A randomised study to evaluate the potential added value of shared meditation involving people with cancer, health professionals and third persons compared to meditation conducted with patients only: design of the Implic-2 protocol

Abstract

Background

In oncology, the suffering of patients and the burnout of health professionals are key issues. Mindfulness meditation is a holistic approach that can help to improve well-being. While numerous studies have shown the benefits of meditation for both patients and health professionals, the added value of offering shared meditation to groups of patients, health professionals and third persons has not been assessed. Beyond strengthening the relationship between carers and patients, opening up meditation sessions to third parties (neither carers nor patients) enables patients to escape the stigma of their illness. We previously conducted a pilot study that validated the feasibility and the relevance of shared meditation with a specifically designed programme.

Methods/Design

IMPLIC-2 is a two-arm randomised study designed to assess the added value of this meditation programme (optimised following the pilot study), particularly for cancer patients (our target population). People motivated to follow the programme, without previous regular practice of meditation and able to participate in the sessions are eligible. The study will include 96 participants: 16 health professionals, 16 third persons and 64 patients. The latter will be randomized in two arms: the experimental arm (“Shared” meditation) consisting of 4 mixed groups of 8 patients, 4 health professionals and 4 third parties, and the control arm (“Patient” meditation) consisting of 2 groups of 16 patients. Validated questionnaires will be used to measure the effects of the programme, notably in terms of quality of life, perceived stress, feelings of self-efficacy, qualities of mindfulness and self-compassion, and carers’ burn-out. Participants' perception of a change in their quality of life and satisfaction will be measured at the end of the programme. A complementary qualitative focus-group approach will be used to optimise implementation of the programme beyond the study.

Discussion

The well-being of oncology patients would be improved. Dealing with overworked carers would have a beneficial impact on the way they interact with patients. In addition, encounters between the three types of population will allow otherness to be viewed differently and alleviate suffering by promoting collective humanity.

Trial Registration

NCT06041607, registered: 09/18/2023.

Protocol version

Version n°1.2 dated from 08/29/2023.

Background

People with cancer experience a large number of troublesome symptoms that may impact their quality of life [1], impaired in 44% of patients 5 years after cancer diagnosis [2]. Despite therapeutic progress, pain still affects 55% of patients [3], while 20% and 10% suffer from depression and anxiety respectively, which is much higher than in the general population [4]. Medical staff also suffer and are increasingly threatened by burnout, particularly in oncology [3] where health professionals have to take life and death decisions daily [5, 6].

In response to the suffering of both patients and medical staff, integrative medicine, which focuses on complementary therapeutic approaches, the holistic consideration of subjects and their autonomy is a relevant approach [7]. Among the complementary therapies, mindfulness meditation [MM] is a mind–body intervention designed to alleviate suffering and stress-related symptoms and to promote well-being. In the 1970s, Kabat-Zinn defined mindfulness as non-judgmental attention to experiences of the present moment, including thoughts, emotions, and bodily sensations [8]. He designed a protocoled programme accessible to all called MBSR (Mindfulness-Based Stress Reduction), which was initially developed for chronic pain patients [9].

In oncology, three recent meta-analyses evaluating mindfulness-based interventions underline its beneficial effects on patients in terms of improving psychological well-being, particularly by reducing stress, anxiety and depression [10,11,12]. Among health professionals, meta-analyses show that MM reduces suffering at work and improves carers’ well-being [13]. Scheepers’ systematic review showed overall beneficial effects of this type of intervention on physicians’ well-being and performance [14]. A recent review sought to assess the impact of mindfulness on improving patient-caregiver interactions [15], and Dobkin showed that the positive effects of MM on clinicians’ well-being are reflected in the quality of communication with their patients, who feel better understood [16].

As a response to suffering through a process of inner transformation, meditation can form a bridge between the patient (who wishes to be more involved in his or her illness) and the health professional (who sometimes needs care) [17]. In fact, vulnerability concerns more people than those who experience illness: it is a feeling shared by everyone, an inherent part of our common humanity [18]. While all human beings are in the same boat, it is important to transform our relationship with ourselves by becoming aware of our interdependence. Recognition of our common humanity has great healing power [19]. The idea that we can fully separate our own wellbeing from those of others is a fallacy [19]. Care and subjects are inseparable, and reciprocal subjective recognition between patients and carers is decisive [18]. Particularly when it is the subject of care, vulnerability can be “empowering”, giving people the physical and psychological capacity to overcome their illness [18]. One-off experiments are sometimes offered simultaneously to patients and health professionals [17, 20]. For example, mindfulness sessions have been conducted at the Stress Clinic created in Massachusetts by Kabat-Zinn, where patients and medical staff come together to meditate [17], aiming at building bridges between health professionals and patients. However, as these sessions take place outside the framework of research, their effectiveness remains to be demonstrated.

