Clinical Pharmacists' Intervention on Pain Management in Cancer Patients

NCT ID: NCT05021393

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-06-01

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.

Conditions

Cancer; Cancer Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Clinical Pharmacist Intervention

Intervention Type: OTHER

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

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clinical Pharmacist Intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monash University Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Sunil Shrestha

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunil Shrestha

Role: PRINCIPAL_INVESTIGATOR

Monash University Malaysia

Locations

Kathmandu Cancer Center

Bhaktapur, Bagmati, Nepal

Civil Service Hospital

Kathmandu, Bagmati, Nepal

Countries

Nepal

References

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.

Reference Type: BACKGROUND

PMID: 36694232 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39601933 (View on PubMed)

Other Identifiers

PharmaCAP trial

Identifier Type: -

Identifier Source: org_study_id