Shared meditation involving cancer patients, health professionals and third persons is relevant and improves well-being: IMPLIC pilot study.

BACKGROUND: Alleviating suffering and improving quality of life are universally shared goals. In this context, we implemented a pilot study to assess the feasibility and acceptability of a mindfulness intervention in the form of meditation involving together cancer patients, health professionals, and third persons. METHODS: Two groups of 15 participants equally composed of patients, health professionals and third persons were constituted. A dedicated programme on mindfulness and compassion was constructed, including 12 weekly sessions of 1.5 h and a half-day retreat. Adherence and satisfaction with the programme were evaluated. All participants completed questionnaires on perceived stress, quality of life, mindfulness, empathy, and self-efficacy. Burnout was assessed in health professionals. RESULTS: Shared meditation was feasible as 70% of participants attended ≥ 80% of the 13 meditation sessions. Satisfaction with the programme was high (median satisfaction score: 9.1 out of 10) and all participants expressed positive attitudes towards shared meditation and a benefit on their global quality of life. Participants reported significant improvement in stress (p < 0.001), global quality of life (p = 0.004), self-efficacy (p < 0.001), and mindfulness skills (p < 0.001) from baseline to post-programme. CONCLUSIONS: This study demonstrated the feasibility of a shared dedicated meditation programme in terms of participation and acceptability of participants. The measured benefits observed among participants furthermore justify the interest of a subsequent randomized study aiming to demonstrate the potential added value of shared meditation by promoting bridge-building between cancer patients, health professionals and others. TRIAL REGISTRATION: ClinicalTrials.gov. NCT04410185 . Registered on June 1, 2020.

Ketamine in chronic pain: A Delphi survey.

BACKGROUND: There is no recommendation in Europe for the use of ketamine in patients with chronic pain. The heterogeneity of practice highlights the need to seek the advice of experts in order to establish a national consensus. This Delphi survey aimed to reach a national consensus on the use of ketamine in chronic pain in Pain clinics. METHODS: A collaborative four-round internet-based questionnaire was used. It was created after literature search on ketamine administration in chronic pain and included about 96 items. It discussed utility and advantages, adverse events and deleterious aspects, methods of administration, concomitant treatments and assessment of results. RESULTS: Twenty-eight experts completed all rounds of the survey with a total of 81.3% items reaching a consensual answer. Neuropathic pain represents the first indication to use ketamine, followed, with a good to moderate utility, by other situations (fibromyalgia, complex regional pain syndrome, central neuropathic pain, peripheral neuropathic pain, nociceptive pain, sensitization, opioid withdrawal, palliative care, depression). Experts agreed on the rare occurrence of adverse events. Concerning routes of administration, intravenous infusion with doses of 0.5-0.9 mg/kg/d for 4 days of treatment is preferred. Place of care is hospital, as in- or out-patient, with a quarterly administration of ketamine. Finally, ketamine effectiveness is assessed 1 month after infusion, and experts encourage combination with non-pharmacological treatment. CONCLUSIONS: This Delphi survey established a consensus of pain specialists on the use of ketamine in refractory chronic pain, thus providing a basis for future comparative trials. SIGNIFICANCE: This Delphi survey in chronic pain reached agreement on four main aspects: (1) Priority to treat neuropathic pain with evaluation of effectiveness at 1 month; (2) No deleterious effects in the majority of listed diseases/situations with the absence or <3% of suggested adverse events; (3) 0.5-0.9 mg/kg/d IV infusion; (4) Combination with non-pharmacological treatment.

Cancer Pain and Patient Education: Strategy, Implementation, Difficulties and Opportunities of EFFADOL, a Regional Collaborative Programme.

While pain remains a burden for many cancer patients, their active involvement in dealing with it through therapeutic patient education (TPE) has proved effective in overcoming hurdles to pain management. This article describes how a regional TPE programme devoted to cancer pain was set up, as well as the difficulties and opportunities encountered during its implementation. Ten nurse-doctor pairs from the chronic pain units of Lower Normandy, after being trained in TPE, designed and built the EFFADOL (Ensemble Faire Face A la DOuLeur [Cope together with pain]) programme. They collaboratively developed the pedagogical, evaluation and communication tools used in the programme. After the educational diagnosis step, patients are able to follow three sessions in order to acquire the following skills: (1) understanding the different types of pain, (2) understanding pain treatments and their adverse reactions and (3) optimally managing pain on a daily basis. Patients can ask a relative to join the sessions and can choose their preferred modality (individual and/or collective sessions). Programme implementation and the importance of communicating with oncologists and independent health professionals are discussed. The programme, which is available to patients close to home, meets their needs as previously assessed through a regional prospective survey. Difficulties to include patients and opportunities to address them are identified. The programme's limitations mainly concern its organization, structure and communication issues. The main challenge remains the overhaul of care practices and the role of the caregiver to allow patient autonomy.