We decided to offer meditation to cancer patients (our target population) in the form of joint group workshops directly involving healthcare professionals and patients. Apart from the opportunity to strengthen the relationship between carers and patients, participation in these workshops of subjects who are neither carers nor oncology patients (third parties) could encourage openness to others and, in particular, enable patients to break away from the stigmatising framework of their illness. In addition to the individual benefits that meditation can bring, we therefore decided to evaluate the additional benefits that shared meditation provides, particularly to our target population.

The project meets two objectives: (1) from a clinical point of view, patients need comprehensive care that complements their medical treatment, in a setting that breaks down the barriers between patients and hospitals, and (2) we need to evaluate our approach robustly in order to validate its effectiveness and, where appropriate, promote its dissemination.

In routine practice, establishments that provide care offer too few activities that consider patients as unique whole beings, encompassing their social, psychological, spiritual and community dimensions as much as their biological and bodily ones. MM potentially opens up the field of care. It provides accessible mental training, a 'way of being', to help patients cope better with illness and alleviate many of their symptoms. In general, it can offer solutions to the common problems of psychological suffering and stress linked to our lifestyles, allowing individuals to respond differently and more appropriately to their troubles.

Our literature review showed that complementary alternative medicines, including MM, are still insufficiently evaluated, so their level of scientific proof is low [21]. Some reports stress the importance of considering the potentially adverse effects such as fear and anxiety that they may generate [22, 23]. Evidence-based research is therefore required to clarify these issues.

Firstly, we tested the relevance of our hypothesis in a pilot study [24]. Patients were encouraged to reflect on whether contact with their healthcare professional was possible outside the hospital setting; health professionals experiencing distress were invited to meet patients outside working hours; and third parties found themselves confronted with the illness and tribulations of others.

This pilot study [24] conducted on 10 patients, 10 health professionals and 10 third parties helped to validate the acceptability and feasibility of shared meditation. Overall, the participants adhered to the programme (70% of them attended more than 80% of the 13 planned sessions) and were very satisfied with it (median satisfaction score: 9.1 out of 10). Thanks to this preliminary stage, we were also able to refine the details of the programme (eligibility criteria, content and duration of the programme, assessment tools, etc.) with a view to conducting the present study. Despite the small number of participants, the evaluations before and after the programme revealed significant beneficial effects of MM, particularly in terms of improving quality of life, reducing perceived stress, increasing feelings of personal efficacy, and developing qualities of mindfulness [25]. A complementary qualitative study carried out with 22 of the participants using focus groups for each type of population enabled us to explore in more detail their perception of shared meditation and confirmed its value [26].

Objectives

As a continuation of our feasibility study, this original randomised study will investigate the putative added value of MM as part as shared meditation and the effects of meditation on the well-being of patients, health professionals and third persons. The meditation programme will be conducted with two groups: one composed of patients, health professionals and third persons and the other comprised solely of patients. The expected added value will be measured by the feeling of self-efficacy, which is considered a psychosocial skill by psychologists.

The secondary objectives are to assess the effects of shared meditation on each of the three populations but particularly the patients. Evaluation will be carried out quantitatively by means of standardized questionnaires administered before and after the programme and capturing feelings of self-efficacy, perceived stress, the development of mindfulness and self-compassion, and quality of life. In addition, burnout will be assessed in health professionals. Participants' satisfaction, adherence to the programme, and the perception of a change in their overall quality of life will be assessed after the meditation programme. The putative benefits of ‘meditating together’ will be measured a priori in all participants and a posteriori in the experimental arm. In addition, a qualitative analysis will be performed using focus groups at the end of the programme for each category of participants in the experimental arm. Consequently, we will be to improve the meditation programme with a view to its wider dissemination.

Methods/design

Clinical trial design

This study is a two-arm single-centre randomised controlled trial targeting cancer patients (https://classic.clinicaltrials.gov/ct2/show/NCT06041607). The IMPLIC-2 protocol and this manuscript have been written in accordance with standard protocol items, namely recommendations for interventional trials (SPIRIT). Meditation will take place in two ways: (1) for the experimental arm, in the form of joint group workshops involving health professionals, patients, and third persons (neither patients nor health professionals) motivated to take part; (2) in the form of workshops for patients only for the control arm. The meditation programme will be identical for both arms.

