Clinical trial NCT05021393: Clinical Pharmacists' Intervention on Pain Management in Cancer Patients
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cancer Pain
Keywords: cancer
cancer pain
clinical pharmacist
multidisciplinary team
pain intensity
quality of life
Lead sponsor: Monash University Malaysia
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Pain Intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Quality of life
timeFrame: 4 weeks
measure: Edmonton Symptom Assessment System (revised version)
timeFrame: 4 weeks
measure: Adverse Drug Reaction
timeFrame: 4 weeks
measure: Medication Adherence
timeFrame: 4 weeks
measure: Hospital Anxiety and Depression
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bhaktapur
country: Nepal
facility: Kathmandu Cancer Center
state: Bagmati
city: Kathmandu
country: Nepal
facility: Civil Service Hospital
state: Bagmati
Study officials:
affiliation: Monash University Malaysia
name: Sunil Shrestha
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.