Meditation involving people with cancer, medical staff and witnesses: a pilot study exploring improvement in wellness and connectedness.

INTRODUCTION: Mindfulness meditation is likely to promote better management of stress, pain and negative emotions. We propose to address the benefit of meditation in an open setting associating people with cancer (target population), medical staff and witnesses (neither patient nor medical staff). This study aims (1) to evaluate the effects of meditation on wellness improvement and (2) to identify criteria and modalities for a subsequent randomised study. METHODS AND ANALYSIS: We propose a longitudinal pilot study consisting of a non-randomised experimental preintervention/postintervention survey. The intervention consists in delivering a meditation programme (12 weekly meditation sessions of 1.5 hours each), specifically adapted to our target population and addressing our research hypothesis in an open setting involving people with cancer, medical staff and witnesses (equally distributed in two groups of 15 participants). The main objective is to evaluate participants' adherence to the programme. The effects of meditation will be evaluated on stress, quality of life, feeling of personal effectiveness, on the development of mindfulness and empathy, and on satisfaction and perception of a change in quality of life. We will also measure the putative added value of 'meditating together'. This study is expected to allow validating the evaluation tools and refining the modalities of the workshops. We expect to demonstrate the evolution that this meditation-based intervention induces in the participants. We aim to promote bridge-building, between patients, medical staff but also others. In this way, one's own suffering may be understood in the light of others' suffering, thereby promoting the sense of otherness and giving insights into 'living better with'. This exploratory study will investigate the relevance of this hypothesis, which could then be explored by a randomised study. ETHICS AND DISSEMINATION: The protocol was approved by the local ethics committee (Comité de Protection des Personnes Est II). Trial findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04410185.

Safety and efficacy of an equimolar mixture of oxygen and nitrous oxide: a randomized controlled trial in patients with peripheral neuropathic pain.

ABSTRACT: Nitrous oxide (N2O) is an odorless and colorless gas routinely used as an adjuvant of anesthesia and for short-duration analgesia in various clinical settings mostly in the form of an N2O/O2 50%-50% equimolar mixture (EMONO). Experimental studies have suggested that EMONO could also induce long-lasting analgesic effects related to the blockade of N-methyl-D-aspartate receptors. We designed the first international multicenter proof of concept randomized, placebo-controlled study to assess the efficacy and safety of a 1-hour administration of EMONO or placebo (medical air) on 3 consecutive days up to 1 month after the last administration in patients with chronic peripheral neuropathic pain. A total of 240 patients were recruited in 22 centers in France and Germany and randomly assigned to 1 study group (120 per group). Average pain intensity (primary outcome), neuropathic pain characteristics (Neuropathic Pain Symptom Inventory), Patient Global Impression of Change, anxiety, depression, and quality of life were systematically assessed before and after treatment. The changes in average pain intensity between baseline and 7 days after the last administration were not significantly different between the 2 groups. However, evoked pain intensity (predefined secondary endpoint) and Patient Global Impression of Change (exploratory endpoint) were significantly improved in the EMONO group, and these effects were maintained up to 4 weeks after the last treatment administration. Mostly transient side effects were reported during the treatment administration. These encouraging results provide a basis for further investigation of the long-term analgesic effects of EMONO in patients with neuropathic pain.

A supportive care dedicated hospitalization ward in comprehensive cancer center.