This randomised study will be conducted on 96 participants in 6 groups of 16 participants. Only patients will be allocated to one of two meditation modalities (experimental or control arm) by randomisation (1:1 randomisation), stratified by age (< 55 years vs. ≥ 55 years) and gender. For the experimental shared meditation arm: 4 mixed groups of 16 participants each (involving 8 patients, 4 health professionals, and 4 third persons) will be constituted for whom the programme will be delivered outside the hospital (Pôle des Formations et de Recherche en Santé of Caen University, France). For the control patient meditation arm, two groups of 16 patients will be formed and the programme will be delivered at the hospital (Comprehensive Cancer Centre François Baclesse).

Study participants

Eligibility criteria are detailed in Table 1. The main parameter for inclusion is curiosity about meditation and motivation to be part of a study on it. Those recruited should have no current or previous experience of regular or intensive meditation or comparable practice [27]. For people with cancer, their health status must allow them to attend the sessions. Concerning the medical staff, any medical and/or paramedical staff involved in the management of people with cancer (doctors, nurses, nursing assistants, radiotherapy/radiology operatives…) will be eligible. As for third persons, those not belonging to the above-mentioned categories will be eligible. They can be relatives of the patient or non-medical staff at Centre François Baclesse. They can also be people from outside the Centre provided that they are not health professionals. The eligibility of late-stage cancer disease with a life-threatening condition or significant vulnerability such as alcohol or drug dependence and severe depression will be assessed on a case-by-case basis. In this regard, the participant's degree of commitment to the project will be a determining criterion. Information about the study through flyers will be displayed in the centre (hospital meeting and information area) and outside, indicating the contact details. Interested participants will then be phoned by the clinical research nurse in charge of the study to check their eligibility and give them the printed study information note. All participants will provide written informed consent before any study procedure.

Table 1 Eligibility criteria

Participant inclusion and randomisation of patients

Once the participant's agreement has been obtained by signing the information note and checking the eligibility criteria, inclusion will take place before the meditation programme begins and will be recorded on the dedicated software via an internet portal. For patients, a stratified randomisation based on age and sex will be carried out to determine the type of workshop designated: "shared" or "patient" meditation. An identification number will be allocated to each participant and will be used throughout the study.

Mindfulness intervention

This programme designed and delivered by an expert in meditation for the pilot study was optimised following analysis of satisfaction questionnaires and focus group findings from the pioneering study [25, 26]. It was definitively validated by two patients (pilot study patient and patient-partner) before the study began.

This revised programme (Fig. 1) consists of 12 weekly sessions (2 h) on MM. A 2-week break will be proposed after the eighth session to allow participants to experiment meditation in autonomy. Three monthly follow-up sessions (2 h) in remote format (videoconference) have also been added in response to comments made by participants during the pioneering study, to provide participants with gradual support so that they can become autonomous in their practice and to make it sustainable. Finally, two half-day retreats (3 h) in silence will also be offered. The first retreat will take place between the ninth and tenth weekly sessions, in an intermediate week, so as not to add to the weekly programme and to be able to keep the same day slots. The second retreat will take place at the end of the programme (after the three monthly follow-up sessions) and will be associated with a debriefing with the researchers. The aim of these retreats is to enable participants to explore meditation in greater depth in a different format (meditation on taste over a shared meal, meditative walking, etc.). Finally, a focus group session will be organised in the days following the end of the programme.

Fig. 1

Study design

The themes covered during these meditations will relate to mindfulness, and in particular will explore breathing, sensations, sounds, and body scanning. Themes such as interdependence, benevolence, compassion, and wisdom will also be addressed. Participants will be asked to carry out daily meditation exercises at home. To guide them in this practice, written and audio materials designed by the teacher will accompany participants outside the sessions. Individual follow-up will be offered, if necessary, by phone or videoconference in order to resolve any issues raised during the sessions that cannot be dealt with within the group.

Study flow chart

The assessments carried out and their timing are presented in Table 2. Quantitative evaluations will be performed by means of questionnaires before and after the programme (after 12 weekly sessions and then after the three additional monthly sessions). They will focus on quality of life, perceived change in overall quality of life after the programme, perceived stress and feelings of self-efficacy. The quality of mindfulness and self-compassion will also be assessed, as will burnout among health professionals.

