NCT05021393

Brief Summary

The study aims to evaluate the impact of clinical pharmacist intervention as a part of a multidisciplinary team to improve clinical outcomes of cancer patients with pain in comparison to standard care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

August 17, 2021

Last Update Submit

March 23, 2024

Conditions

CancerCancer Pain

Keywords

cancercancer painclinical pharmacistmultidisciplinary teampain intensityquality of life

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    NRS was used to assess pain intensity. The responses were given using an eleven-point numeric rating scale (NRS) scored 0-10, where 0 = best outcome/does not interfere/no pain/complete pain relief and 10 = worst outcome/completely interferes/most pain/no pain relief.

    4 weeks

Secondary Outcomes (5)

  • Change in Quality of life

    4 weeks

  • Edmonton Symptom Assessment System (revised version)

    4 weeks

  • Adverse Drug Reaction

    4 weeks

  • Medication Adherence

    4 weeks

  • Hospital Anxiety and Depression

    4 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive the services from a clinical pharmacist and the existing standard care available in the medical oncology ward.

Other: Clinical Pharmacist Intervention

Control Group

NO INTERVENTION

The standard care includes the current existing care provided to patients in the hospital. In addition, it includes all the available medical and non-medical services except the service provided by the clinical pharmacist.

Interventions

Clinical Pharmacist InterventionOTHER

Medication review, patient education, counseling, and corresponding written recommendation will be performed by clinical pharmacists for all randomized patients.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients above 18 years old, diagnosed with cancer, and had self-reported cancer pain within a month prior to the study.
  • Patients be able to read and understand the Nepalese language or English language.
  • the patient is under standard analgesia treatments.
  • the patient was estimated to have over 2 months of survival time.
  • Access to a telephone or mobile phone or internet
  • The patients must understand the study process and evaluation, agree to participate in this trial, and sign the informed.

You may not qualify if:

  • Patients who self-reported to have severe cognitive impairments.
  • Patients who are unable to complete pain assessment.
  • Participating in any other investigational therapies or other study protocols that may impact pain intensity are the primary outcomes of this study.
  • History of drug abuse, history of drug addiction, or severe alcoholism.
  • Opioid allergy.
  • Critically ill patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kathmandu Cancer Center

Bhaktapur, Bagmati, 977, Nepal

Location

Civil Service Hospital

Kathmandu, Bagmati, 977, Nepal

Location

Related Publications (2)

  • Shrestha S, Blebil AQ, Teoh SL, Sapkota S, Kc B, Paudyal V, Gan SH. Clinical pharmacists' intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trial. J Pharm Policy Pract. 2023 Jan 24;16(1):14. doi: 10.1186/s40545-022-00505-0.

    PMID: 36694232BACKGROUND

  • Shrestha S, Sapkota S, Teoh SL, Kc B, Paudyal V, Lee SWH, Gan SH. Clinical pharmacist interventions on pain management in cancer patients (PharmaCAP) in low resource settings: a multicenter feasibility-pilot randomized controlled trial. Support Care Cancer. 2024 Nov 27;32(12):828. doi: 10.1007/s00520-024-08989-z.

    PMID: 39601933DERIVED

MeSH Terms

Conditions

NeoplasmsCancer PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sunil Shrestha

    Monash University Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 25, 2021

Study Start

May 1, 2022

Primary Completion

January 28, 2023

Study Completion

June 1, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

NE(2)