INTRODUCTION: Supportive care development has created new needs in patients' care pathway. In order to anticipate, evaluate, and take care of patients' needs, a supportive care dedicated hospitalization ward was created in late 2016 in our comprehensive cancer center, including 15 beds (11 for week care and 4 for day care). We aimed to assess the activity of this supportive care ward in 2018. METHODS: Data were extracted from weekly activity reports of supportive care ward and retrospectively analyzed. Those reports are automatically generated from hospitalization scheduling software. RESULTS: In week care ward, 627 stays were recorded. Occupancy rate was 88%. Mean stay duration was 3.01 days. Main indications for week stay were pain evaluation and management (47.4%) and nutritional management (31.7%). In day care ward, 1191 stays were registered. Turnover rate was 1.18 patients/bed/day. Main indications for day stay were pain management (41.6%) and comprehensive geriatric assessment in oncology (22.8%). CONCLUSION: The 2018 supportive care ward evaluation showed its viability in comprehensive cancer center. The main activity was based on pain and nutritional management.

Effectiveness of a therapeutic patient education program in improving cancer pain management: EFFADOL, a stepped-wedge randomised controlled trial.

BACKGROUND: Despite numerous guidelines, nearly one of two patients with cancer pain remains undertreated, thereby affecting their quality of life. Active patient involvement through Therapeutic Patient Education (TPE) is considered as a relevant strategy to overcoming hurdles in pain management. The aim of the EFFADOL study is to assess the effectiveness of a TPE program in improving cancer pain management. METHODS/DESIGN: The EFFADOL study is a stepped-wedge randomised controlled trial. A total of 260 cancer patients with unbalanced background pain will be randomised over the institutional level, i.e. stepped-wedge cluster design. Six clusters will be formed, one at the regional level of "Basse-Normandie" for patients receiving the educational approach by health providers already trained to TPE. Then, five additional centers will be gradually included at the national level, making it possible to compare the "conventional" management of pain (before medical staff training to TPE) with the educational approach (after being trained). The main study parameter is pain interference on daily life assessed with the self-administrated and validated Brief Pain Inventory questionnaire. Secondary objectives comprised the evaluation of patients' adherence to pain education program, the description of pain intensity, pain relief, analgesic adherence and pain emotional impact. Educational dimension of the program will be evaluated through the patients' acquisition of knowledge and skills about their pain and treatment as well as their self-efficacy to participate actively in pain management. The patient's feeling of pain changes will be measured. Finally, the satisfaction of participants and educators will be reported. We hypothetise active involvement of patients in TPE will lead to an improved pain management compared to standard care. DISCUSSION: Analyzing the impact of a TPE program in cancer pain patients will improve their pain management and quality of life. We expect that the dissemination of our project educational approach through the French territory will be accompanied by long term change in clinical practices with mutual benefit to patients and caregiver-educators. TRIAL REGISTRATION: NCT03297723 , registered: 09/28/2017. Protocol version: Version n°1.1 dated from 2016/09/08.

[Drug management of cancer-related peripheral neuropathic pain: A systematic review of the literature]. / Prise en charge médicamenteuse des douleurs neuropathiques périphériques liées au cancer : une revue systématique de la littérature.

The objective of the present systematic literature review was to provide an update on medical treatment of neuropathic pain in cancer patients. The number of cancer patients is steadily increasing. Pain is frequent in cancer patients. Few studies have focused on medical treatment of pain, and especially of neuropathic pain, in current or former cancer patients. The present systematic review of all studies published between December 2012 and August 2018 was intended to estimate the scale of this lack. In all, 27 articles were identified on a systematic PubMed search and from the authors' personal knowledge, confirming that scant data have been published. The heterogeneity of cancer patients, of cancer, and of pain go some way toward explaining this scarcity. Guidelines, founded mainly on results from non-cancer patients, recommend tricyclic antidepressants and antiepileptic drugs; local treatments have the advantage of good systemic tolerance. Larger-scale studies taking account of the etiology of neuropathic pain, its characteristics (strictly neuropathic or mixed) and patient characteristics (awaiting treatment, under treatment, recent or non-recent survivor, or in terminal phase) along the care pathway are needed to improve knowledge. The results of the present literature analysis can help future research.

[Elaboration and evaluation of a therapeutic education program in cancer pain management]. / Construction et évaluation d'un programme d'éducation thérapeutique du patient dans le domaine de la douleur liée au cancer.