Table 2 Summary of assessments and timing

Participants' opinions on various aspects of meditating together at the start of the programme will also be collected to find out what they think about it a priori (in terms of apprehension, benefits, difficulties and experience, depending on their status and in relation to other categories of participants) and a posteriori at the end of the programme (after the 12 weekly sessions, in the experimental arm) to obtain their views on how they experienced it and how their conception of it has (possibly) changed. In addition, participants will give their opinion of shared meditation by rating it on a scale. After 12 weekly sessions, participants' adherence to and satisfaction with the programme will be assessed. A qualitative analysis using focus groups will complete the assessment.

Tools for evaluation

Assessment of participants' quality of life, stress and sense of self-efficacy

Quality of life will be assessed globally using a proven visual analogue scale (VAS) [28]. The Perceived Stressed Scale (PSS) is a validated 10-item questionnaire adapted from Cohen and colleagues [29]. It provides a quick and easy way of measuring the extent to which life situations are generally perceived as threatening, i.e. unpredictable, uncontrollable, and distressing. Participants’ perception of a change in their overall quality of life will be measured at the end of the programme. In the health professionals population, burnout will be assessed using the Maslach Burnout Inventory (MBI) [30] translated into French by Alain and Gévry [31]. This explores feelings of emotional exhaustion, dehumanisation, and personal fulfilment at work. The development of psychosocial skills will be assessed using the Generalized Self Efficacy Scale (GSES) [32], validated in French [33] which is commonly used in positive psychology.

Assessing the qualities of mindfulness and self-compassion

Various tools can be used to assess the qualities of mindfulness [34]. The questionnaire used in this project is the Freiburg Mindfulness Inventory (FMI) developed in 2001 [35], which provides a self-assessment of a subject's aptitude for 'mindfulness' in daily life. Its brief 14-item version [36] has been validated in French [37]. During the pilot study, we used the Interpersonal Reactivity Index [38] to assess empathy. However, the relevance of a self-reported measure of empathy was questioned [25]. Assessing self-compassion might prove more relevant, as studies have shown that a change in self-compassion significantly predicts a change in most other outcomes, supporting the idea that an increase in self-compassion might be the main mechanism of the effectiveness of a programme including this dimension [19]. The questionnaire chosen was the Neff Self-Compassion scale (SCS) [39] validated in French [40]. This scale includes six sub-dimensions, one of which is dedicated to the sense of common humanity, the main objective of our project.

Assessing the potential added value of meditating together

In addition, we will use non-validated questionnaires specifically designed for this study. In particular, this concerns the evaluation of the putative benefit of meditating together, an issue likely to provide added value to our target population. However, although this issue seems relevant in terms of the integrative approach in clinical psychology, it has not been developed in clinical practice and therefore has not been evaluated. Quantitative evaluation will be carried out globally using an Osgood semantic differentiation scale. Participants will be asked to rate their opinion on how they assess the possible benefits of meditating together between two antonymous poles: “extremely beneficial” and “extremely harmful”. Various aspects of this issue, clarified through the focus groups conducted in the pilot study, will be assessed using Likert scales to refine the overall response, depending on the participant's status (patient, health professionals, and third persons). These scales will concern participants' a priori feelings about meditating together in terms of apprehension, advantages, difficulties and experience, according to their status and in relation to the other categories of participants. For participants in the experimental arm, the benefit of meditating together will be measured at the end of the 12 weekly meditation sessions using an in-house questionnaire similar to the one proposed at baseline, but allowing the participants' experience to be included.

Complementary qualitative evaluation using focus groups

In addition to the analysis using questionnaires, focus groups will be organised for qualitative exploration at the end of the programme. Participants' opinions on the proposal to meditate together will be gathered during a 2-h session using the focus group method [41] conducted in the experimental arm. Thanks to the dynamics of the group, this approach will make it possible to validate and clarify the formulation of the main hypotheses to be explored in our in-depth study, and even to encourage the emergence of relevant issues raised by the participants. This will be an opportunity to compare participants’ opinions on the practical details of the meditation programme (organisation of sessions, etc.), its content, its effects, and areas for improvement, in addition to the closed questions in the satisfaction questionnaire. Avenues for improving the programme with a view to its future dissemination as part of supportive care within the facility, but also outside the local context, will also be explored.

