Home » Trials » SLCTR/2020/002

Impact of a ward-based clinical pharmacy service on quality of life and use of medicines among oncology patients in Sri Lanka: A Randomized control trial


SLCTR Registration Number


Date of Registration

20 Jan 2020

The date of last modification

Jan 20, 2020

Application Summary

Scientific Title of Trial

Impact of a ward-based clinical pharmacy service on quality of life and use of medicines among oncology patients in Sri Lanka: A Randomized control trial

Public Title of Trial

A randomized controlled trial to evaluate the effectiveness of clinical pharmacy service on improving the quality of life and use of medicines in oncology patients at the National Cancer Institute in Sri Lanka.

Disease or Health Condition(s) Studied


Scientific Acronym


Public Acronym


Brief title

Role of clinical pharmacist in an oncology ward

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

P/130/06/2019 (ERC Kelaniya)

Trial Details

What is the research question being addressed?

Could a clinical pharmacy service improve the quality of life and use of medicines among oncology patients admitted to the National Cancer Institute, Sri Lanka?

Type of study


Study design


Randomized controlled trial


Single blinded : Data analysts, Healthcare providers


Standard therapy/practice




Health services research

Study Phase

Not Applicable

Intervention(s) planned

The study will be carried out in two medical oncology wards at National Cancer Institute, Sri Lanka. The study will be carried out for the period of one year. Within the time period participant recruitment, intervention and six months follow-up will be done.

• During the 1st phase, the male ward will house the intervention group and the female ward will house the control group (Patient recruitment will be carried out until the sample size reaches 44 for each group). • There will be a washout period to minimize cross-contamination. The washout period will not have a fixed period and will be adjusted according to the duration of the treatment cycle of each patient. Precautions will be taken to ensure that all patients assigned to each group previously will not overlap at the time of the swap between wards. • During the 2nd phase, the female ward will house the intervention group and the male ward will house the control group. (Patient recruitment will be carried out until the sample size reaches 44 for each group). At the end of the study each arm will have 88 oncology patients.

Patient recruitment within a single ward will follow a simple randomization process using a computer-generated random sequence (patients within the "intervention" ward will be randomly allocated to the intervention group and patients within the "control" ward will be allocated randomly in to the control group).

The intervention group will receive the services from a ward-based pharmacist in addition to the existing standard care available in the medical oncology ward. The standard care includes the current existing care provided to patients in the ward. It includes all the available medical and non-medical services except the service provided by the ward-based pharmacist.

The pharmacist will carry out the following interventions. • The pharmacist will obtain a detailed medication history from the intervention group by conducting a face-to-face interview with the patient and/or caregiver on the first day of admission i.e. within 24 hours of admission. It will take approximately 15 minutes in each interview. • The pharmacist will prospectively review the hospital drug chart until the patient is discharged to identify any drug-related symptoms. The pharmacist will meet the patients daily and discuss the current clinical conditions and occurrence of new symptoms to further identify any unreported drug-related problems or adverse drug reactions. • The identified drug-related problems will be discussed with the corresponding healthcare staff to optimise the treatment. • The intervention arm will receive chemotherapy counselling by the ward-based pharmacist throughout the chemotherapy cycle three times at three phases; at baseline (before starting the chemotherapy cycle), mid of the cycle and at the end of the last cycle. Each counselling session will last approximately 15 minutes. The chemotherapy counselling mainly focuses to enhance patient awareness regarding the following aspects. -Purpose of the chemotherapy treatment -The goal and benefits of chemotherapy -The name, dosing schedules, duration (number of cycles planned and length of the treatment) and types of chemotherapy -The potential side effects patients can experience during and later of the treatment -How the patient can manage or ease these side effects (foods to help with side effects) -When does the patient need to notify the doctor about the side effects. -How does the treatment affect his/her daily routine life (Ex: Can I work during chemotherapy?)

• The pharmacist will provide drug information to the medical staff and nursing staff when needed.

The intervention will be provided by one pharmacist (intervention pharmacist) and the outcomes will be assessed independently by another pharmacist (assessment pharmacist).”

Inclusion criteria

  1. Patients age 18 years old or above
  2. Male and female patients
  3. Patients diagnosed with cancer at any stage by an oncologist
  4. Patients undergoing their 1st and 2nd cycles of chemotherapy

Exclusion criteria

  1. Patients re-admitted during the study period
  2. Patients with poor cognition with no caregiver to manage medicines
  3. Patients who unable/unwilling to give informed written consent
  4. Patients who already undergone 3rd cycle of chemotherapy onwards
  5. Patients who have speech and communication disorders

Primary outcome(s)


The improvement of quality of life (QOL) among patients with oncology as assessed by the mean score difference of EORTC QLQ-C30.

QOL assessment will be done using standard EORTC QLQ-C30 (version 3.0) questionnaire. The QLQ-C30 questionnaire is a self-administered tool which comprises nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.


At their baseline (before starting the chemotherapy cycle), middle of the cycle and at end of the cycle (1 week after the last cycle)


Secondary outcome(s)


Mean Medication Appropriateness Index (MAI) will be compared between the control and intervention groups at the discharge in order to assess the appropriateness of discharge prescriptions.


Within hospital stay and at the discharge.


Mean pain severity score will be measured at two intervals (on admission and at discharge) between both control and intervention groups in order to assess effectiveness of the treatment and further necessity of dose modifications of the prescribed medicines.


During hospital stay (admission and discharge of each patient)


The percentage of resolution of drug-related problems in both groups during the hospital stay.


During hospital stay


The percentage of occurrence of adverse drug reactions between the two groups during the hospital stay.


During hospital stay


Change in mean score of knowledge, attitude and practice on chemotherapy among both groups.


Before start and the end of the chemotherapy cycle.


The percentage of drug-related hospital re-admissions for six months follow-up period.


Six months from the recruitment.


The cost avoidance generated by pharmacist intervention will be interpreted as net cost-benefit and cost-benefit ratio.


During hospital stay


The mean satisfaction score of patients on ward-based pharmacy service will be measured at discharge.


At discharge of patient (During hospital stay).


The percentage of acceptance of the ward-based pharmacy service by the doctors and nurses in the wards will be assessed at the baseline and at the end of the study.


At the beginning and the end of the project.


Target number/sample size

176, 88 in each arm

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source


Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama, Sri Lanka.
Email: ercmed@kln.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. S.F. Jayamanne
Senior Lecturer
Department of Medicine, Faculty of Medicine, University of Kelaniya, PO Box 6, Thalagolla Road, Ragama, Sri Lanka.


Contact Person for Public Queries

Ms. L.G.T. Shanika
Senior Lecturer
Department of Pharmacy and Pharmaceutical Sciences, Faculty of Allied Health Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda



Primary study sponsor/organization

Faculty of Medicine, University of Kelaniya

PO Box 6, Thalagolla Road, Ragama, Sri Lanka.

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

All individual participant data collected during the trial, after de-identification will be shared upon request. The study protocol and the statistical analysis plan will be shared. Data will be shared following publication of the results. Data will be shared among investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve the aims in an approved proposal and for individual participant data meta-analysis. Proposals should be directed to shalukajaya@yahoo.com To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication at the University data warehouse but without investigator support other than deposited meta-data. Information regarding submitting proposals and accessing data may be found by e-mailing me at shalukajaya@yahoo.com.

Study protocol available


Protocol version and date

Version 01, 27.06.2019

Protocol URL

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results