitabine Medication Taking Behavior Questionnaire C8	Capecitabine Medication Taking Behavior (CMTB) will be assessed at the end of Cycle 8 (each cycle is 21 days).; The questionnaire consists of four questions to further identify aspects of patients non-adherence, their medication-taking and medication-stopping behavior specific for oral capecitabine. Scoring is on a 5-point Likert scale and total score range between 5 and 20 whereby a higher scores means better adherence.	6 months
Secondary	Change in Chemotherapy Knowledge & Self-Efficiency C1	Change in Chemotherapy Knowledge & Self-Efficiency will be assessed at the end of Cycle 1 (3 weeks) from baseline (week 0). Each cycle is 21 days Patients chemotherapy knowledge and self-efficiency level will be assessed using a structured question set.	3 weeks
Secondary	Change in Chemotherapy Knowledge & Self-Efficiency C4	Change in Chemotherapy Knowledge & Self-Efficiency will be assessed at the end of Cycle 4 (3 months) from baseline (week 0). Each cycle is 21 days Patients chemotherapy knowledge and self-efficiency level will be assessed using a structured question set.	3 months
Secondary	Change in Chemotherapy Knowledge & Self-Efficiency C8	Change in Chemotherapy Knowledge & Self-Efficiency will be assessed at the end of Cycle 8 (6 months) from baseline (week 0). Each cycle is 21 days Patients chemotherapy knowledge and self-efficiency level will be assessed using a structured question set.	6 months
Secondary	Change in Adverse Drug Events (ADE) - Toxicity Score	Change in Toxicity Score will be assessed at the end of Cycle 8 (6 months) from baseline (week 0). Each cycle is 21 days Incidence and severity grading of adverse events related to chemotherapy, will be measured by the reviewing doctor for the duration of treatment follow-up using a standardized ADE monitoring checklist based on the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 grading scale.	6 months
Secondary	Drug Related Problem (DRP) and Pharmacist Intervention	Frequency of DRPs identified during the study will be reported using the Pharmaceutical Care Network Europe (PCNE) classification scheme v8.01	6 month
Secondary	Health service utilization	Frequency of hospital services utilizations of the patients will be measured for emergency department visit, unplanned oncology clinic or outpatient visits, hospital admissions or had phone calls to oncology clinic.	6 month