Pain, one of the most feared symptoms for patients with cancer, remains insufficiently alleviated and impairs quality of life. Therapeutic patient education (TPE) is a relevant approach to this problem while allowing patients to develop skills to better manage their pain. In the "Basse-Normandie" French region, the management of pain relies on two organized networks, thus allowing proximity and accessibility for all concerned. In this context, our team has begun a broad five-step research program that is part of a regional health policy: (1) training in TPE of 10 doctor/nurse pairs; (2) identification of educational expectations of patients and their relatives in the field of cancer pain; (3) design and optimization of a TPE program dedicated to cancer pain; (4) regional pilot study aiming to assess the feasibility, quality and transferability of the program; (5) evaluation of the TPE program by interventional comparative randomization at the national level. This article aims to present the program which originality and strengths are based on collaborative work between health stakeholders. Objectives, methodology and expected results of the research phase (stages 2, 4, 5) are notably developed. The main expected outcomes are to prove the effectiveness of the program in improving the knowledge and skills of patients in the field of pain cancer in order to promote their adherence to treatment and, consequently, to enable them to better manage it. The long-term objective is to disseminate the educational approach by modifying practices that provide a mutual benefit for caregivers and patients.

[Opioid switch and change of route of administration in cancer patients treated by morphine]. / La morphine dans le cadre du changement d'opioïdes ou de voie d'administration, chez l'adulte avec une douleur due au cancer.

This paper reviewed the 2002 guidelines established by the National Federation of Cancer Centres. A group of experts nominated by the 3 French Societies involved in the treatment of cancer pain (AFSOS, SFAP, SFETD), established new guidelines ratios for morphine switching and/or changing of route of administration, in patients for whom either pain was not adequatly managed or adverse effects were unbearable. After a rapid reminder of the pharmacokinetics and metabolism properties of morphine, experts explained why the theory of opioid rotation (oxycodone, hydromorphone, fentanyl, methadone, tapentadol) using fixed equianalgesic ratios is not any more appropriate for a secure clinical practice. In the light of recent publications enhancing our knowledge on the efficacy of new drug switching ratios and for changing the route of administration of morphine, the group of experts recommended to use reconsidered switching ratios favoring security upon efficacy, to minimize overdosing and adverse effects. Consequently, after the new conversion ratio (using slow release opioids) was applied, a second titration should be done by means of normal release rescue formulations for breakthrough pain episodes. A smartphone App. OpioConvert® will be available for rapid and secure dose conversions.

Therapeutic Patient Education in Cancer Pain Management: from Practice to Research: Proposals and Strategy of the French EFFADOL Program.

In the field of cancer pain, therapeutic patient education (TPE) allows patients to develop skills to better manage their pain. In the Lower Normandy region of France, the management of pain is based on networking, thus allowing proximity and accessibility for all concerned. We have thus designed and initiated a broad five-stage research program that includes the following: (1) training for caregivers in TPE; (2) identifying the educational expectations of patients and their relatives with regard to cancer pain; (3) the design of a TPE program; (4) the evaluation of its quality; and (5) the evaluation of its effectiveness by comparative randomization. This article presents this approach and more particularly the research phases (stages 2, 4, 5) for which the objectives, the methodology, and the expected results are justified. Among the key points, particular attention is paid to the evaluation of the educational dimension that provides patients with self-efficacy to participate actively in the management of their pain, their perception of changes in relation to it and its impact. The choice of a specific assessment criterion (subscale 9 of the Brief Pain Inventory) and of the step-wedge design are thus argued. This approach, which is based on a partnership between health care professionals and researchers, aims to demonstrate the benefits provided by TPE to patients in order to enable them to better manage their pain on a daily basis.

Localized neuropathic pain: an expert consensus on local treatments.

BACKGROUND: Pain localization is one of the hallmarks for the choice of first-line treatment in neuropathic pain. This literature review has been conducted to provide an overview of the current knowledge regarding the etiology and pathophysiology of localized neuropathic pain (LNP), its assessment and the existing topical pharmacological treatments. MATERIALS AND METHODS: Literature review was performed using Medline from 2010 to December 2016, and all studies involving LNP and treatments were examined. A multidisciplinary expert panel of five pain specialists in this article reports a consensus on topical approaches that may be recommended to alleviate LNP and on their advantages in clinical practice. RESULTS: Successive international recommendations have included topical 5% lidocaine and 8% capsaicin for LNP treatment. The expert panel considers that these compounds can be a first-line treatment for LNP, especially in elderly patients and patients with comorbidities and polypharmacy. Regulatory LNP indications should cover the whole range of LNP and not be restricted to specific etiologies or sites. Precautions for the use of plasters must be followed cautiously. CONCLUSION: Although there is a real need for more randomized controlled trials for both drugs, publications clearly demonstrate excellent risk/benefit ratios, safety, tolerance and continued efficacy throughout long-term treatment. A major advantage of both plasters is that they have proven efficacy and may reduce the risk of adverse events such as cognitive impairment, confusion, somnolence, dizziness and constipation that are often associated with systemic neuropathic pain treatment and reduce the quality of life. Topical modalities also may be used in combination with other drugs and analgesics with limited drug-drug interactions.

