Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

This is a feasibility single arm trial of Reiki for oncology participants.

Reiki, originating in Japan, is a biofield therapy where a skilled practitioner places their hands on or above the body of the recipient or themselves to induce relaxation and promote healing.

Reiki

Santosh Rao, MD

The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population.

Reiki is a biofield therapy originating in Japan, in which a trained practitioner places their hands on or above the body of a receiver or themselves to generate a relaxation and healing response. Systematic reviews and meta-analyses report Reiki to be effective for improving psychological and physical health symptoms. With respect to adults with cancer, Reiki has been shown to improve participants' relaxation, pain, fatigue, sleep, anxiety, stress, and wellbeing/quality of life compared to care as usual. However, one study showed no improvement in comfort and wellbeing in those receiving Reiki compared to sham Reiki control, but those receiving Reiki reported improvements above usual care.

Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)

When sharing IPD via open access, the lack of restrictions leads to greater risk of re-identifying individuals. Data could be inappropriately merged with other data to facilitate re-identification.The small study population makes this more likely. On the other hand, sharing IPD via controlled access is burdensome. It requires resources that the investigator does not have (setting up the infrastructure and policies, administering and reviewing data requests, preparing data and distributing data). The personnel time for such an endeavor was not budgeted nor does the investigator have the financial resources to include it in the study budget

Calculated by total number of participants enrolled/ total number of participants eligible and 90% is considered successful for the recruitment rate.

Calculated by number of participants retained until the final survey time point / number of participants enrolled. 70% of participant retention until the final survey time point will be considered successful.

Total number of sessions attended per 6 sessions. Attendance rate of \>/= 70% will be considered successful

Number of participants treated in manner consistent with intervention/total number of participants enrolled

As assessed by participants mean for the Participants' satisfaction survey with the Reiki sessions, measured on a scale from 0 (Not at all satisfied) to 10 (Completely satisfied)

Data completeness of \>/= 90% is considered satisfactory

Changes from baseline in Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Activities, Pain Interference all measured by T-score, a 11 point numerical rating scale, with higher scores representing more pain calculated from a 5 point Likert scale, with higher scores representing more of the concept being measured.

The rate of intensity of common cancer symptoms, including pain, nausea, anxiety, fatigue, and well-being as measured using ESAS scale of 0 to 10 where, 0 is no pain to 10 as worst possible pain.

Case Comprehensive Cancer Center

Gland and Hormone Related Diseases

Pituitary Diseases

Patients will receive pituitary stimulation as oncology pain treatment.

Pituitary gland stimulation via an surface electrode connected to an external neurostimulator

Pituitary gland stimulation

Wouter van Furth, MD, Phd

Wouter van Furth, MD, PhD

Patients will undergo an implantation of an extradural pituitary surface electrode in the pituitary fossa. The electrode will be attached to a neurostimulator via which the patient will receive up to 8 (patient requested) stimulations per day.

Pituitary Gland Stimulation for Cancer Pain Relief

Numeric Rating Scale (0= no pain, 10=most severe pain)

Morphine Equivalent Doses for background and escape medication

Leiden University Medical Center

neurosurgeon

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

Lidocaine, Prilocaine Drug Combination

Tetracaine

The Oculus 2 headset will be used during port access. The device features a stereoscopic display mounted on a lightweight wireless head mounted display weighing 503 g with built-in 3D audio and an adjustable head strap and adjustable lens distance. The software used will be the Might Pebbles VR Game developed by ManageXR. It is a child-friendly VR game that does not require the use of hand controllers. It also provides an option to increase the cognitive load, making it appropriate for children of all ages. The experimental group will be given up to 10 minutes to familiarize themselves with the device, assisted by the research assistant and will begin using it 5-10 minutes prior to port access. Most participants will receive topical anesthestic in the form of 4% amethocaine (Ametop), eutectic mixture of lidocaine and amethocaine (EMLA), or 4% lidocaine (Maxilene) as per standard practice at our institution. However, some participants may refuse this co-intervention.

