Solid Tumor, AdultPOCCP1NCT04175899
Effectiveness of Pharmacist Intervention on Capecitabine Relative Dose Intensity, Adherence, Knowledge & Safety Among Cancer Patients in Malaysia
A study testing Pharmacist-led Oral Chemo Care Program (POCCP) in people with Solid Tumor, Adult, run by Ministry of Health, Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Pharmacist-led Oral Chemo Care Program (POCCP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Dec 2019to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Pharmacist Intervention on Capecitabine Relative Dose Intensity, Adherence, Knowledge & Safety Among Cancer Patients in Malaysia.
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.
Read more
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
- Being tested
- Pharmacist-led Oral Chemo Care Program (POCCP)
- Keywords
- Capecitabine, Pharmacist Intervention, Adherence, Relative Dose Intensity, Medication Knowledge, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led Oral Chemo Care Program (POCCP)Other
Also called Pharmaceutical Care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (13)
Persistence to Treatment
Persistence to Treatment defined as percentage of patient completed 8 cycle of treatment (each cycle is 21 days).
Measured: 6 months
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.
Measured: 3 weeks
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 3 weeks
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 3 weeks
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 month
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start10 Dec 2019
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Collaborators
- Universiti Sains Malaysia
- Responsible party
- Principal investigator, Tajunisah Mohamed Eusoff, Ministry of Health, Malaysia
- Investigators
- Balamurugan Tangiisuran, PhD, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175899
- Sponsor's protocol ID
- POCCP1 v1.3_10July19
- Other IDs
- NMRR-18-3634-44321 (IIR)
- Acronym
- POCCP1
- Status last verified
- Mar 2021
- First submitted
- 19 Nov 2019
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pharmacist Intervention on Capecitabine Relative Dose Intensity, Adherence, Knowledge & Safety Among Cancer Patients in Malaysia.
- ClinicalTrials.gov ID
- NCT04175899
- Acronym / sponsor ID
- POCCP1 / POCCP1 v1.3_10July19
- Conditions
- Solid Tumor, Adult
- Keywords
- Capecitabine, Pharmacist Intervention, Adherence, Relative Dose Intensity, Medication Knowledge, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Collaborators
- Universiti Sains Malaysia
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCCP (Pharmacist-led Oral Chemo Care Program) | Experimental | Other: Pharmacist-led Oral Chemo Care Program (POCCP)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) |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led Oral Chemo Care Program (POCCP)Also: Pharmaceutical CareStructured 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. | Other | POCCP (Pharmacist-led Oral Chemo Care Program) |
Primary outcome
Relative Dose Intensity - End of Treatment
Time frame: 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.
Relative Dose Intensity - Mid Treatment
Time frame: 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
Time frame: 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.
13 secondary outcomes
Persistence to Treatment
Time frame: 6 months
Medication Adherence Report Scale (MARS-5) C1
Time frame: 3 weeks
Medication Adherence Report Scale (MARS-5) C4
Time frame: 3 months
Medication Adherence Report Scale (MARS-5) C8
Time frame: 6 months
Capecitabine Medication Taking Behavior Questionnaire C1
Time frame: 3 weeks
Capecitabine Medication Taking Behavior Questionnaire C4
Time frame: 3 months
Capecitabine Medication Taking Behavior Questionnaire C8
Time frame: 6 months
Change in Chemotherapy Knowledge & Self-Efficiency C1
Time frame: 3 weeks
Change in Chemotherapy Knowledge & Self-Efficiency C4
Time frame: 3 months
Change in Chemotherapy Knowledge & Self-Efficiency C8
Time frame: 6 months
Change in Adverse Drug Events (ADE) - Toxicity Score
Time frame: 6 months
Drug Related Problem (DRP) and Pharmacist Intervention
Time frame: 6 month
Health service utilization
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balamurugan Tangiisuran, PhD study director
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led Oral Chemo Care Program (POCCP) in people with Solid Tumor, Adult, run by Ministry of Health, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Dose Intensity - End of Treatment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.