Therapeutic Education in Improving Cancer Pain Management: A Synthesis of Available Studies.

This literature review aims to synthesize available studies and to update findings in order to obtain a current, comprehensive estimate of the benefits of pain education. Forty-four original articles obtained from the PubMed database were analyzed to investigate which protocols could be most effective in improving pain management. Recent studies indicate a growing interest in evaluating patients' skills and attitudes; these include satisfaction with cancer pain treatment, patient-reported improvement, and patient participation-all of which could be dependable benchmarks for evaluating the effectiveness of educational programs. Besides pain measurement, recent studies advance support for the importance of assessing newly developed outcome criteria. In this sense, patients' active participation and decision making in their pain management are probably the most relevant goals of pain education.

5% Lidocaine Medicated Plaster for the Treatment of Postherpetic Neuralgia: A Review of the Clinical Safety and Tolerability.

Postherpetic neuralgia (PHN) is a common, very painful, and often long-lasting complication of herpes zoster which is frequently underdiagnosed and undertreated. It mainly affects the elderly, many of whom are already treated for comorbidities with a variety of systemic medications and are thus at high risk of drug-drug interactions. An efficacious and safe treatment with a low interaction potential is therefore of high importance. This review focuses on the safety and tolerability of the 5% lidocaine medicated plaster, a topical analgesic indicated for the treatment of PHN. The available literature (up to June 2014) was searched for publications containing safety data regarding the use of the 5% lidocaine medicated plaster in PHN treatment; unpublished clinical safety data were also included in this review. The 5% lidocaine medicated plaster demonstrated good short- and long-term tolerability with low systemic uptake (3 ± 2%) and minimal risk for systemic adverse drug reactions (ADRs). ADRs related to topical lidocaine treatment were mainly application site reactions of mild to moderate intensity. The treatment discontinuation rate was generally below 5% of patients. In one trial, the 5% lidocaine medicated plaster was better tolerated than systemic treatment with pregabalin. The 5% lidocaine medicated plaster provides a safe alternative to systemic medications for PHN treatment, including long-term pain treatment.

Treatment of neuropathic pain with 5% lidocaine-medicated plaster: Five years of clinical experience.

BACKGROUND: Neuropathic pain is often severe and adversely affects patients' quality of life. OBJECTIVE: To perform a retrospective, observational study investigating the efficacy and safety of treating refractory chronic neuropathic pain with 5% lidocaine-medicated plaster, in patients attending pain centres. METHODS: Medical records from 467 patients treated with 5% lidocaine-medicated plaster were evaluated for efficacy (maximum and minimum pain intensities and coanalgesic consumption) and adverse events. Data from an initial assessment and at least one follow-up visit had to be available, and separate analyses were conducted for the general population and the subpopulation older than 70 years of age. RESULTS: Of the patients enrolled, 25.0% were older than 70 years of age. While 20.6% had postherpetic neuralgia, 76.3% had other types of peripheral pain. Approximately 78.1% of cases of peripheral neuropathic pain followed surgery, and 23% were post-traumatic pain. The time from onset to referral was more than one year in two- thirds of cases. All patients experienced pain of at least moderate severity (mean [± SD] 11-point numerical rating scale score 5.2 ± 2.4 to 8.2 ± 1.6). Treatment with 5% lidocaine-medicated plaster reduced pain intensity by more than 50% in 45.5% of patients, and by at least 30% in 82.2%. Of note, the consumption of analgesics and coanalgesics was significantly reduced. Results were similar in both the general population and the subpopulation older than 70 years of age, at high risk and often receiving multiple medications. CONCLUSIONS: Treatment of refractory neuropathic pain with 5% lidocaine-medicated plaster clearly demonstrated efficacy and an excellent safety profile in patients with refractory neuropathic pain.