The child will watch a video on a tablet or iPad that is appropriate for their age during port access. They will begin using it 5-10 minutes prior to port access. The content of the video will be at the discretion of the child life specialist, nurse, or caregiver. Most participants will receive topical anesthestic in the form of 4% amethocaine (Ametop), eutectic mixture of lidocaine and amethocaine (EMLA), or 4% lidocaine (Maxilene) as per standard practice at our institution. However, some participants may refuse this co-intervention.

This is no distraction or non-technologic distraction measures such as bubbles, etc., facilitated by the child life specialist, nurse, or caregiver during port access. The measure will be documented for the purposes of analysis. They will begin using it 5-10 minutes prior to port access. Most participants will receive topical anesthestic in the form of 4% amethocaine (Ametop), eutectic mixture of lidocaine and amethocaine (EMLA), or 4% lidocaine (Maxilene) as per standard practice at our institution. However, some participants may refuse this co-intervention.

VR headset will be used 5-10 minutes prior to and during port access

Virtual reality

Tablet distraction will be used 5-10 minutes prior to and during port access

Tables distraction

This approach will be used 5-10 minutes prior to and during port access

No or non-technologic distraction

Kamary Coriolano, PhD

Naveen Poonai, MD

Children with cancer almost universally receive port-a-catheters (ports) to deliver medication, fluids, blood products, and conduct blood tests. Port access requires a needle inserted through the skin to the subcutaneous tissue. Despite the application of topical anesthetic, port access can be painful and anxiety producing. Virtual reality (VR) interfaces provide a strategy to reduce anxiety and have been employed in other painful procedures in children. This trial will explore the effectiveness of VR in children undergoing port access.

Pain management in pediatric oncology patients is a core component of the care provided. Procedures and treatment administration are the greatest sources of pain for these children, often greater than the pain from the disease itself. Poor initial management for procedures can lead to anxiety and fear, along with a heightened pain response for future procedures. Sensitization, which is an increased reaction to pain, may not only occur at a physiological level, but can also psychologically affect these children, resulting in the development of a fear-avoidance response. This can impede the conduct of diagnostic testing and delivery of therapy. It can also result in an overall fear and avoidance of healthcare settings.

Port-a-caths are a medical device that is implanted below the skin, which acts as a type of venous access. They are used in pediatric oncology patients for various reasons including administration of chemotherapeutics, blood products and supportive care medication, venous sampling and diagnostic testing. At our centre, 90% of patients have a port, while the 10% remaining either have a Hickman catheter or PICC line. Acute lymphoblastic leukemia (ALL), has a treatment duration of two and half years which is facilitated by the insertion of a port-a-cath. To access a port, the area is cleaned in a sterile fashion and a needle is inserted through the skin, into the port. Ports must be flushed with heparin for line maintenance every 4-6 weeks. Currently, topical analgesics such as EMLA (lidocaine/prilocaine), and distraction methods such as interactive toys and watching videos, and anticipatory guidance are employed to help decrease the amount of pain and anxiety children encounter while their port is accessed5,6. Although topical analgesia and child life interventions may decrease the amount of procedural pain and distress, they do not fully eliminate it. Virtual Reality (VR) has been commercially available for almost 25 years, but the initially high cost prohibited widespread clinical adoption. It is being explored as a potential form of analgesia, and has been found to be effective at decreasing pain in numerous settings including in pediatric burn patients undergoing dressing changes, outpatient venipuncture, and port-cath access. The mechanism by which VR works to reduce pain is still unclear, but it has been suggested that it is through distraction. Studies using functional MRI have also shown that VR reduces pain-associated brain activity. For some children, the use of topical agents prolongs the period of distress in anticipation of port access, something, which the use of VR may diminish/eliminate.

