Clinical pharmacists’ intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trial

Abstract Introduction Evidence-based services to support cancer patients with pain via clinical pharmacy services are currently lacking. Therefore, there is a need to undertake a randomized controlled trial (RCT) to explore the effectiveness of clinical pharmacists (CPs)’ input into the multidiscipl...

Full description

Bibliographic Details
Main Authors: Sunil Shrestha, Ali Qais Blebil, Siew Li Teoh, Simit Sapkota, Bhuvan KC, Vibhu Paudyal, Siew Hua Gan
Format: Article
Language:English
Published: Taylor & Francis Group 2023-01-01
Series:Journal of Pharmaceutical Policy and Practice
Subjects:
Online Access:https://doi.org/10.1186/s40545-022-00505-0
_version_ 1797329546515578880
author Sunil Shrestha
Ali Qais Blebil
Siew Li Teoh
Simit Sapkota
Bhuvan KC
Vibhu Paudyal
Siew Hua Gan
author_facet Sunil Shrestha
Ali Qais Blebil
Siew Li Teoh
Simit Sapkota
Bhuvan KC
Vibhu Paudyal
Siew Hua Gan
author_sort Sunil Shrestha
collection DOAJ
description Abstract Introduction Evidence-based services to support cancer patients with pain via clinical pharmacy services are currently lacking. Therefore, there is a need to undertake a randomized controlled trial (RCT) to explore the effectiveness of clinical pharmacists (CPs)’ input into the multidisciplinary team (MDT) in providing better therapeutic outcomes for cancer pain management. Objectives The main aim of this pilot RCT is to determine the feasibility and preliminary efficacy of integrating CPs into the MDT for cancer pain management on the clinical outcomes of cancer patients experiencing pain. Methods This study protocol outlines two-armed multicenter pilot RCT. Cancer patients suffering from pain will be randomly allocated to receive either clinical pharmacy services, i.e., PharmaCAP trial intervention from the CP, or the usual standard care (i.e., control group). Patients will be recruited consecutively from two hospitals in Kathmandu valley, Nepal. The outcomes will be assessed at baseline (pre-intervention) and 4 weeks post-intervention. The primary feasibility outcomes will include eligibility rate, recruitment rate, willingness to participate, acceptability of screening procedures and random allocation, possible contamination between the groups, intervention fidelity and compliance, treatment satisfaction, and patient understanding of the provided interventions. Subsequently, the primary clinical outcome, i.e., pain intensity of cancer patients, will be assessed. The secondary clinical outcomes will include health-related quality of life (HRQoL), anxiety, depression, adverse drug reactions, and patient medication compliance following the integration of CP into the healthcare team. Discussion The feasibility and potential for integrating CP involvement in MDT to improve clinical outcomes of cancer patients with pain will be evaluated through the PharmaCAP trial. Trial registration: ClinicalTrials.gov NCT05021393. Registered on 25th August 2022.
first_indexed 2024-03-08T07:07:05Z
format Article
id doaj.art-bd4a40be91de47c88d2a233c8c9a3899
institution Directory Open Access Journal
issn 2052-3211
language English
last_indexed 2024-03-08T07:07:05Z
publishDate 2023-01-01
publisher Taylor & Francis Group
record_format Article
series Journal of Pharmaceutical Policy and Practice
spelling doaj.art-bd4a40be91de47c88d2a233c8c9a38992024-02-03T04:31:34ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112023-01-0116111210.1186/s40545-022-00505-0Clinical pharmacists’ intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trialSunil Shrestha0Ali Qais Blebil1Siew Li Teoh2Simit Sapkota3Bhuvan KC4Vibhu Paudyal5Siew Hua Gan6School of Pharmacy, Monash University MalaysiaSchool of Pharmacy, Monash University MalaysiaSchool of Pharmacy, Monash University MalaysiaDepartment of Clinical Oncology, Kathmandu Cancer CenterSchool of Pharmacy, Monash University MalaysiaSchool of Pharmacy, College of Medical and Dental Sciences, Sir Robert Aitken Institute for Medical Research, University of Birmingham EdgbastonSchool of Pharmacy, Monash University MalaysiaAbstract Introduction Evidence-based services to