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

Rare Diseases

Chronic Pain

Chronic Graft Versus Host Disease

Participants will attend online group class/week for eight consecutive weeks. The MBSR will be based on the program adapted by the Multidisciplinary Pain Centre at Rigshospitalet (DK), which is tailored to patients with chronic pain. Each session has duration of 1.5 hours. Content is composed by meditation techniques and physical exercises, which focus on increasing awareness and acceptance of moment-to-moment experiences, including physical discomfort and difficult emotions.Two groups of 11-12 patients will be composed. However, individual meetings may be organized if the recruitment process shows difficulties to gather patients in groups. It will be delivered by a certified MBSR therapist and via Teams platform.

VRPS is based on four evidence-based principles of cognitive-behavioral therapy and pain neuroscience education. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules.The eight consecutive weeks program period of intervention is composed of one initial physical meeting with 1h duration to explain the basis/principles of the virtual tools offered, how the virtual appliance works and should be used, including safety recommendations as calm environment at home, sitting or lying position during use. Groups of maximum 13 patients will be organized. Patients will be instructed to use the equipment at least once a day and it can be used as many times as they wish per day aiming to reduce pain intensity or to avoid pain. Patients will also be asked to keep a diary to register the equipment use during the study period to secure the data.

Participants in the control group will not receive any of the interventions. This study will not interfere with medical treatment plan and patients from the three groups can receive other pain treatment prescribed by physician.

Online group class/week for eight consecutive weeks with 8 sessions

Online Mindfullness Based Stress Reduction Program

The VRPS has a variety of modules that can be used for pain management. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules. All modules were designed to minimize triggers of emotional distress or cybersickness.

Virtual Reality-based Pain Self-management program

Geana Kurita, PhD

Suzanne F Forsyth Herling, PhD

This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): Mindfulness Based Stress Reduction (MBSR) group, Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 78 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.

Considering the need of interventions to improve pain self-management to interrupt the "pain chronification" process and the indications regarding advantages of cognitive behavioral techniques and technologic resources, the purpose of this study is to test homebased interventions connecting these two areas. Here, the effects of an online delivered standardized mindfulness-based stress reduction program and non-pharmacological techniques delivered through a virtual reality-based pain self-management program will be tested in patients with non-cancer pain lasting three months or more. Both interventions target primarily pain relief by providing pain regulating strategies.

The investigators will test the main hypothesis that participants assigned to Mindfulness-Based Stress Reduction (MBSR) or Virtual Reality-based Pain Self-management program (VRPS) present reduction of pain intensity among other outcomes at 2 months post-intervention as well as after 6-, 9-, and 12-months follow-up when compared to treatment as usual (control group).The primary aim is to investigate the effects of MBSR and VRPS on worst pain intensity in the last 24h in patients with non-cancer pain lasting 3 months or more at 2 months post-intervention.The secondary aims are to analyze the effects of both interventions on other patient-reported outcomes measures (PROMs), which are pain intensity at follow-ups, pain interference in daily activities, pain catastrophizing, pain acceptance, health-related quality of life, anxiety, depression, perceived change on over-all pain status, use of analgesic medication, and use of health care system among patients with non-cancer pain lasting 3 months or more. In addition, the effects of the two interventions will be compared.

This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): MBSR group, VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention.

The statistical analysis of the data will be blinded

Preventive Interventions for Chronic Pain Worsening

Satisfaction with the interventions will be asked to the intervention groups by general questions about the intervention experienced with answers in a 6-point scale (0=completely dissatisfied to 5= completely satisfied) and there will be space to write comments.

Pain intensity for worst pain in the last 24h: Brief Pain Inventory to measure pain intensity, from no pain (0) to worst pain ever (10)

Brief Pain Inventory to measure pain intensity from no pain (0) to worst pain ever (10) at follow-ups and interference on general activity, mood, walking ability, work, social relations, sleep, and enjoyment of life

Pain Catastrophizing Scale, using a 5-point Likert scale ranging from 0 (never) to 4 (always) to assess patterns of negative cognition and emotion in the context of actual or anticipated pain

Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score, using a rating scale from 0 to 6. Never true (0) to always true (6)

patient-generated outcome assessed by the Measure Yourself Medical Outcome Profile (MYMOP2), which measures effects from health care interventions on physical, emotional, or social symptoms/problems. It is problem-specific and includes general wellbeing

Physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health using the RAND 36-Item Short Form Health Survey version 1.0. First, precoded numeric values are recoded per the scoring key. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity. Measured on a rating scale,- "from not at all" (0) to "almost every day" (3)

Patient Health Questionnaires scale (PHQ-9) can help track a patient's overall depression severity as well as track the improvement of specific symptoms with treatment. Measured on a rating scale,- from "not at all" (0) to "almost every day" (3)

Medication used (type and quantity) The information collected will refer to the period from patient inclusion to up one year follow-up.

The number of times that he/she used the health care system because of his chronic pain problem and treatment received (pharmacologic, surgical, rehabilitation, etc.). The information collected will refer to the period from patient inclusion to up one year follow-up.

Number of absent days at work because of pain will be asked directly to the patients through the electronic forms. The information collected will refer to the period from patient inclusion to up one year follow-up.

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
Preventive Interventions for Chronic Pain Worsening	NCT06351046	Chronic Non-Can...	Online Mindfull... Virtual Reality...	18 Years -	Rigshospitalet, Denmark
Clinical Pharmacists' Intervention on Pain Management in Cancer Patients	NCT05021393	Cancer Cancer Pain	Clinical Pharma...	18 Years -	Monash University Malaysia
Preventive Interventions for Chronic Pain Worsening	NCT06351046	Chronic Non-Can...	Online Mindfull... Virtual Reality...	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for pain intensity