AzTrials
AzTrials

CancerPharmCaPNCT05021393

Clinical Pharmacists' Intervention on Pain Management in Cancer Patients

A study testing Clinical Pharmacist Intervention in people with Cancer and Cancer Pain, run by Monash University Malaysia at 2 sites in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Cancer Pain
What is being tested?
Clinical Pharmacist Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
2 sitesNepal
Study dates
1 May 2022to 1 Jun 2023
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 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Nepal2 sites

  • Kathmandu Cancer Center

    Bhaktapur, Bagmati, 977

  • Civil Service Hospital

    Kathmandu, Bagmati, 977

Other trials in Nepal

About this study

Official title: Impact of Clinical Pharmacist Intervention as a Part of the Multidisciplinary Team on Clinical Outcomes in Cancer Patients With Pain in Nepal: A Feasibility Pilot Randomized Controlled Trial (PharmCaP Trial)

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.

Read the detailed description

For the intervention group, medication review, patient education, counseling, and recommendation will be performed by clinical pharmacists for all randomized patients. Patient education and counseling include giving education regarding drugs used in pain management, their adverse drug reactions. Medication review includes assessing the appropriateness of each of the regular medications based on laboratory findings, medication lists, consultation and discharge notes, procedures, and test results. Face-to-face interviews will be conducted with patients prior to the follow-up. Clinical pharmacists will assess drug use history used for pain management, identify drug-related problems, identify ADRs and provide drug therapy interventions through written pharmacist notes to physicians during the follow-up, based on the medication chart review and the above pharmaceutical assessments.

After the follow-up, the clinical pharmacist will educate on drug-related problems identified before the visit, reinforce physician's instruction, and encourage drug compliance using written patient educational leaflets. Telephone follow follow-up will be conducted 4 weeks after the visit. Patients randomized to the control group will attend the medical follow-up as usual and receive usual care. All patients will be followed up for 4 weeks post-intervention visits. Data collection will be conducted at baseline and 4 weeks after the pharmacist visit. The primary outcome of the study is pain intensity which will be measured at baseline (prior to physician visit), and at 4 weeks post-intervention follow-up.

Patients will be encouraged to keep in touch with the clinical pharmacist through various communication tools (including short messages, mobile phone contact, or Viber or WhatsApp). They will be also encouraged to request a consultation for any pain control issue at any time.

This prospective randomized controlled trial will be conducted in the cancer hospitals of Nepal.

Conditions
Cancer, Cancer Pain
Being tested
Clinical Pharmacist Intervention
Keywords
cancer, cancer pain, clinical pharmacist, multidisciplinary team, pain intensity, quality of life
Medical subject headings
Neoplasms, Cancer Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical Pharmacist InterventionOther

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

Study groups in NCT05021393
Study groupRoleWhat they receive
Intervention GroupExperimentalThe intervention group will receive the services from a clinical pharmacist and the existing standard care available in the medical oncology ward.
Receives: Other: Clinical Pharmacist Intervention
Control GroupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (5)

  1. Change in Quality of life

    EORTC QLQ-C30 (Version 3) uses for questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

    The EORTC QLQ-C30 (Version 3) uses for questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, the raw score has to be calculated with mean values. An afterward linear transformation is performed to be comparable. More points are considered to have a better outcome.

    Measured: 4 weeks

  2. Edmonton Symptom Assessment System (revised version)

    The revised Edmonton Symptom Assessment System (ESAS-r) is designed to assess 10 common symptoms: pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, well-being, and constipation.

    The patient circles the most appropriate number to indicate where the symptom is between "0" and "10". "0" is the minimum value, which means there is no change and it is a better outcome for the patient. "10" is the maximum value, which means that the symptom level is the highest, which is a worse outcome for the patient.

    Measured: 4 weeks

  3. Adverse Drug Reaction

    Adverse events will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. Number of subjects who experienced an adverse event in this study is presented.

    Measured: 4 weeks

  4. Medication Adherence

    Medication Adherence Report Scale-5 (MARS-5): Changes in self-reported adherence using the MARS-5 at 4 weeks post-baseline. The MARS-5 assesses adherence to treatment.

    The MARS-5 assesses a patient's typical medication adherence through 5 questions (eg, "I forget to take my medication"; "I alter the dose of my medication"), using a 5-level response format (1-always, 2-often, 3-sometimes, 4-rarely, and 5-never).

    Measured: 4 weeks

  5. Hospital Anxiety and Depression

    Hospital Anxiety and Depression Scale (HADS): The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems.

    The HADS includes 14 items assessing anxiety (7-item) and depression (7-item), which are rated on a 4-point Likert-type (from 0 to 3). The scores in each subscale are computed by summing the corresponding items, with maximum scores of 21 for each subscale. A score of 0-7 is considered as normal, 8-10 as a borderline case, and 11-21 as a case (anxiety or depression)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start1 May 2022
  3. Primary completion28 Jan 2023
  4. Study completion1 Jun 2023

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05021393
Sponsor's protocol ID
PharmaCAP trial
Acronym
PharmCaP
Status last verified
Mar 2024
First submitted
17 Aug 2021
Last updated
26 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36694232

  • 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.

    PubMed 39601933

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Pharmacist Intervention in people with Cancer and Cancer Pain, run by Monash University Malaysia at 2 sites in Nepal.

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 6 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: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Nepal. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pain Intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05021393, which also lists 2 linked publications.

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 26 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in