An interventional study of Pharmacist-led Oral Chemo Care Program (POCCP) in Solid Tumor, Adult, sponsored by Ministry of Health, Malaysia. Status unknown at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-08.
Sponsored by Ministry of Health, Malaysia · Not applicable, Interventional, and Supportive care
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.
Ministry of Health, Malaysia is the lead sponsor of 27 studies on the registry; none are open to participants now.
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Patients will be screened according to the inclusion criteria below;
Exclusion Criteria:
The following patients will be excluded from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Persistence to Treatment
Persistence to Treatment defined as percentage of patient completed 8 cycle of treatment (each cycle is 21 days).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 6 month
Plan to share: No
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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Malaysia