The focus groups will be conducted for each category of participants in the experimental arm separately, so as to guarantee the homogeneity of each group and ensure a fruitful and fair discussion (with groups of a maximum size of 16 persons, i.e. two groups of patients (maximum), one group of third persons and one group of health professionals). The focus group sessions will be based on a pre-selected set of six open questions relating to participants’ experience of (1) the personal added value provided by the shared meditation programme, (2) ways of improving the programme with a view to future dissemination. The sessions will be led by an external moderator specialised in ethical issues. Focus group sessions will last around two hours for each group in order to obtain complete answers to the questions and generate enough information to achieve data saturation.

Evaluation of participant satisfaction

Participant satisfaction will be assessed at the end of the 12 weekly sessions of the meditation programme. The dimensions that will be measured are the planning of the training, the content of the programme and the teaching methods used, as well as the quality of relations with the trainer and exchanges with/among the participants.

Primary and secondary endpoints

In line with the primary objective, the primary endpoint is the change in patients' sense of self-efficacy score on the GSES self-efficacy scale (score between 10 and 40) [33] measured at the end of the meditation programme (including 12 weekly sessions and a half-day retreat conducted between week 9 and week 10), compared with the measurement at inclusion. The added value will be assessed through the difference in the sense of self-efficacy measured in patients before and after the meditation programme, between the two meditation modalities. The GSES was chosen for its relevance to our research hypothesis, as it enables psycho-social skills to be assessed (ability to respond effectively to the demands and challenges of everyday life).

In line with the secondary objectives, the secondary endpoints used in our study are the scores obtained on validated questionnaires concerning overall quality of life, perception of a change in their overall quality of life (VAS), perceived stress, mindfulness qualities, self-compassion measured in all participants as well as the score obtained on the burnout questionnaire (for health professionals).

Other secondary criteria are the evaluation of the benefits of “meditating together” (scale between “extremely harmful” and “extremely beneficial”), the adherence and satisfaction of participants and the results of the focus group analysis at the end of the programme (experimental arm).

Statistical considerations

Sample size calculation

The added value of shared meditation versus patient-only meditation will be considered relevant if there is an additional post/pre-intervention improvement of at least 5% (1.5 points) on the GSES (score between 10 and 40). This change of more than 5% in the mean score has been described as clinically detectable in the assessment of quality of life [42]. The GSES was chosen because of its relevance to our research hypothesis and because of its sensitivity in the pilot study [25].

To demonstrate a difference ≥ 1.5 points (SD = 2) in pre/post-programme improvement in the GSES between the two groups (ratio 1:1) for our target population, 58 evaluable patients are required (1-beta = 80%; 2-sided alpha = 5%), i.e. 64 patients (32 patients/group) to be included in order to anticipate 10% of potentially non-evaluable patients. The experimental arm will be completed by 16 health professionals and 16 third persons, for a total of 96 participants.

Data analyses

The study data will be described by estimating means, standard deviations, medians, and extreme values for quantitative data, and by calculating frequencies and percentages for qualitative data, in each group and for each time period. Comparisons of patient characteristics according to randomisation group will be made using Student's t test for quantitative data or the non-parametric Wilcoxon-Mann–Whitney test if the data distribution is not Gaussian, and the Chi2 test for qualitative data or Fisher’s exact test, if necessary. The evaluation of health professionals’ and third persons’ data does not require comparisons between groups but only a description. A patient/health professional/participant will be considered evaluable for this study if he/she has completed at least one meditation session.

To meet the main objective, changes in the GSES self-efficacy score will be measured between inclusion and the end of the meditation programme in patients in the experimental arm and in patients in the control arm, and then compared between these two groups of patients using Student's t test or the Wilcoxon-Mann–Whitney test, if the distribution of GSES deltas is not Gaussian. The self-efficacy score observed at the end of the sessions will be modelled using a multivariable linear model adjusted for the score at inclusion, the patient arm and any confounding factors such as age or sex, in order to measure the added value for patients of the shared meditation programme.

The evaluation of the secondary objectives will be based on a descriptive comparison of the quantitative measures observed timepoint by timepoint in order to evaluate the effect of meditation in the three populations on the feeling of self-efficacy (GSES), perceived stress (PSS), the development of mindfulness (FMI) and self-compassion (SCS), quality of life (VAS) and burnout (MBI, for health professionals). To do so, Student's paired data test or the Wilcoxon-Mann–Whitney test will be used to compare pairwise the data of each group measured at inclusion, after the 12th session and after the three follow-up sessions. No repeated measures data analysis is planned in this study due to lack of power.

The benefits of meditating together, the participants’ satisfaction, their adherence to the programme and their perception of a change in their overall quality of life will be described at the different timepoints without statistical comparison.

