Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Cancer Pain

Pain

Neurologic Manifestations

Quality of Life

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

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.

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

Clinical Pharmacist Intervention

Sunil Shrestha

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.

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.

Clinical Pharmacists' Intervention on Pain Management in Cancer Patients

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)

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.

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.

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.

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.

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).

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)

Monash University Malaysia

Principal Investigator

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist

Participants randomized to observational arm will receive usual care.

Multidisciplinary team intervention

People with breast cancer often experience many short and long-term side effects as a result of both the cancer and the necessary treatments.

Receiving extra assessments and care from teams of multiple health professionals has been shown to be helpful for people with other health problems, such as heart disease. These 'multidisciplinary' teams may include nurses, doctors, pharmacists, dietitians, exercise therapists, counselors, and other specialists. Currently, the investigators do not know if receiving extra assessments from a multidisciplinary team is helpful for people receiving cancer treatment.

In this study, the investigators hope to learn the effect of extra assessments and early interventions from teams of health care professionals in people diagnosed with cancer, during and after the treatment period.

After initial assessments, participants will be randomized to multidisciplinary team intervention or usual care.

Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)

Multidisciplinary Team IntervenTion in CArdio-ONcology

nutrition, exercise, physiotherapy interventions

left ventricular ejection fraction (LVEF)

percent change in established biomarkers (troponin, BNP)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Pharmacists' Intervention on Pain Management in Cancer Patients	NCT05021393	Cancer Cancer Pain	Clinical Pharma...	18 Years -	Monash University Malaysia
Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)	NCT01621659	Breast Cancer	Multidisciplina...	18 Years -	University of Alberta
Clinical Pharmacists' Intervention on Pain Management in Cancer Patients	NCT05021393	Cancer Cancer Pain	Clinical Pharma...	18 Years -	Monash University Malaysia

Spots Global Cancer Trial Database for multidisciplinary team