support cancer patients with pain via clinical pharmacy services are currently lacking. Therefore, there is a need to undertake a randomized controlled trial (RCT) to explore the effectiveness of clinical pharmacists (CPs)’ input into the multidisciplinary team (MDT) in providing better therapeutic outcomes for cancer pain management. Objectives The main aim of this pilot RCT is to determine the feasibility and preliminary efficacy of integrating CPs into the MDT for cancer pain management on the clinical outcomes of cancer patients experiencing pain. Methods This study protocol outlines two-armed multicenter pilot RCT. Cancer patients suffering from pain will be randomly allocated to receive either clinical pharmacy services, i.e., PharmaCAP trial intervention from the CP, or the usual standard care (i.e., control group). Patients will be recruited consecutively from two hospitals in Kathmandu valley, Nepal. The outcomes will be assessed at baseline (pre-intervention) and 4 weeks post-intervention. The primary feasibility outcomes will include eligibility rate, recruitment rate, willingness to participate, acceptability of screening procedures and random allocation, possible contamination between the groups, intervention fidelity and compliance, treatment satisfaction, and patient understanding of the provided interventions. Subsequently, the primary clinical outcome, i.e., pain intensity of cancer patients, will be assessed. The secondary clinical outcomes will include health-related quality of life (HRQoL), anxiety, depression, adverse drug reactions, and patient medication compliance following the integration of CP into the healthcare team. Discussion The feasibility and potential for integrating CP involvement in MDT to improve clinical outcomes of cancer patients with pain will be evaluated through the PharmaCAP trial. Trial registration: ClinicalTrials.gov NCT05021393. Registered on 25th August 2022.https://doi.org/10.1186/s40545-022-00505-0Cancer painCancer patientsClinical pharmacistFeasibility studyPilot trialRandomized controlled trial
spellingShingle Sunil Shrestha
Ali Qais Blebil
Siew Li Teoh
Simit Sapkota
Bhuvan KC
Vibhu Paudyal
Siew Hua Gan
Clinical pharmacists’ intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trial
Journal of Pharmaceutical Policy and Practice
Cancer pain
Cancer patients
Clinical pharmacist
Feasibility study
Pilot trial
Randomized controlled trial
title Clinical pharmacists’ intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trial
title_full Clinical pharmacists’ intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trial
title_fullStr Clinical pharmacists’ intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trial
title_full_unstemmed Clinical pharmacists’ intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trial
title_short Clinical pharmacists’ intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trial
title_sort clinical pharmacists intervention on pain management in cancer patients pharmacap trial study protocol for a randomized controlled trial
topic Cancer pain
Cancer patients
Clinical pharmacist
Feasibility study
Pilot trial
Randomized controlled trial
url https://doi.org/10.1186/s40545-022-00505-0
work_keys_str_mv AT sunilshrestha clinicalpharmacistsinterventiononpainmanagementincancerpatientspharmacaptrialstudyprotocolforarandomizedcontrolledtrial
AT aliqaisblebil clinicalpharmacistsinterventiononpainmanagementincancerpatientspharmacaptrialstudyprotocolforarandomizedcontrolledtrial
AT siewliteoh clinicalpharmacistsinterventiononpainmanagementincancerpatientspharmacaptrialstudyprotocolforarandomizedcontrolledtrial
AT simitsapkota clinicalpharmacistsinterventiononpainmanagementincancerpatientspharmacaptrialstudyprotocolforarandomizedcontrolledtrial
AT bhuvankc clinicalpharmacistsinterventiononpainmanagementincancerpatientspharmacaptrialstudyprotocolforarandomizedcontrolledtrial
AT vibhupaudyal clinicalpharmacistsinterventiononpainmanagementincancerpatientspharmacaptrialstudyprotocolforarandomizedcontrolledtrial
AT siewhuagan clinicalpharmacistsinterventiononpainmanagementincancerpatientspharmacaptrialstudyprotocolforarandomizedcontrolledtrial