Given that VR technology is still quite new, there have been limited studies in the use of VR in port-a-cath access. Sample sizes of previous studies investigating the use of VR in port-a-cath access have been small, ranging between 20 to 59 patients. Additional limitations include the use of non-objective, self-report and proxy measures of distress, use of a non-active comparator (no intervention), and the lack of young children (\< 7 years). However, port-a-cath access is common in young children and is often more distressing. Further, for some children the use of topical agents for access creates/prolongs period of distress to do anticipation of port-a-cath access. Behavioral measures of distress are more accurate than self-report and proxy measures. Standards of care to reduce procedural distress usually involves some type of distraction too. To optimize the external generalizability of our findings, the investigators have designed a trial to overcome these limitations, including a larger sample size, an objective measure of behavioral distress, inclusion of younger children, and an active comparator.

Virtual Reality for Port-a-Cath Access

Virtual Reality for Procedural Distress in Children Undergoing Port-a-Cath Access: A Randomized Controlled Trial

Measured using the Parental Distress Questionnaire (PDQ) immediately following port access and reflective of distress felt related to port-a-cath access. The Parental Distress Questionnaire is a self-reported survey where parents are given 4 emotional adjectives reflecting emotional distress, which are rated on an 11-point numeric scale ranging from 0 = "not at all" to 11 = "extremely" to assess the parent's current distress.

Measured from initial nursing assessment to discharge

Measured from removal of topical anesthetic (if any) to attempted flush of port.

Measured from the procedure nurse using the VR Distraction Satisfaction Questionnaire.

This Questionnaire was developed by Stinson et al. to measure ease of needle insertion, acceptability of VR intervention use, helpfulness of VR intervention, and impact of VR intervention on clinical work flow (nurses' report). It uses a 5-point Likert scale from "unacceptable" to "very acceptable" for nurses.

The Observational Scale of Behavioral Distress - Revised (OSBD-R) will be used. The OSBD-R is an 8-factor, weighted observational scale with total scores ranging between 0 to 23.5 (0 = no distress, 23.5 = maximal distress) , validated in children 1 to 20 years of age for measuring distress associated with medical procedures. This will be measured at the first attempt at port access.

Pain intensity will be measured using the Faces Pain Scale - Revised (FPS-R) immediately following port-a-cath access and reflective of the pain experienced during port access. The Faces Pain Scale is a self-reported measure that uses 6 faces to assess the intensity of children's pain26. It has been validated in children as young as 4 years of age and has a strong positive correlation with the visual analogue scale (r = 0.93 in children 5-12 years of age; r = 0.92 in children 4-12 years of age) and the colour analogue scale (r = 0.84 in children 4-12 years old). It conforms closely to a linear rating scale.

Measured using the Children Fear Scale (CFS) immediately following port-a-cath access and reflective of fear felt during port access. The Children's Fear Scale is a visual scale validated to measure fear in children as young as 5 years old undergoing a painful medical procedure. It was originally validated in children undergoing venipuncture and showed interrater reliability of 0.51, test-retest reliability of 0.76, convergent validity with another self-report measure of fear of 0.73, and moderate discriminant validity of 0.30 with child coping behaviour and 0.41 with child distress behaviour.

Measured using the Child Presence Measure (CPM) immediately after port access and reflective of their experience with the VR intervention. This outcome will only be obtained from the participants in the VR group. It has been shown that immersive virtual environments decreases the subjective experience of pain. The Child Presence Measure is a 12-question survey that measures immersiveness of the VR experience.

These will include but are not limited to:

1. Nausea using the Pediatric Nausea Assessment Tool (PeNAT). The PeNAT is an assessment tool for nausea validated for children undergoing chemotherapy, which uses a standardized script for administration and employs a pictorial scale.
2. Vomiting
3. Dizziness Adverse events will be recorded as those that occur from the initial application of the intervention to 15 minutes post intervention

Lawson Health Research Institute

Peripheral Nervous System Diseases

Neuromuscular Diseases

Antineoplastic Agents

Anti-Dyskinesia Agents

Psychotropic Drugs

Cardiotonic Agents

Vasoconstrictor Agents

Paclitaxel

Albumin-Bound Paclitaxel

Memantine

Venlafaxine Hydrochloride

Antiparkinson Agents

Dopamine

Dopamine Agents

Neurotransmitter Agents

Excitatory Amino Acid Antagonists

Norepinephrine

Serotonin

Serotonin and Noradrenaline Reuptake Inhibitors

Antidepressive Agents

Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)

Venlafaxine

Patients will receive memantine (10 mg) once daily (Morel et al., 2016)

Gehad Sayed Ahmed, MD

This is a double blinded two-arm randomized case-only interventional trial. A total of 60 patients who are to receive Paclitaxel to be included and allocated in two groups. The protocol is to be reviewed by the Research Ethics Committee of Faculty of Medicine Cairo University.