The qualitative data will be analysed by a specialist in qualitative analysis using the anonymised verbatim transcripts of the recorded discussions. Axial coding of the verbatim transcripts per category using a content analysis grid will form part of the descriptive analysis. The interview transcripts will be analysed using NVivo software. A reflexive thematic analytic method will be used with a combination of deductive and inductive identification of themes [43]. The results will be sent to the research group for discussion as part of an interpretative analysis.

Data management

A web-based data capture system will be used for data collection and query handling. The investigator will ensure that data are recorded on the eCRFs, as specified in the study protocol and in accordance with the instructions provided. The investigator ensures the accuracy, completeness, and timeliness of the data recorded and of the provision of answers to data queries according to the clinical study agreement. The investigator will sign the completed eCRFs. A copy of the completed eCRFs will be archived at the study site.

Withdrawal from study

The reasons why a participant may withdraw from the study include the following:

• Intercurrent event, not compatible with the pursuit of the study

• Participant’s decision (the data already collected during the search can be kept and exploited unless he/she opposes it)

• Participant lost to follow-up

Discussion

Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach as part of their supportive cancer care. Meditation is sometimes provided, but its potential benefits have yet to be fully evaluated [21]. Although the data in the literature point to the beneficial effects of MM, they show heterogeneity, which complicates comparison between studies, and they even highlight the importance of considering the potentially adverse effects generated by the approach, such as fear and anxiety [22, 23].

The question then arises as to who should be offered it in a hospital setting. Some studies directly target the population concerned, i.e. patients, while others focus on the benefits of meditation for health professionals, who, by improving their well-being, would have a positive impact on the quality of care provided.

One-off experiments are sometimes offered simultaneously to patients and health professionals. Could we go even further? Our pilot study enabled us to validate the relevance of offering meditation in an open setting, involving not only patients and health professionals but also third persons [25], the latter making it possible to conduct the experiment outside the sole context of the illness and the hospital, which had never been explored before. Over and above the individual benefits that meditation can bring, particularly in terms of managing day-to-day stress, our project now aims to evaluate the hypothesis that there could be added value in meditating in a shared meditation context.

The originality of our approach also lies in the involvement of people with cancer in the project. Two patients (one from the pilot study and the partner patient employed by our comprehensive cancer centre) have indeed been invited to help us optimize the meditation programme. This is in line with the precept that patients can play an active role in designing their own care plan and is relevant to the construction of a programme that meets their needs as closely as possible. These partner patients also helped us to select questionnaires and review patient information notes. In addition to the partnership with patients, the study will be conducted in a multidisciplinary setting, notably thanks to the involvement of a philosopher in ethics and health who will provide the complementary skills essential for conducting research in integrative medicine.

This project paves the way for a new approach to supportive care in oncology, combining patient empowerment and humanized care. To date, very little research has been done in this area and it has not been evaluated, which means that the approach proposed here is innovative.

The main aims of our randomized study are to improve well-being, strengthen links between health professionals, patients and third persons, and raise awareness of the importance of living together better by offering meditation as a shared activity. The expected benefits of meditation therefore primarily concern the relief of psychological suffering. Promoting better understanding between health professionals and patients and looking at oneself and others in a different way are experiences that aim to encourage exchange and interaction between populations. For people with cancer, i.e. the target population of our study, pain and other symptoms associated with the disease and its treatment will be better managed. The expected development of psychosocial skills assessed by the feeling of self-efficacy is an asset that will empower patients, helping to them to be more active in their own care. The pain experienced by health professionals, which is essentially linked to professional overwork and contact with illness, will be managed by using meditation. This will benefit carers and the way they interact with their patients.

Developing a relationship based on trust that takes the specific nature of each person into account and supporting patients and their relatives in a holistic way are challenges that need to be met to prevent the dehumanization of care. The expected collective benefit is to develop and better experience our interdependence and humanity by recognizing suffering as a shared characteristic, despite the specific problems faced by each category of persons.

The study has public health implications. If it produces satisfactory results in terms of participation, adherence, and benefits thanks to meditation, particularly shared meditation, we will need to consider deploying the approach to other cancer care establishments in France. Its transferability and implementation will depend on the confirmation of our qualitative and quantitative data and on the reproducibility of the programme thanks to a rigorously validated methodological framework. Beyond the dissemination of meditation as a response to patients' needs and for promoting mutual benefit for health professionals and patients, the overarching aim is to alleviate suffering, which is an integral part of human experience, by cultivating our common humanity.