All procedure will be done in Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine.

The first arm (Venlafaxine group) will receive Venlafaxine extended release (37.5 mg) tablets (Zimmerman et al., 2016).

The second arm (Memantine group) will receive memantine 10 mg once daily (Morel et al., 2016)

The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy

Change in average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF). Absolute change in the average daily pain intensity as measured by the Brief Pain Inventory- Short Form (BPI-SF) from baseline to the end of 6 weeks measured by item # 5 of Brief Pain Inventory Score (BPI-SF). The BPI assesses pain at its "worst," "least," "average," and "now" (current pain).

nerve conduction velocity at the end of the study

Cairo University

Mendel AI

Substance Related Disorders

Behaviors and Mental Disorders

Marijuana Abuse

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

This intervention includes different asynchronous pedagogical modalities that allow, among other things, to reactivate the participants' previous knowledge and promote their autonomy in their learning process. These modalities focus on various problems that oncology nurses may encounter about the use of cannabis in oncology (eg, how to tackle the subject, what are the correct times to approach the topic). To this end, various pedagogical modalities that encourage the active participation of nurses are integrated into the training (eg, interactive videos, and quizzes). Scientific articles and links to external resources (official public websites) are also included so that nurses can consult the content at their own pace. Different aspects related to the use of cannabis are addressed in the training (eg, beneficial effects, and potential side effects).

The comparator is composed of an email with basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).

The Cannabis \& Cancer intervention is available on Moodle learning management system in French language. It aims to influence nurses' self-efficacy, attitudes, intentions, and knowledge regarding the safe and efficient use of cannabis by young adults diagnosed with cancer.

Cannabis & Cancer digital educational intervention

Participants will be offered basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).

Standard information regarding cannabis use in oncology

Karine Bilodeau, PhD

José Côté

Billy Vinette, MSN

The purpose of this study is to evaluate the preliminary effects and impacts of a digital educational intervention to support nurses' professional practice regarding safe cannabis use by young adults (18-39 years) diagnosed with cancer.

This online pilot randomized controlled trial with parallel groups is conducted in Quebec (Canada). Moodle learning management system will be used to train nurses working in oncology.

After accepting the conditions and consenting, participants will enroll in the study by providing an email address. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire.

After completing the baseline questionnaire, participants will be randomly assigned by a research assistant to the digital educational intervention (Cannabis \& Cancer) or to a control group (official public websites and scientific articles).

Four weeks after the baseline questionnaire, participants will complete the online questionnaires again.

Cannabis and Cancer, an Online Training for Oncology Nurses

Evaluation of a Digital Educational Intervention Regarding Safe and Efficient Cannabis Use With Young Adults Diagnosed With Cancer: a Pilot Study

The French version of the Continuing Professional Development Reaction (CPD-Reaction) questionnaire (Légaré et al., 2014) will be used. The CPD-Reaction is a 12-item theory-based self-report questionnaire designed to assess the impact of continuing professional development on different clinical practices and can be modified according to the behavior targeted by the continuing professional activity (ie, the Cannabis \& Cancer intervention).

It is scored using a seven-point Likert scale ranging from strongly disagree (1) to strongly agree (7). The total score can range from 3 to 21 for self-efficacy. Higher scores indicate higher levels of self-efficacy. The CPD Reaction has adequate test-retest reliability (ie, weighted kappa coefficient between 0.43-0.53 for self-efficacy). The questionnaire has good internal consistency (Cronbach's alpha = 0.84).

The French version of the Continuing Professional Development Reaction (CPD-Reaction) questionnaire (Légaré et al., 2014) will be used. The CPD-Reaction is a 12-item theory-based self-report questionnaire designed to assess the impact of continuing professional development on different clinical practices and can be modified according to the behavior targeted by the continuing professional activity (ie, the Cannabis \& Cancer intervention).

It is scored using a seven-point Likert scale ranging from strongly disagree (1) to strongly agree (7). The total score can range from 2 to 14 for attitudes. Higher scores indicate more favorable attitudes toward the behavior. The CPD Reaction has adequate test-retest reliability (ie, weighted kappa coefficient between 0.5-0.54 for attitudes). The questionnaire has good internal consistency (Cronbach's alpha = 0.89).

The French version of the Continuing Professional Development Reaction (CPD-Reaction) questionnaire (Légaré et al., 2014) will be used. The CPD-Reaction is a 12-item theory-based self-report questionnaire designed to assess the impact of continuing professional development on different clinical practices and can be modified according to the behavior targeted by the continuing professional activity (ie, the Cannabis \& Cancer intervention).

It is scored using a seven-point Likert scale ranging from strongly disagree (1) to strongly agree (7). The total score can range from 2 to 14 for intention. Higher scores indicate higher intentions to perform the behavior. The CPD Reaction has adequate test-retest reliability (ie, weighted kappa coefficient between 0.54-0.6 for intention). The questionnaire has good internal consistency (Cronbach's alpha = 0.79).

Nurses' knowledge will be assessed using a seven-point Likert scale (ie, 1=strongly disagree and 7=strongly agree) to be developed by the research team based on the educational content presented in the training.

Objective data. This data will be collected automatically when users log into the learning management system.

Subjective engagement (self-reported) will be measured using the validated French version (Fontaine et al., 2020) of the User Engagement Scale - Short Form (UES-SF) (O'Brien et al., 2018). This 12-item instrument serves to measure four dimensions of engagement: 1) aesthetic appeal; 2) focused attention; 3) perceived usability, and 4) reward factor. Possible answers range from strongly disagree (+1) to strongly agree (+5). The possible total score ranges between 12 and 60. The score for each item will be interpreted and the scores for each dimension will be compared to indicate which are rated more highly than others. The French version shows acceptable internal consistency (ie, McDonald's omega coefficients ranging from 0.77-0.89).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)	NCT06354049	Cancer Pain Oncology Pain	Reiki	18 Years - 89 Years	Case Comprehensive Cancer Center
Pituitary Gland Stimulation for Cancer Pain Relief	NCT05230238	Oncology Pain	Pituitary gland...	18 Years -	Leiden University Medical Center
Virtual Reality for Port-a-Cath Access	NCT04931745	Oncology Pain	Virtual reality Tables distract... No or non-techn...	5 Years - 17 Years	Lawson Health Research Institute
Pituitary Gland Stimulation for Cancer Pain Relief	NCT05230238	Oncology Pain	Pituitary gland...	18 Years -	Leiden University Medical Center
The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy	NCT04737967	Oncology Pain Chemotherapy-in...	Venlafaxine Memantine	18 Years -	Mendel AI
Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)	NCT06354049	Cancer Pain Oncology Pain	Reiki	18 Years - 89 Years	Case Comprehensive Cancer Center
Pituitary Gland Stimulation for Cancer Pain Relief	NCT05230238	Oncology Pain	Pituitary gland...	18 Years -	Leiden University Medical Center
Cannabis and Cancer, an Online Training for Oncology Nurses	NCT05663346	Cannabis Use Cannabis Use, U... Nurse's Role Oncology Pain Symptoms and Si...	Cannabis & Canc... Standard inform...	18 Years - 70 Years	Ciusss de L'Est de l'Île de Montréal
The Potential Protective Role of Venlafaxine Versus Memantine in Paclitaxel Induced Peripheral Neuropathy	NCT04737967	Oncology Pain Chemotherapy-in...	Venlafaxine Memantine	18 Years -	Mendel AI

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